Article Archives


2017
February 17, 2017
  • New Lynx® CDR Connector Sizes Bring Increased Flexibility to Your Process

    Issue: February 17, 2017
    Categories: Downstream, Upstream

    Now with a full range of sizes, the Lynx® CDR connector is available for use with multiple tube sizes.
    Read more »
  • Blood Plasma Website Gets Ultimate Makeover to Help Optimize Your Process

    Issue: February 17, 2017
    Category: Downstream, Formulation, Regulatory Topics, Upstream, MilliporeSigma Topics

    We’ve re-designed our blood plasma website to function as your gateway to critical blood plasma fractionation resources.
    Read more »
  • Webinar Presents How to Reduce Risk of mAb Aggregation in Bioprocessing

    Issue: February 17, 2017
    Categories: Downstream, Formulation, MilliporeSigma Topics, Regulatory Topics, Upstream

    Our webinar will explore how and why biological product aggregates form within a bioprocessing environment.
    Read more »
  • Winners of Emerging Biotech Grant Program Announced

    Issue: February 17, 2017
    Category: MilliporeSigma Topics

    We are excited to announce the winners of our 2016 Emerging Biotech Grant Program in Europe.
    Read more »

January 25, 2017
  • Webinar Explores Overcoming Regulatory Challenges of Implementing Single-Use Technologies

    Issue: January 25, 2017
    Categories: Upstream, Downstream, Regulatory

    Our webinar, “Overcoming Quality and Regulatory Challenges of Implementing Single-use Pharmaceutical Manufacturing,” will provide insight into industry and regulatory requirements for single-use pharmaceutical manufacturing systems.
    Read more »
  • Winner Chosen for 2016 Life Science Award in Bioseparations

    Issue: January 25, 2017
    Category: MilliporeSigma Topics

    On October 18, Ying Li, from The Pennsylvania State University, was selected as the winner of the EMD Millipore 2016 Life Science Award in Bioseparations.
    Read more »
  • High Performance Meets Ease of Use with Mobius® Power MIX Systems

    Issue: January 25, 2017
    Categories: Upstream

    The Mobius® Power MIX family of single-use mixing systems are engineered with advanced high performance technology to easily handle difficult-to-mix buffers, cell culture media powders and other pharmaceutical ingredients.
    Read more »
  • Creating Greater Access to More Affordable Vaccines Through Process Efficiency and Innovation

    Issue: January 25, 2017
    Category: Upstream, Downstream, Formulation

    Vaccines have the power to protect against disease and offer a better quality life. In many regions of the world, however, access to high quality vaccines at an affordable price is difficult.
    Read more »

2016
December 22, 2016
  • New Video Series on Managing Aggregates

    Issue: December 22, 2016
    Categories: MilliporeSigma Topics, Downstream, Formulation, Upstream, Regulatory Topics

    In this new video series, our experts discuss which steps in the biomanufacturing process are involved in the formation or removal of aggregates and their recommended solutions.
    Read more »
  • Webinar Presents Strategies for Mitigating Risk in Emerging Markets

    Issue: December 22, 2016
    Category: Regulatory Topics

    In early October, we presented a webinar, “Strategies for Mitigating Risk When Entering Emerging Markets,” in which we take a look at the changing biopharma landscape as well as strategies for scaling your process.
    Read more »
  • Build and Customize Upstream and Downstream Suites with New App

    Issue: December 22, 2016
    Categories: Downstream, Formulation, Upstream, MilliporeSigma topics

    This new app depicts a scalable biopharmaceutical process workflow for mAb and ADC manufacturing from research to commercial production.
    Read more »
  • Introducing Mobius® Power MIX 2000 for Difficult-to-Mix Biopharm Ingredients

    Issue: December 22, 2016
    Category: Upstream

    The Mobius® Power MIX 2000 single-use mixing system is the latest addition to the Mobius® portfolio of single-use technologies for biomanufacturing.
    Read more »

November 29, 2016
  • MilliporeSigma Honored with CPhI Excellence in Pharma Awards

    Issue: November 29, 2016
    Categories: Formulation, Regulatory topics, MilliporeSigma topics

    CPhI Pharma Awards recently honored MilliporeSigma for groundbreaking innovations in technology, formulation, regulatory procedures and product development.
    Read more »
  • New Parteck® MXP Excipient for Enhanced Solubility and Stable High Drug Loads

    Issue: November 29, 2016
    Categories: Bioavailability enhancement; Formulation

    We’ve launched Parteck® Melt Extrusion PVA (MXP), a new polyvinyl alcohol-based excipient which enhances solubility of a wide range of poorly bioavailable APIs.
    Read more »
  • State-of-the-Art M Lab™ Collaboration Center Opens in South Korea

    Issue: November 29, 2016
    Category: MilliporeSigma topics

    We are excited to announce the opening of our new M Lab™ Collaboration Center in the Songdo district of Incheon, South Korea, one of the fastest growing biotech hubs in Asia.
    Read more »

October 26, 2016
  • Calculations Made Easy with our Chromatography Volume & Flow Rate Tool

    Issue: October 26, 2016
    Categories: Downstream

    Scientists and engineers working on preparative chromatography routinely have to make calculations for column packing, process development, and scale up.
    Read more »
  • Tentacle Ion Exchange Chromatography Animation: How It Works

    Issue: October 26, 2016
    Category: Downstream

    Purifying a protein can be a challenging task – that’s why it is critical to choose the right chromatographic media and conditions.
    Read more »
  • Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

    Issue: October 26, 2016
    Category: Downstream, Upstream

    In a recently published article, an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation and delivery are presented.
    Read more »

September 27, 2016
  • New Presentation Highlights How to Make Novel Therapies a Reality

    Issue: September 27, 2016
    Categories: Downstream, Regulatory topics, Upstream

    A survey conducted by the Economist Intelligence Unit recently highlighted new products that the biopharma industry has identified as most disruptive to their growth strategies in the next five years.
    Read more »
  • Viresolve® Pro Shield H Combined with Viresolve® Pro Device Delivers High Parvovirus LRV, Capacity and Flux

    Issue: September 27, 2016
    Category: Downstream

    We are pleased to announce the newest member of the Viresolve® Pro Solution family – Viresolve® Pro Shield H, a membrane-based adsorptive prefilter that is used in conjunction with the Viresolve® Pro Device, providing you with unmatched viral clearance.
    Read more »
  • MVM Resistance Through Genetic Engineering

    Issue: September 27, 2016
    Category: Upstream

    Our unwavering commitment to be on the leading edge of risk mitigation strategies against adventitious agent contaminations has led us to a completely new approach to viral safety.
    Read more »
  • Overcoming Challenges of High Pressure Operations with SUS

    Issue: September 27, 2016
    Category: Upstream

    In a recent article, the pressure rating of the key available components in single-use assemblies were summarized and then compared independently as well as when joined together.
    Read more »

August 24, 2016
  • Excipients Portfolio Now Includes Polymers for Sustained Release Injectables

    Issue: August 24, 2016
    Category: Formulations

    Our excipients portfolio has expanded to now include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing customers to optimize and precisely control release kinetics of final drug products.
    Read more »
  • Explore, Learn and Collaborate at Our M Lab™ Collaboration Centers

    Issue: August 24, 2016
    Category: MilliporeSigma Topics

    Step into an M Lab™ Collaboration Center – and get a whole new perspective on your biomanufacturing challenges.
    Read more »
  • Empowering Biotech Startups to Solve Their Toughest Challenges

    Issue: August 24, 2016
    Category: MilliporeSigma Topics

    As part of our commitment to meet the needs of the life science community, we’ve developed several grant programs that recognize stand-out emerging biotech (EB) companies.
    Read more »

July 26, 2016
  • Emprove® Program Expands to Include Filtration and Single-Use Products

    Issue: July 26, 2016
    Category: Regulatory Topic

    We are pleased to announce that our industry-leading Emprove® program has expanded to include a selection of products for filtration and single-use processing.
    Read more »
  • Size-Exclusion Chromatography for Preparative Purification of Biomolecules

    Issue: July 26, 2016
    Category: Downstream

    In a recent article, application data to support the use of SEC beyond small-scale operations, using Fractogel® EMD BioSEC (S) resin was presented.
    Read more »
  • New High-Area Scaling Vodcast Series Now Available

    Issue: July 26, 2016
    Category: Downstream

    Recently, we developed a vodcast series that explores points to consider for reliable scale up of your filtration application, particularly using high area filters.
    Read more »
  • New Study Highlights Biopharma’s Current and Future Growth Drivers

    Issue: July 26, 2016
    Category: MilliporeSigma Topics

    We recently sponsored a study that was conducted by the Economist Intelligence Unit (EIU), in which 254 global biopharmaceutical executives were asked how their companies will manage new risks associated with the changing biopharma landscape.
    Read more »

June 22, 2016
  • Speeding Biosimilar Development Using Glycosylation Control Technology

    Issue: June 22, 2016
    Category: Upstream

    With strong growth in the biosimilars market competition is rife, as numerous companies fight to get their drug to market first and win market share.
    Read more »
  • Connect, Disconnect and Reconnect with New Lynx® CDR Sterile Connectors

    Issue: June 22, 2016
    Category: Downstream, Upstream

    We recently launched the Lynx® CDR Connector, providing users the ability to connect, disconnect and reconnect their single-use and hybrid systems, from upstream through downstream.
    Read more »
  • Webinar: Combined Dual pH/Salt Gradients for the Separation of Challenging Protein Variants

    Issue: June 22, 2016
    Category: Downstream

    Ion-exchange chromatography typically uses gradients of increasing salt concentration at a constant pH-value for elution; a technical approach that has been used at process scale in the biopharmaceutical industry for decades.
    Read more »
  • Best Practices for Critical Sterile Filter Operations

    Issue: June 22, 2016
    Category: Downstream

    In today’s biopharmaceutical industry, pre-use post-sterilization integrity testing (PUPSIT) is a widely used practice that detects damage that may have occurred during installation and sterilization.
    Read more »

May 24, 2016
  • New Mobius® 1000 L Single-Use Bioreactor Brings Ease of Use to Single-Use

    Issue: May 24, 2016
    Category: Downstream

    The new Mobius® 1000 L single-use bioreactor completes the comprehensive Mobius® stirred tank portfolio of 3 to 2000 L sizes, delivering greater flexibility and continuity for scale-up and reducing the need for re-training of operators during scale-up.
    Read more »
  • Webinar: Flow Through Chromatography and Adsorptive Depth Filtration for Continuous Processing

    Issue: April 26, 2016
    Category: Downstream

    Chromatography steps such as binding and elution can be challenging to implement in continuous processing. With step-wise load/wash/elute/clean cycles used, multiple columns are required to provide a continuous elution stream.
    Read more »
  • Paper Discusses How to Optimize Media Feeding Strategies

    Issue: May 24, 2016
    Category: Upstream

    Performance improvements of upstream mammalian bioprocesses can be accomplished through manipulation of cell line characteristics, adjustment of media and feed formulations, as well as optimization of process parameters.
    Read more »

April 26, 2016
  • High Throughput Screening of Resin Cleaning Procedures

    Issue: April 26, 2016
    Category: Downstream

    A recently published article describes the use of high throughput (HT) tools to assess cleaning agents for a mAb polishing step utilizing Fractogel® EMD TMAE HiCap (M) anion exchange (AEX) resin.
    Read more »
  • Webinar: High Viscosity UF Formulation for Plasma IgG and mAbs

    Issue: April 26, 2016
    Category: Downstream

    Ease of administration and high dose applications are driving the bioprocessing industry to formulate higher concentration biotherapeutics.
    Read more »
  • Chromatography User Group Meeting a Continued Success

    Issue: April 26, 2016
    Category: Downstream

    Our chromatography user group meeting recently took place in San Francisco, California on February 23-25, 2016.
    Read more »

March 22, 2016
  • Vodcast Series Highlights Final Fill Process Design Considerations

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    Final fill applications present complex challenges in a process where risks are high and every drop of the product is valuable. The many concerns at final fill include patient safety, product yield, and regulatory compliance.
    Read more »
  • Webinar: Recent Developments in Oral Sustained Release Formulations

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    Modified release formulations offer numerous opportunities, including the possibility to improve the therapeutic efficacy of a drug. Out of the numerous approaches for modified release, each has its own benefits and drawbacks, as there is no one-size-fits-all solution for modified release formulations.
    Read more »
  • Millipore Express® High Area Cartridges for Improved Efficiency

    Issue: January 26, 2016
    Category: Downstream

    We recently launched the Millipore Express® Sterile High Capacity (SHC) and Sterile High Retention with onboard Pre-filter (SHR+P) high area cartridges for increased productivity and process efficiency. The innovative design of these new membrane filters provides greater filtration capacity in a smaller footprint, improving filtration economics for biopharmaceutical manufacturing.
    Read more »

February 23, 2016
  • EDQM Grants New CEPs for Three Life Science API Products

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    The “Certificate of Suitability to the monograph of the European Pharmacopoeia” (CEP) is granted upon demonstration that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia.
    Read more »
  • Clarification Solution for High-Density Cell Culture Harvests

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    Clarification of harvested cell culture broth is crucial for the efficient reuse of Protein A columns in the purification of antibodies as the plugging components, such as cells and colloids, are removed. With recent advances in mammalian expression systems, the separation process has posed challenges due to the high proportion of solids and colloids.
    Read more »
  • New Webinar: How Excipient Suppliers Can Support QbD

    Issue: January 26, 2016
    Category: Downstream

    Pharmaceutical manufacturers are under increased pressure from health authorities worldwide to implement Quality by Design (QbD) principles for novel and generic drugs. By utilizing this approach, it provides increased control over product quality and excipient supply.
    Read more »
  • Updated Sterile Filtration Selection Guide Simplifies Process

    Issue: January 26, 2016
    Category: Regulatory topics, MilliporeSigma topics

    We are pleased to announce that advanced features have been added to our Sterile Filtration Product Selection Guide, making it even easier for you to find the right sterile filter for your application and process requirements.
    Read more »
  • New Webinar Highlights Benefits of Single-Pass TFF

    Issue: January 26, 2016
    Category: Regulatory topics, MilliporeSigma topics

    Continuous bioprocessing is generating considerable excitement in the biopharma industry as it promises to increase efficiency, decrease equipment footprint, reduce underused plant capacity and, ultimately, lower cost of goods.
    Read more »

January 26, 2016
  • Introducing Our New Brand

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    We are excited to announce that we launched our new brand identity. Our updated visual image is designed to represent a vibrant science and technology company, and is inspired by the colorful and multifaceted shapes seen under a microscope.
    Read more »
  • Updated Biopharmaceutical Application Guide: Find the Products and Services You Need for Your Process

    Issue: January 26, 2016
    Category: MilliporeSigma topics

    We are pleased to announce that our interactive Biopharmaceutical Application Guide now features three new markets – Plasma Factor VIII, Viral Vector Vaccines, and Virus-Like Particle Vaccines.
    Read more »
  • Save Time and Reduce Costs with Chromabolt® Prepacked Chromatography Columns

    Issue: January 26, 2016
    Category: Downstream

    Prepacked chromatography columns are on the rise in today’s biopharmaceutical industry. With the ability to increase plant flexibility and efficacy, drug manufacturers are utilizing these columns to get to market faster.
    Read more »
  • New White Paper Discusses How Suppliers Can Create a Safer Production Environment

    Issue: January 26, 2016
    Category: Regulatory topics, MilliporeSigma topics

    Proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment as well as operational efficiency. As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure their production environments are safe.
    Read more »

2015
December 16, 2015
  • Single-use final fill interactive guide now available

    Issue: September 29, 2015
    Category: Upstream

    Traditional formulation and final fill operations have productivity challenges that can limit process flexibility. With the number of clinical runs increasing and new drugs having smaller lot sizes and highly potent ingredients, manufacturers need to incorporate single-use technologies to respond to these demands.
    Read more »
  • Provantage® Tech Transfer Services: Your process train, where and when you need it

    Issue: September 29, 2015
    Category: Upstream

    Are you looking to tech transfer your existing mAb production process into a new facility? With Provantage® End-to-End Services, we have the products, services and partnerships you need to be successful.
    Read more »
  • Updated Drug Master Files for filtration devices now available

    Issue: September 29, 2015
    Category: Upstream, Downstream

    We are pleased to announce that we have updated and revised the United States Drug Master Files (DMFs) for our Durapore®, Millipore Express®, Viresolve® and Viresolve® NFR Filters with Retropore® membrane filtration devices.
    Read more »
  • Webinar: Process of the future: Cheaper, faster and safer

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Despite the introduction of new technologies, biotech processes still contain a number of open and at-risk transfer steps. Cell culture transfer from one vial to containers such as T-flasks or shake flasks, and then to the bioreactor, is usually one of these open at-risk phases.
    Read more »
November 24, 2015
  • You're invited: MilliporeSigma's 2016 Chromatography User Group Meeting

    Issue: September 29, 2015
    Category: Upstream

    We are excited to announce that our Annual Chromatography User Group Meeting dates have been released! Please join us at the Hyatt Fisherman's Wharf in San Francisco, California on February 23-25, 2016.
    Read more »
  • Webinar: Novel synthetic adsorptive depth filter media for CHO-S harvest clarification

    Issue: September 29, 2015
    Category: Upstream

    Recent advancements in the productivity of upstream cell culture processes for the manufacture of therapeutic proteins has resulted in greatly increased cell densities and higher levels of process-related impurities.
    Read more »
  • Customer seminar highlights innovative strategies in upstream processing

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Recently, MilliporeSigma successfully held its 2nd upstream seminar: "Bioproduction with confidence," in Darmstadt, Germany.
    Read more »
  • Poster: Production and purification of a VLP-based Hepatitis C vaccine candidate

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Virus-like particles (VLPs) have been proven to be a good vaccine technology platform due to safety and immunogenicity factors.
    Read more »

October 27, 2015
  • New video: final filtration made simple

    Issue: September 29, 2015
    Category: Upstream

    Final filling can be a complex and challenging unit operation for drug manufacturers. Product purity, yield, sterility assurance, and regulatory compliance are just some of the concerns at this step.
    Read more »
  • New Parteck® SRP 80 excipient - take control of drug release

    Issue: September 29, 2015
    Category: Upstream

    MilliporeSigma is excited to announce the newest addition to its Parteck® functional excipients portfolio, Parteck® SRP 80. This new excipient has been designed for more reliability and consistency in sustained-release solid dose formulations.
    Read more »
  • Benefits of cell culture based influenza vaccine inherent to processing

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Each year vaccine manufacturers are faced with challenges as they develop and produce the seasonal influenza vaccine.
    Read more »

September 29, 2015
  • Formalized risk assessment: Challenges and best practices

    Issue: September 29, 2015
    Category: Upstream

    In recent years, risk assessment has become an integral step for drug manufacturers in identifyingsuitable materials and consumables for their manufacturing processes.
    Read more »
  • Upstream services for fast-track manufacturing of proteins

    Issue: September 29, 2015
    Category: Upstream

    Biopharmaceutical developers are faced with increasing pressure to develop new drug products quickly and efficiently.
    Read more »
  • Provantage® End-to-End services: Biodevelopment from molecule to production

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Are you looking to expand the production of your recombinant proteins, vaccines or plasma commercial drugs? Do you need to bring affordable biosimilars to emerging markets?
    Read more »
  • New Emprove® program to facilitate risk assessment

    Issue: September 29, 2015
    Category: Regulatory Topics

    MilliporeSigma is excited to introduce new enhancements to our Emprove® program of pharmaceutical raw and starting materials.
    Read more »
  • New white paper offers insights from Emerging Biotech Executive Summit

    Issue: September 29, 2015
    Category: Upstream, Downstream

    Taking a biotech molecule from discovery to commercialization continues to be complex and challenging.
    Read more »

August 24, 2015
  • Industry best practices for TFF cassette reuse and storage

    Issue: August 24, 2015
    Category: Upstream, Downstream

    Tangential flow filtration (TFF) operations are an integral part of bioprocessing operations for clarification, concentration, diafiltration and formulation processes. If these processes occur immediately prior to final formulation
    Read more »
  • Experience ACHEMA through our new product spotlight videos

    Issue: August 24, 2015
    Category: Upstream, Downstream

    As one of the largest life science industry tradeshows, held every three years in Frankfurt, Germany, ACHEMA is an event that connects over 170,000 attendees from more than 300 countries.
    Read more »
  • Introducing our new LinkedIn® group: "Clarification Insights"

    Issue: August 24, 2015
    Category: Downstream

    The biopharmaceutical industry, particularly the area of clarification, is constantly evolving. As new and exciting advances emerge, it is imperative to have a platform where peers from around the world can engage with and learn from each other.
    Read more »
  • Beyond binding capacity: Chromatography resin manufacturers must find balance

    Issue: August 24, 2015
    Category: Downstream

    For many years, large-scale chromatography resins have been sold with much emphasis on binding capacity. However, it is important for chromatography resins to demonstrate a balance between capacity and selectivity with productivity and quality.
    Read more »

July 30, 2015
  • Introducing Provantage® Clone Generation Services

    Issue: July 30, 2015
    Category: Upstream, Downstream

    The production of recombinant proteins requires a high expressing and reliable cell line that is ready for GMP manufacturing. At MilliporeSigma, we understand this is a critical component for the development and production of a biological drug.
    Read more »
  • Introducing Mobius® 2000 L Single-use Bioreactor

    Issue: July 30, 2015
    Category: Upstream

    MilliporeSigma is excited to announce the newest member of the Mobius® bioreactor family – the Mobius® 2000 L single-use bioreactor; a scalable ergonomic system with the flexibility to fit your process.
    Read more »
  • IEX Chromatography: Optimization strategies for higher purity

    Issue: July 30, 2015
    Category: Downstream

    During the downstream processing of monoclonal antibodies (mAbs), ion exchange chromatography (IEX) is a crucial purification tool. Within the two types of ion exchange chromatography - cation exchange (CEX) and anion exchange (AEX)
    Read more »
  • Application of QbD Principles to Ultrafiltration Operations in Bioprocessing

    Issue: July 30, 2015
    Category: Downstream

    Today's biopharmaceutical industry is under pressure from regulatory organizations to meet increasing levels of compliance, and from pharmaceutical buying advocates and the financial community to show better operating economics.
    Read more »
  • New GDP guidelines for APIs

    Issue: July 30, 2015
    Category: Regulatory Topics

    This past March, the EU commission published new guidelines on the principles of Good Distribution Practice (GDP) of active substances for medicinal products for human use.
    Read more »

June 25, 2015
  • Challenges and promises of biosimilar upstream process development

    Issue: June 24, 2015
    Category: Upstream

    The need for affordable medications and the anticipation of blockbuster patent expirations have created great opportunities for biosimilars development.
    Read more »
  • Characterization of postcapture impurity removal

    Issue: June 24, 2015
    Category: Upstream

    During the virus inactivation and subsequent pH adjustment steps of a MAb manufacturing process, operators commonly observe a significant amount of precipitation and turbidity in their product pools.
    Read more »
  • Facilitating the IDL process with registered dossiers

    Issue: June 24, 2015
    Category: Regulatory Topics

    When manufacturing or selling drugs in China, Imported Drug Licenses (IDLs) are mandatory for imported drugs, APIs and pharmaceutical excipients.
    Read more »
  • Webinar: Solvent detergent viral inactivation

    Issue: June 24, 2015
    Category: Downstream

    Biomanufacturing plasma-derived products requires at least two orthogonal virus reduction steps to comply with regulatory pathogen safety risk mitigation guidelines.
    Read more »

May 21, 2015
  • Production and purification of virus-like particles

    Issue: May 21, 2015
    Category: Downstream

    Virus-like particles (VLPs) represent an appealing model for vaccine development, as they resemble native viruses but are not infectious.
    Read more »
  • Introducing Cellvento™ CHO media platform for top performance in cell culture

    Issue: May 21, 2015
    Category: Upstream

    Selecting the right medium to optimally match your cell line is a challenging task. Results have to be scalable, reproducible in every run and antibody quality attributes need to be consistent.
    Read more »
  • Protect your buffer process with new Millipore Express® PHF filters

    Issue: May 21, 2015
    Category: Downstream, Upstream

    The Millipore Express® PHF hydrophilic filter is the newest member of the Millipore® Express family of sterilizing grade filters. Designed for buffer process protection, it provides broad chemical compatibility, high flow rates
    Read more »
  • Dossier for New Chemical Entity approval

    Issue: May 21, 2015
    Category: API, Regulatory Topics

    At MilliporeSigma, we continuously strive to bring our regulatory expertise to the next level in order to better help you with your approval processes. One example of this is our regulatory documentation for active pharmaceutical ingredients.
    Read more »
  • Compacted Media: A new level of convenience in handling dry powder media

    Issue: May 21, 2015
    Category: Upstream

    Handling dry powder media can be challenging. To provide you with a new level of convenience, we have compacted the powder into granules. The resulting compacted media significantly minimize dust formation, improving media handling.
    Read more »

April 28, 2015
  • Strategies for Fab purification and formulation

    Issue: April 28, 2015
    Category: Formulation, Downstream

    Monoclonal antibodies (mAbs) continue to be an important class of therapeutics for the biotechnology industry. In recent years, however, increased attention has been devoted to the development of "next generation" biologic therapeutics.
    Read more »
  • Chromabolt® prepacked columns with new resins increase productivity

    Issue: April 28, 2015
    Category: Downstream

    We are pleased to announce that two additional chromatography resins, Fractogel® TMAE and Fractogel® DEAE are available in Chromabolt® prepacked columns for pilot and early clinical manufacturing.
    Read more »
  • Demystifying bioreactor contamination risks

    strong>Issue:April 28, 2015
    Category: Upstream

    The mitigation of bioreactor contamination risk is complex. Manufacturers can be lulled into a false sense of security, trusting that serum-free media eliminates such risks. However, the presence of contaminants such as mycoplasma can still exist.
    Read more »

March 24, 2015
  • MilliporeSigma announces winner of 2014 Emerging Biotech Grant Program

    Issue: March 24, 2015
    Category: Upstream, Downstream

    Committed to helping advance lifesaving drugs to market, MilliporeSigma hosted its first emerging biotech grant program last year, awarding one company up to $89,000 in products and services to help develop their molecule.
    Read more »
  • Updated Sterile Filtration Product Selection Guide now available

    Issue: March 24, 2015
    Category: Upstream, Downstream

    We are pleased to announce that advanced features have been added to our Sterile Filtration Product Selection Guide, making it even easier for you to find the right filter and services based on your application and process requirements.
    Read more »
  • New! Formulation Product Finder App

    Issue: March 24, 2015
    Category: Formulation, API, Bioavailability

    Having trouble finding the right product for your formulation? Quickly find a solution with our new Formulation Product Finder App for tablets.
    Read more »
  • An efficient way to increase capacity, recovery and concentration

    Issue: March 24, 2015
    Category: Upstream, Downstream

    MilliporeSigma is pleased to introduce Single-Pass TFF with Pellicon® cassettes, an enhanced application of our existing TFF technology that allows you to concentrate process streams without the recirculation required in traditional TFF steps.
    Read more »

February 26, 2015
  • Production and purification of plasmid DNA vaccines

    Issue: February 26, 2015
    Category: Upstream, Downstream

    The demand for plasmid DNA (pDNA) has vastly increased over the past decade in response to significant advances that have been made in its application for gene therapy and vaccine development.
    Read more »
  • New Guideline on Elemental Impurities and its implications

    Issue: February 26, 2015
    Category: Regulatory Topics, Formulation

    The ICH recently published the guideline ICH Q3D to control elemental impurities, which will have a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide. The EMA announced that the new requirements
    Read more »
  • Impact of process loading on TFF microfiltration

    Issue: February 26, 2015
    Category: Upstream, Downstream

    Tangential flow filtration (TFF) microfiltration is one of the choices for clarification of mammalian cell or microbial cell culture in the biopharmaceutical industry. Unlike ultrafiltration, TFF microfiltration is limited by a maximum throughput
    Read more »

Janary 28, 2015
  • Newly expanded Interactive Application Guide available

    Issue: January 28, 2015
    Category: Upstream, Downstream, Formulation

    Our Biopharmaceutical Application Guide, an online tool that helps you find the right MilliporeSigma solution for your process needs, is now even more comprehensive.
    Read more »
  • Examining single-use MIX vessels with protein solutions

    Issue: January 28, 2015
    Category: Upstream

    The increasing implementation of single-use equipment and assemblies in biopharmaceutical processes has resulted in more flexible facilities with faster batch-to-batch and product-to-product turnaround times.
    Read more »
  • GDP for APIs: Support from APIC "How to" document

    Issue: January 28, 2015
    Category: Regulatory Topics

    Until recently, specific regulations on Good Distribution Practices (GDP) for distributors of APIs were not required. However, with the EU Falsified Medicines Directive (Directive 2011/62/EU) the application of GDP for APIs is now becoming mandatory.
    Read more »

2014
December 17, 2014
  • Save time using our sizing tool for buffer filtration

    Issue: December 17, 2014
    Category: Downstream, Upstream

    Buffer solutions are a key requirement in various process steps of pharmaceutical and biotechnology therapeutics including: cell culture media, chromatography, ultrafiltration, diafiltration, and final formulation.
    Read more »
  • New webinar highlights how to cope with challenges of quality agreements

    Issue: December 17, 2014
    Category: Regulatory Topics

    Negotiating a quality agreement is time-consuming. Our recent webinar, "Quality agreements for pharmaceutical raw materials," was created to help inform you of the considerations you need to take into account for pharma raw materials.
    Read more »
  • New application data for PVA portfolio increases efficiency

    Issue: December 17, 2014
    Category: Bioavailability, Formulation

    In order to provide the best support for your formulation processes, and help you save time and make your work more efficient, we have collected new application data for our PVA portfolio, including dissolution rate.
    Read more »

November 26, 2014
  • Webinar: Best practices for PD using small-scale Millistak+® filters

    Issue: November 26, 2014
    Category: Upstream, Downstream

    Clarification of mammalian cell culture harvest remains an important step in biotherapeutic production. With advancements in capacity of depth-filtration media and the move towards single-use, clarification via two-step depth filtration.
    Read more »
  • Upcoming webinar to discuss PureFlex™ Plus single-use film

    Issue: November 26, 2014
    Category: Downstream

    Biopharmaceutical companies are using single-use containers and assemblies for upstream and downstream processes at an ever increasing rate. Today's films must meet the demands of new applications, especially the requirements of high volume.
    Read more »
  • Introducing the new NovaSeptum® single-use holder

    Issue: November 26, 2014
    Category: Downstream

    Sampling your product is critical throughout the manufacturing process to ensure quality and compliance with regulations. Improper sampling can lead to quarantine, repeat of analysis and sometimes in worse case scenarios, deviation or loss.
    Read more »
  • Highlights of latest revision of EU GMP Guidelines

    Issue: November 26, 2014
    Category: Regulatory Topics

    In August 2014, the EU commission published revisions to Chapter 3 "Premises and Equipment" and Chapter 5 "Production" of the EU GMP guideline, that will take effect on March 1, 2015.
    Read more »

October 28, 2014
  • In the media: clarification article in BPI

    Issue: October 28, 2014
    Category: Downstream

    We are pleased to announce that in the current issue of Bioprocess International (BPI) a paper authored by Sarah Le Merdy, a Field Marketing Specialist at MilliporeSigma, is published.
    Read more »
  • Compacted cell culture media: Improving stability and solubility

    Issue: October 28, 2014
    Category: Upstream

    We invite you to join us on November 13, as we present the webinar, "Compacted cell culture media: Improving the homogeneity, stability, solubility and convenience of dry powder cell culture media."
    Read more »
  • Celebrating 10 years of EMPROVE® qualification

    Issue: October 28, 2014
    Category: Regulatory Topics

    In 2004, MilliporeSigma anticipated the upcoming trend of stricter regulations for excipients that would require drug manufacturers to create more efficient documentation for pharmaceutical products. For this reason, we defined a standard method.
    Read more »

September 25, 2014
  • Leachables case study: Adopting single-use to improve speed to clinic

    Issue: September 25, 2014
    Category:

    As the opportunity to use single-use technologies throughout the clinical/manufacturing pipeline expands, there is a heightened risk of leachables being present in the drug substance. This leads to an increased incentive to evaluate, understand.
    Read more »
  • Don't miss our 2014 Chromatography User Group Meetings

    Issue: September 25, 2014
    Category: Downstream

    MilliporeSigma's Annual Chromatography User Group Meetings are right around the corner. Join us in Tiburon, CA with your chromatography peers to share best practices, exchange common industry observations and identify existing challenges.
    Read more »
  • Cellvento™ CHO cell culture medium portfolio expands

    Issue: September 25, 2014
    Category: Upstream

    With Cellvento™ CHO cell culture media, you have come to rely on superior chemically defined, non-animal origin media formulations for batch and fed-batch mode operations. Now, MilliporeSigma is excited to announce that we have expanded our portfolio.
    Read more »

July 23, 2014
  • Webinar: Reducing costs in solid dose formulations

    Issue: July 23, 2014
    Category: Bioavailability, Formulation

    Formulation is no easy task. With budgets being a constant concern, manufacturers are forced to decrease costs throughout their process. However, choosing the cheapest excipient may not be the best solution when considering the overall cost.
    Read more »
  • New chromatography resins available in Chromabolt® pre-packed columns

    Issue: July 23, 2014
    Category: Downstream

    Chromatography columns are evolving. Within the biopharmaceutical industry, pre-packed columns are becoming a more attractive option, providing significant time savings and facility flexibility. Extensively validated pre-packed columns.
    Read more »
  • New global website, new experience

    Issue: July 23, 2014
    Category: MilliporeSigma Topics

    We are pleased to announce the launch of our new website – We listened to your feedback and have developed an improved user experience, with even better ways to access information.
    Read more »
  • Interactive Biopharmaceutical Application Guide now available

    Issue: July 23, 2014
    Category: MilliporeSigma Topics, Upstream, Downstream, Formulation

    We are pleased to announce the launch of our new Biopharmaceutical Application Guide, an online, interactive tool aimed at helping our customers find the right MilliporeSigma solution for their process needs.
    Read more »

June 24, 2014
  • Webinar series: Final filling process design considerations

    Issue: June 24, 2014
    Category: Downstream

    The final filling operation for any drug product is one of the most critical steps in your manufacturing process. One wrong move can not only impact patient safety, but also your revenue. Implementing single-use technologies is one way companies are.
    Read more »
  • New webinar on impact of FDASIA for API and excipient suppliers

    Issue: June 24, 2014
    Category: Regulatory Topics

    The Food and Drug Administration Safety and Innovation Act, (FDASIA) was signed into law on July 9th 2012 and became effective on October 1st, 2012, strengthening the FDA's ability to safeguard and advance public health.
    Read more »
  • Best practices: Nucleic acid removal from vaccine processes

    Issue: June 24, 2014
    Category: Upstream, Downstream

    The production of viral vaccines at commercial scale requires large quantities of viruses as an antigenic source. Because host cell residuals can be found in the final product, nucleic acids in particular, there is the chance of transfer.
    Read more »

May 20, 2014
  • We did it again: FDA audit successfully passed

    Issue: May 20, 2014
    Category: API, Regulatory Topics

    In February 2014, the U.S. Food and Drug Administration (FDA) once again inspected MilliporeSigma's active pharmaceutical ingredients (APIs) at their Darmstadt, Gernsheim and Schaffhausen sites. All were found without any observation (no form 483).
    Read more »
  • Innovative batch traceability with new online tool

    Issue: May 20, 2014
    Category: Formulation, API, Regulatory Topics

    Supply chain transparency is essential in today's pharmaceutical market. Recognizing that the origin of a product is critical for our customers, MilliporeSigma has launched eOMT, an electronic Original Manufacturer Tracking tool. eOMT fulfills the USP.
    Read more »
  • Conquer high concentration challenges: new Pellicon™ 3 cassettes with D screen

    Issue: May 20, 2014
    Category: Downstream

    The need to process high concentration liquid formulations is driven by the desire to create injectable therapies. Traditionally many of these therapies were administered by infusion. For patients, injection means ease of administration.
    Read more »

April 16, 2014
  • MilliporeSigma expands portfolio of high-purity biological buffers

    Issue: April 16, 2014
    Category: Downstream

    With the introduction of MES, HEPES Na, MOPS and MES Na, MilliporeSigma has expanded its portfolio of biological buffers, which have broad applications in large-scale biomanufacturing, predominantly in downstream processing.
    Read more »
  • New FMDV LinkedIn® group connects industry experts

    Issue: April 16, 2014
    Category: Upstream

    Recently, MilliporeSigma created a LinkedIn® group for the Foot and Mouth Disease vaccine (FMDV) community to enable experts to network and discuss challenges and trends in FMDV production.
    Read more »
  • Interactive NovaSeptum® tool helps find the right configuration for your specific sampling challenge

    Issue: April 16, 2014
    Category: Downstream

    For many biopharmaceutical companies, closed single-use sampling offers countless benefits over traditional sampling methods including speed, risk mitigation and ease of operation.
    Read more »
  • Biosimilars: The impact of variability in manufacturing

    Issue: April 16, 2014
    Category: Regulatory Topics

    Biotechnology products are highly complex and even slight changes, often resulting from modifications in how they are manufactured, can negatively affect their safety and efficacy profile.
    Read more »

March 20, 2014
  • Supporting your process: risk assessment guidelines on excipients

    Issue: March 20, 2014
    Category: Regulatory Topics

    At MilliporeSigma, we strive to stay up-to-date on the latest regulatory proceedings so we can fully support your process – keeping you informed about any changes you need to be aware of, as well as making sure these requirements are followed.
    Read more »
  • Optimize your formulation with synthetic lipids

    Issue: March 20, 2014
    Category: Bioavailability

    Lipids can be difficult to utilize in your manufacturing process. Their waxy appearance can result in slow dissolution rates and challenges with handling larger lipid amounts. Lyophilization improves these properties but also increases the material's.
    Read more »
  • New porous silica structure overcomes drug solubility challenges

    Issue: March 20, 2014
    Category: Bioavailability, Formulation

    With an increasing number of drug candidates failing in development, the pharmaceutical industry is facing a shortage of new drugs. Poor bioavailability causes over 40% of these failures, often due to low solubility.
    Read more »
  • ChromaTALK™ moves to LinkedIn®

    Issue: March 20, 2014
    Category: Downstream

    There is no question that social media is changing the way we communicate with each other. For professionals, LinkedIn® is one of the most popular platforms today, allowing us to connect with colleagues, share information and stay up-to-date.
    Read more »

February 18, 2014
  • Minimize caking of products with DRYPOUR™ packaging system

    Issue: February 18, 2014
    Category: MilliporeSigma Topics

    For production without delays and optimum product quality, the right packaging of raw materials is essential. Hygroscopic salts in particular need protection against caking caused by moisture in their packaging.
    Read more »
  • Cyclodextrin HPB: A path to better API solubility and stability

    Issue: February 18, 2014
    Category: Bioavailability, Formulation

    MilliporeSigma's hydroxylpropyl-beta cyclodextrin is an ideal choice to effectively increase API solubility and stability. Due to its characteristics -- a molecule that resembles a hollow cone with a hydrophilic exterior and a more hydrophobic.
    Read more »
  • New superdisintegrant for solid formulations

    Issue: February 18, 2014
    Category: Bioavailability, Formulation

    MilliporeSigma's product family of excipients is growing. The new superdisintegrant, Parteck® CCS (Croscarmellose Sodium), expands our portfolio for solid formulation.
    Read more »
  • CellPrime® r Insulin improves cell culture performance

    Issue: February 18, 2014
    Category: Upstream

    Insulin is a pivotal component in cellular carbohydrate metabolism, as it not only enhances cell growth but also protein production. MilliporeSigma's CellPrime® r Insulin is your answer for improving the performance of your cell culture process.
    Read more »

January 22, 2014
  • Solve process development challenges with Provantage® Services

    Issue: January 22, 2014
    Category: Upstream, Downstream

    As drug manufacturers, you not only need to ensure your drug development and production process is reliable, but you must also ensure the quality of your product while keeping your costs low.
    Read more »
  • Protect your protein: TRIS high purity

    Issue: January 22, 2014
    Category: Downstream

    TRIS buffer systems are frequently used in the downstream purification of biomolecules - a process step where contamination with unknown impurities is highly unwanted.
    Read more »
  • Final filling: process design considerations

    Issue: January 22, 2014
    Category: Downstream

    Final filtration and filling of your drug product is one of the most critical points in the manufacturing process. Product quality must be guaranteed to ensure patient safety. In addition, any filtration steps must be capable of satisfying system.
    Read more »
  • Celebrating our 400th EMPROVE® product

    Issue: Issue: January 22, 2014
    Category: Formulation, MilliporeSigma Topics

    MilliporeSigma is pleased to welcome the 400th product to our EMPROVE® family. Pharmacopoeial potassium nitrate is now part of a portfolio of 400 active pharmaceutical ingredients, excipients and biopharmaceutical materials.
    Read more »

2013
December 17, 2013
  • MilliporeSigma partners with Developing Countries Vaccine Manufacturers' Network to aid in vaccine education

    Issue: December 17, 2013
    Category: Upstream, Downstream

    As a leader in vaccine manufacturing processes, MilliporeSigma is committed to lending a hand in making information quickly available to vaccine manufacturers in developing countries.
    Read more »
  • Find the right sterile filter with our interactive app

    Issue: December 17, 2013
    Category: Downstream

    Sterile filtration is just one step in a complex process with many variables. To help you easily determine the right sterile filtration products you need, we have created a Sterile Selector Tool.
    Read more »
  • Elemental impurities: Updates on USP, ICH and EMA guidelines

    Issue: December 17, 2013
    Category: Regulatory Topics

    The pharmaceutical industry is faced with an evolving number of guidelines that affect the control of elements -- primarily metals -- for drug products and ingredients such as APIs and excipients.
    Read more »
  • Annual chromatography user group meetings provide forum for thought leadership

    Issue: December 17, 2013
    Category: Downstream

    MilliporeSigma recently hosted its annual chromatography user group meetings in Washington, D.C. This event, which was broken into two meetings for Protein A affinity and ion exchange chromatography, enabled global end users to not only share.
    Read more »

November 20, 2013
  • The conversion from stainless steel to single-use: what you need to know

    Issue: November 20, 2013
    Category: Downstream

    Traditional stainless steel equipment is increasingly being replaced with disposable technologies in both new and existing processes, allowing for more flexibility, higher efficiencies and lower costs.
    Read more »
  • Optimize your cell growth with Fetal Bovine Serum (FBS)

    Issue: November 20, 2013
    Category: Upstream

    Despite the increasing shift towards using chemically defined media for cell culture, there are still many cell lines that require the use of serum-based media, making it imperative to have a high-quality Fetal Bovine Serum (FBS).
    Read more »
  • New ready-to-use cleaning solution for chromatography resins

    Issue: November 20, 2013
    Category: Downstream

    Chromatography is a process step which is performed with high value resins that require sanitization between batches, as well as prior to storage. While NaOH, the most widely used sanitant in bioprocessing, is very effective for polymer based resins.
    Read more »
  • New liquid media portfolio: flexibility at every scale

    Issue: November 20, 2013
    Category: Upstream

    More stringent safety regulations and the need for increased security in the biopharmaceutical industry have also led to enhanced safety standards for liquid media.
    Read more »
  • Liquid-liquid porometry - measure PSD and predict LRV

    Issue: November 20, 2013
    Category: Downstream

    Virus removal, using membrane filtration based on size exclusion, is dictated by pore size distribution (PSD) of the membrane. However, information characterizing pore size distribution of virus filters, and comparisons of quantitative predictions.
    Read more »

October 17, 2013
  • Parteck® SLC enhances drug bioavailability

    Issue: October 17, 2013
    Category: Formulation, Bioavailability

    The pharmaceutical industry is facing a shortage of new drugs -- existing patents are expiring and therapeutic pipelines are shrinking, as an increasing number of drug candidates fail in development. The cause for up to 40% of these failures is poor.
    Read more »
  • Clarification made easy with pDADMAC flocculation reagent

    Issue: October 17, 2013
    Category: Downstream

    In today's biopharmaceutical industry, high-density cell culture processes pose a significant threat to clarification and purification operations. With high solid content and an increased number of submicron particles.
    Read more »
  • Add safety to your process with our new encoded quick connector

    Issue: October 17, 2013
    Category: Downstream

    Discharging liquid chemicals from their packaging without compromising quality and purity during manufacturing can be a critical process step. Even more important is protecting employees.
    Read more »
  • Solve your GMP production challenges with Provantage® Services

    Issue: October 17, 2013
    Category: Upstream, Downstream

    We understand that drug manufacturers face the major challenge of moving a molecule to clinic faster and more reliably. With more than 25 years of experience in the production and purification of recombinant proteins within mammalian cells.
    Read more »

September 26, 2013
  • Introducing Clarisolve® depth filters for faster, more efficient primary clarification of pretreated feed streams

    Issue: September 26, 2013
    Category: Downstream

    The current evolution to high cell density and product titer cell cultures is placing a large burden on traditional downstream clarification and purification operations. To alleviate this bottleneck, various types of pretreatment options.
    Read more »
  • Gain a competitive edge with Eshmuno® A chromatography media

    Issue: September 26, 2013
    Category: Downstream

    When it comes to chromatography, we understand the challenges of efficiently capturing your final product, while minimizing costs and speeding time to clinic. Product titers and impurities are steadily increasing, placing even greater demands on.
    Read more »
  • Prepacked chromatography columns: the new trend in biopharmaceutical manufacturing

    Issue: September 26, 2013
    Category: Downstream

    In the interest of cutting costs, reducing production time and increasing plant flexibility, the biopharmaceutical industry has made a marked shift toward single-use manufacturing. One of the fastest growing segments of single-use technologies.
    Read more »
  • Solve your processing challenges with Provantage® Services

    Issue: September 26, 2013
    Category: Upstream, Downstream

    The processing challenges you face throughout your manufacturing process demand a new approach. Whether it is accelerating time to market, product quality or improving productivity, there is a new way.
    Read more »
  • The headquarter of MilliporeSigma passes first EXCiPACT™ audit

    Issue: September 26, 2013
    Category: Regulatory Topics, MilliporeSigma Topics

    Merck KGaA, Darmstadt, Germany, headquarter of MilliporeSigma, has become one of the first companies to successfully complete a comprehensive EXCiPACT™ audit; a third-party certification for manufacturers, suppliers and distributors of pharmaceutical.
    Read more »

July 31, 2013
  • Virus safety in upstream processing

    Issue: July 31, 2013
    Category: Upstream

    As part of a robust upstream process, many biotherapeutic manufacturers seek to execute a three-pronged virus safety strategy. This involves carefully sourcing raw materials, screening for adventitious viruses, and implementing process steps.
    Read more »
  • TRIS and phosphate buffer test kits now available

    Issue: July 31, 2013
    Category: Downstream

    With the addition of three new products, our range of top-quality buffers is now wider than ever. TRIS-hydrochloride, TRIS high purity, and MES-Na are now available in EMPROVE® bio grade quality.
    Read more »
  • Our NovaSeptum® single-use sterile sampling system

    Issue: July 31, 2013
    Category: Downstream

    When sampling your product to assure quality, it's vital to avoid both process and sample contamination. An inaccurate or false positive result can lead to quarantine – as well as the need to repeat the analysis.
    Read more »
  • Our full-service liquid formulation offering

    Issue: July 31, 2013
    Issue: Formulation

    From buffers, solvents, and preservatives to stabilizers, thickeners, surfactants, and flavors, MilliporeSigma has a wide portfolio of innovative raw materials for liquid dosage forms – including special excipients for ophthalmic and oral liquid.
    Read more »
  • Our new Research & Development Center for Formulation

    Issue: July 31, 2013
    Category: MilliporeSigma Topics

    Bioavailability enhancement is a key topic in the industry these days – and when our new Research & Development Center for Formulation (RDCF) opens in Q2 2013, we'll be ready to develop additional products that deliver.
    Read more »
  • Our comprehensive stem cell production portfolio

    Issue: July 31, 2013
    Category: Upstream

    Stem cells have tremendous potential in the fields of clinical and drug, but to produce them successfully on an industrial scale, you need a partner who can supply exactly the right tools and production systems for your individual cell culture.
    Read more »
  • New USP standards for elemental impurities

    Issue: July 31, 2013
    Category: Regulatory Topics

    Under the new USP standards, manufacturers will be required to prove that their finished drug products meet standards regarding elemental impurities. The stricter USP standards reflect a growing understanding of the toxicology of elemental.
    Read more »
  • Mobius® FlexReady Solution with Smart Flexware® assemblies

    Issue: July 31, 2013
    Category: Downstream

    When therapeutic manufacturers purify their biopharmaceutical products, flexibility is key. In addition to high performance, our Mobius® FlexReady Solution with Smart Flexware® assemblies is designed to enable fast changes from chromatography to TFF.
    Read more »
  • Cellvento™ CHO-200 medium for fed-batch mode

    Issue: July 31, 2013
    Category: Upstream

    Designed especially for fed-batch mode, our new CellventoTM CHO-200 medium, together with its complementary feeds, is the perfect match for CellventoTM CHO-100. Like its sister product, this chemically defined, non-animal origin medium is carefully.
    Read more »
  • Eshmuno® CPX media for high-production downstream bioprocessing

    Issue: July 31, 2013
    Category: Downstream

    The key challenge during intermediate purification and polishing is the ability to remove impurities similar to the target molecule, even at high loading levels. With Eshmuno® CPX media, you can efficiently remove mAb dimers and higher molecular.
    Read more »
  • E X-CYTE® growth enhancement media supplement

    Issue: July 31, 2013
    Category: Regulatory Topics

    When it comes to supplementation requirements and feeding strategies, mammalian cell lines are much more demanding than unicellular prokaryotes. For fine-tuning media composition and culture scale-up, it pays to work with an experienced partner.
    Read more »
  • Comprehensive liquid media portfolio from MilliporeSigma and Biochrom

    Issue: July 31, 2013
    Category: Upstream, Downstream

    Following the completed acquisition of Biochrom AG, MilliporeSigma can now offer a combined innovative product range. Our comprehensive capabilities feature liquid cell culture media and buffers, including serum-free products.
    Read more »

June 20, 2013
  • Coming soon to Darmstadt: our new R&D center for formulation

    Issue: June 20, 2013
    Category: Bioavailability, Formulation, API
    When our new excipient research laboratories open in Darmstadt in Q1 2013, we'll be able to provide even better support for your pharmaceutical formulation – with ultra-modern equipment, a wide range of progressive technologies, and highly qualified.
    Read more »
  • EMPROVE® bio continues to grow – with TRIS HCl and Gua HCl

    Issue: June 20, 2013
    Category: Downstream, Upstream
    In the past, TRIS hydrochloride (used as a buffer during biochromatography, along with TRIS) and guanidinium chloride (used for dissolving inclusion bodies and purifying chromatography resins) were available in technical qualities only.
    Read more »
  • Fewer refusals: MilliporeSigma now offers group audits

    Issue: June 20, 2013
    Category: Regulatory Topics, MilliporeSigma Topics
    At MilliporeSigma, we take openness and transparency seriously. We see our customers as partners with whom we collaborate closely – and providing insights into manufacturing processes and quality assurance is an integral part of this relationship.
    Read more »
  • How authorities and enterprises are reinforcing the safety of the pharmaceutical supply chain

    Issue: June 20, 2013
    Category: Regulatory Topics
    As recent years have shown, falsified medicinal products and sub-standard raw materials are a big problem in today's globalized pharmaceuticals market. After all, the reputation of suppliers and producers – and more important still, patient safety.
    Read more »
  • How Parteck® SI and Candurin® make your tablets stand out

    Issue: June 20, 2013
    Category: Formulation
    These days, tablets need to be robust, firm, release their actives quickly ... even looks matter! With so many boxes to tick, it's no wonder demands on production processes are growing too.
    Read more »
  • New – in EMPROVE® api quality

    Issue: June 20, 2013
    Category: API
    Two more MilliporeSigma products now offer tailor-made documentation for swift, smooth approvals, and can be used without hesitation in the field of active ingredients: magnesium chloride hexahydrate cryst and calcium chloride dihydrate.
    Read more »
  • Optimized TRIS now available in new purity grade

    Issue: June 20, 2013
    Category: Downstream, Upstream
    In our book, the best way to improve performance is by avoiding complacency, and continuously monitoring and challenging your own processes. Take TRIS, for example – a buffer for pH adjustments in downstream purification.
    Read more »
  • Our cell culture media milling technology in Darmstadt

    Issue: June 20, 2013
    Category: Upstream
    As everyone knows, a chain is only as strong as its weakest link. That's why at MilliporeSigma, we value the quality of raw materials and good formulation so highly. Stable, reliable production processes are vital too – for instance when manufacturing.
    Read more »
  • Our new Square Boxes are more than just containers

    Issue: June 20, 2013
    Category: MilliporeSigma Topics
    Square, practical, innovative ... our new Square Boxes have several advantages over conventional plastic drums. Take transport, for example: The footprint of 37 × 37 centimeters is perfect for CP 5 palettes; the capacity of 52 liters is higher...
    Read more »
  • Part of the pilot phase: Rx-360 audits MilliporeSigma

    Issue: June 20, 2013
    Category: Regulatory Topics
    Our world is converging. The pharmaceutical industry and raw material suppliers have been feeling the effects for years – and are responding with various initiatives designed to create global standards and cooperation for quality and safety.
    Read more »
  • Parteck® Mg DC now available in EMPROVE® grade

    Issue: June 20, 2013
    Category: Formulation
    We now offer Parteck® Mg DC, our directly compressible magnesium hydroxide carbonate, as an EMPROVE® product. This product takes the load off machines by ensuring high densities even at low compression rates, while the high mineral content means.
    Read more »
  • Ready for tomorrow: our new production plant for inorganic salts

    Issue: June 20, 2013
    Category: Formulation, Regulatory Topics, MilliporeSigma Topics
    As a supplier of inorganic salts, the best way to meet increased demand tomorrow is by being one step ahead today. That's why we've invested in an ultra-modern production plant for inorganic salts in Darmstadt.
    Read more »
  • Two new products make the grade: IPTG and Poloxamer 188

    Issue: June 20, 2013
    Category: Upstream, Downstream
    After completing our rigorous supplier qualification process, we're proud to announce two new products in our range. Isopropyl-?-D-thiogalactopyranoside (IPTG) is used for bacterial fermentation, particularly of E.-coli bacteria.
    Read more »
  • Work more efficiently – with CellPrime™ animal-free products

    Issue: June 20, 2013
    Category: Upstream
    Life originates from a single cell; and ideally, new products originate from cell cultures. So when you're working with cell culture media in research or production, batch-to-batch consistency and reproducible results are vital.
    Read more »
  • EMPROVE® api protects drug approvals with gapless documentation

    Issue: June 20, 2013
    Category: Regulatory Topics, Formulation, API
    Today's expectations in the pharmaceutical industry: getting to the market fast. Today's reality: complicated regulatory requirements which slow approvals and renewals down. EMPROVE® api helps to get expectations and reality closer together again.
    Read more »
  • Join ChromaTALK™, our online forum for chromatography professionals

    Issue: June 20, 2013
    Category: MilliporeSigma Topics, Downstream
    As part of the ChromaTALK™ community, your opinion matters. Wherever you are in the world, this interactive online forum gives you the opportunity to share your thoughts on the latest innovations, best practices, and the challenges the industry.
    Read more »
  • MilliporeSigma Probumin® – the No.1 BSA brand

    Issue: June 20, 2013
    Category: Upstream
    With over 50 years of experience in protein fractionation, MilliporeSigma is the world's biggest manufacturer of top-quality albumins. And in the field of biopharma and in-vitro diagnostics (IVD), our Probumin® Bovine Serum Albumin (BSA).
    Read more »
  • Mobius® MIX 1000 L mixer and Powder Delivery System

    Issue: June 20, 2013
    Category: Upstream
    With twice the capacity and all the features you expect from a Mobius® single-use mixer, the new Mobius® MIX 1000 L mixer saves biopharmaceutical manufacturers more time and effort than ever.
    Read more »
  • More comprehensive GMP documentation in cell culture production

    Issue: June 20, 2013
    Category: Regulatory Topics, Upstream
    In the interest of patient safety, GMP provisions become more stringent in the EU. All steps in cell culture production of APIs will soon need to be documented and monitored to GMP standards from the master cell bank stage onwards.
    Read more »
  • New: Parteck® ODT in EMPROVE® exp quality

    Issue: June 20, 2013
    Category: Formulation, Bioavailability
    Now that Parteck® ODT is an EMPROVE® product, customers will find it even harder to resist. This superior directly compressible, ready-to-use excipient is easy to formulate and handle, and permits up to 50 % active ingredients in direct-compressible.
    Read more »
  • Our activated multi-arm PEGs

    Issue: June 20, 2013
    Category: Bioavailability, Formulation
    Some products are specialists, others get more versatile all the time – for example, activated multi-arm PEGs*. Thanks to MilliporeSigma, these innovative developments are currently proving their value in the field of medical devices.
    Read more »
  • Our new electronic change control management system

    Issue: June 20, 2013
    Category: Regulatory Topics
    At MilliporeSigma, we understand that customers need to know right away when a process change affects the quality of the raw materials we supply. That's why we've just launched a new state-of-theart electronic change control management system.
    Read more »
  • Sweet news with Sucralose

    Issue: June 20, 2013
    Category: Formulation
    With its sweet, sugar-like taste and high process stability, MilliporeSigma sucralose is ideal for masking off-notes in liquids and solid formulations. And now that the European Pharmacopoeia declaration is available, this product really does tick all.
    Read more »
  • Quality first: EMPROVE® grade CaHPO4

    Issue: June 20, 2013
    Category: Forumulation
    As any manufacturer knows, microbiological contamination in CaHPO4 can seriously disrupt production schedules. So to minimize your risk and help you produce more smoothly, we now produce it ourselves – to the highest quality standards possible.
    Read more »
  • Success through collaboration: MilliporeSigma Beijing Skywing

    Issue: June 20, 2013
    Category: Upstream
    As the acknowledged expert for processes and bioreactor construction in China, MilliporeSigma Beijing Skywing offers a personal, start-to-finish service that helps animal health companies develop vaccine production processes more efficiently.
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  • The benefits of our crystalline DOTAP

    Issue: June 20, 2013
    Category: Bioavailability, Formulation
    DOTAP containing liposomes are well established for in-vitro experiments. Our crystalline-grade DOTAP is also suited for in-vivo transfection of polynucleotides – and can even be used as an adjuvant to stimulate immune response in vaccine.
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  • Activated PEGs for protein PEGylation

    Issue: June 20, 2013
    Category: Bioavailability, Formulation
    The body's immune system and enzymatic processes can degrade and metabolize proteins. As a result, the duration of action of therapeutic proteins is often rather short. Fortunately, researchers have found a way to prolong the desired efficacy.
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  • Audits have started at our Inorganic Salts Production Plant

    Issue: June 20, 2013
    Category: Formulation, MilliporeSigma Topics, Regulatory Topics
    Our state-of-the-art plant in Darmstadt is running smoothly, and is open for onsite audits. Your business partner will be happy to inform you about our audit procedures.
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  • Bioavailability enhancement solutions from MilliporeSigma

    Issue: June 20, 2013
    Category: Formulation, Bioavailability
    MilliporeSigma offers broad experience and deep application know-how in the field of bioavailability enhancement. As a full-service provider, we have everything you need to optimize development and reduce time to market.
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  • Cellvento™ CHO-100 cell culture media

    Issue: June 20, 2013
    Category: Upstream
    Designed especially for fed-batch mode, our new Cellvento™ CHO-200 medium, together with its complementary feeds, is the perfect match for Cellvento™ CHO-100.
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  • Bioavailability enhancement – the key to success for pharmaceutical drug products

    Issue: June 20, 2013
    Category: Bioavailability, Formulation
    Poor bioavailability is a hot topic in the pharmaceutical sector. While novel APIs, including biological molecules such as proteins and peptides, are particularly prone, API reformulations can also be affected.
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  • Cell culture media specialist Biochrom joins Merck

    Issue: June 20, 2013
    Category: Upstream, Downstream
    With the upcoming acquisition of Biochrom AG*, we look forward to offering pharmaceutical and biopharmaceutical manufacturers even more ways to reduce the complexity of production. Biochrom's innovative product range features liquid cell culture.
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  • CellPrime™ r Insulin now available

    Issue: June 20, 2013
    Category: Upstream
    Thanks to an exclusive agreement with our partner Julphar, supplies of our top-quality recombinant human insulin are now available under the MilliporeSigma CellPrime™ brand name. This advanced product is the perfect complement for our existing range.
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  • m,p-Xylene from MilliporeSigma

    Issue: June 20, 2013
    Category: Formulation
    We are pleased to announce that we have relaunched m,p-Xylene (mixture of isomers) to complement our broad range of excipients. Manufactured in accordance with cGMP regulations, MilliporeSigma m,p-Xylene consists of a unique isomeric composition.
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  • Our EMPROVE® quality PVA

    Issue: June 20, 2013
    Category: Formulation, Bioavailability
    Although polyvinyl alcohol (PVA) is such a familiar product, it always pays to order it from MilliporeSigma. There are three good reasons for this: consistent quality, purity, and strict regulatory compliance.
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  • Our Globally Harmonized Labels

    Issue: June 20, 2013
    Category:MilliporeSigma Topics, Regulatory Topics
    In a global business like pharmaceuticals, manufacturers need universal standards and procedures that are accepted all over the world. That way they can ship products they source in one region anywhere else – knowing there will be no problems on.
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  • Our organic and inorganic buffer range

    Issue: June 20, 2013
    Category: Upstream, Downstream
    When it comes to optimizing your protein's pH value – and stabilizing it while protecting it from contamination – MilliporeSigma buffers are ideal.
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  • Parteck® ODT formulations with an aqueous coating

    Issue: June 20, 2013
    Category: Formulation, Bioavailability
    Who says you can't have it both ways? Now you can even coat the tablets you create with Parteck® ODT – without affecting their disintegration rate.
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  • Under the new GDUFA program, manufacturers support FDA targets

    Issue: June 20, 2013
    Category: Regulatory Topics
    To reduce the growing backlog of approval applications from generics manufacturers, the FDA has recently introduced a five-year program called the GDUFA (Generic Drug User Fee Amendment). Under the new scheme, the FDA is authorized to collect fees
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  • With our two new chromatography products

    Issue: June 20, 2013
    Category: Downstream
    With the addition of two new products, our chromatography portfolio is now broader than ever – and we're committed to expanding it continuously. PharmPrep® P 100 RP18e sorbent is our latest silica sorbent.
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June 19, 2013
  • The EXCiPACT™ certification scheme

    Issue: June 19, 2013
    Category: Regulatory Topics

    When patient safety is your top priority, it clearly makes sense to verify all the ingredients in medications, not just some of them. Yet while active pharmaceutical ingredients are strictly regulated, there is still no formal legislation.
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  • New EMPROVE® api products: Urea cryst. and Potassium chloride

    Issue: June 19, 2013
    Category: API

    Since urea is so popular in skin creams and dermatological applications, we decided to help customers stay on the safe side – by becoming the first supplier to offer urea in EMPROVE® api quality with even higher purity.
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  • Our glycine in EMPROVE® exp quality

    Issue: June 19, 2013
    Category: Formulation

    With so many customers seeking reliable supplies of top-quality glycine, we decided the best solution was to produce it ourselves – in Germany. As a result, you can now order Glycine EMPROVE® exp – straight from us, the manufacturer.
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  • The new Falsified Medicines Directive

    Issue: June 19, 2013
    Category: Regulatory Topics

    Falsified medicines are a major threat to global health and safety. Most of them are fake products that masquerade as the real thing, but can be much stronger or weaker – and are usually of dubious quality.
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  • Low dosage and Parteck® M

    Issue: June 19, 2013
    Category: Formulation

    Did you know? One in five oral formulations now contains highly potent APIs in extremely low dosages. For tablet manufacturers, these 'highly potents' can be highly challenging too: the particles of low-dose APIs are far smaller.
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  • CellPrime™ recombinant human lysozyme – for in-culture protein extraction

    Issue: June 19, 2013
    Category: Upstream

    As any specialist will confirm, expressing protein in a bacterial system is easy; the hard part comes afterwards, when you need to extract it in a functional form. Now there's a new MilliporeSigma product that meets this challenge and can improve.
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  • How our API-grade meglumine enhances bioavailability

    Issue: June 19, 2013
    Category: Bioavailability, Formulation, API

    When you consider how closely organic counter-ions like meglumine interact with the drug substance itself, it obviously makes sense to use the best quality you can find. And when you order from MilliporeSigma, you can be sure of getting the finest.
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  • Extractables study for packaging of GMP solutions

    Issue: June 19, 2013
    Category: Downstream

    At MilliporeSigma, we believe in doing things properly. So when biotech customers asked us to verify the leach resistance of the containers we use for CiP and process solutions, we responded right away.
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  • The new Mobius® CellReady 200 L bioreactor

    Issue: June 19, 2013
    Category: Regulatory Topics, Upstream

    Looking for a single-use bioreactor that's reliable, robust, and easy to use? Our new Mobius® CellReady 200 L fits the bill perfectly. Designed to deliver reliable mammalian cell culture performance at pilot and clinical scale.
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  • Our DMEM/F12 makes the difference

    Issue: June 19, 2013
    Category: Upstream

    Just because it's a standard medium doesn't mean it comes with standard levels of quality and support. Take DMEM/F12 (for CHO media developments).
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  • Rebranding our portfolio with the new MilliporeSigma logo

    Issue: June 19, 2013
    Category: MilliporeSigma Topics

    How do you eat an elephant? One bite at a time, according to the old saying. We don't know if that's true – but it certainly works for the 'mammoth' task we are currently involved in: rebranding our whole portfolio with the new MilliporeSigma logo.
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June 18, 2013
  • Growing together: Merck and the Chinese market leader for cell culture media

    Issue: June 18, 2013
    Category: Upstream, MilliporeSigma Topics

    'X xùn!' is Chinese for 'good news.' So why are we brushing up on our Asian language skills? Because Merck has recently acquired the Chinese market leader for animal origin free cell culture media, a company called Beijing Skywing Technology.
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  • Why does Merck have more than one EMPROVE® portfolio?

    Issue: June 18, 2013
    Category: Regulatory Topics, API

    You can't use diesel if your car needs gasoline – and you can't use excipientgrade raw materials for demanding API applications. So to make life easier (and prevent costly mix-ups), Merck offers separate EMPROVE® portfolios for both fields of work.
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  • MilliporeSigma hosts the first Rx-360 Consortium global open day meeting

    Issue: June 18, 2013
    Category: Regulatory Topics

    In our book, the best way to keep counterfeit materials out of the global pharmaceutical supply chain – and hence ensure patient safety – is by building and monitoring a global quality system.
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  • Preventing the spread of foot-and-mouth disease

    Issue: June 18, 2013
    Category: Upstream, MilliporeSigma Topics

    It's been nine years since the last outbreak of foot-and-mouth disease swept Latin America, the UK, and mainland Europe. But as a recent FAO report indicates, there is still a real danger of contamination for microbiological culture media.
    Read more »
  • Is there a recipe for excellence?

    Issue: June 18, 2013
    Category: API

    Our Analytics service has an outstanding reputation for reliable, tailor-made service – but why, exactly? We asked Dietmar Oeter, Ph.D., for an impromptu analysis of what makes his own team so successful.
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  • Independent audit certifies the Eshmuno® management systems

    Issue: June 18, 2013
    Category: Downstream

    As anyone who's had their passport photo taken knows, impartial instruments are seldom flattering. Sometimes, though, that objective view is just what you need.
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  • Challenging the economies of scale in mAB production

    Issue: June 18, 2013
    Category: Upstream

    Demand for vaccines and biosimilars is increasing all the time.* So how come biomanufacturing is talking about overcapacity instead of struggling to keep up? Answer: As upstream titer yields are now so high, there's no need for all that capacity.
    Read more »
  • Our all-round approach to high-productivity downstream purification

    Issue: June 18, 2013
    Category: Downstream

    It's often said that ion exchange chromatography is the 'workhorse of column chromatography.' Actually, though, our latest products and solutions are more like a racehorse: powerful, lean, and purpose-built for speed an performance.
    Read more »