If you’re involved with drug development or manufacturing, you’re in a unique position. Every day, you are creating possibilities to improve human health. While others wonder what’s to come, you are building it. For decades, our customers have counted on MilliporeSigma’s commitment to quality, safety and reliability to help them pave the way to the science of tomorrow. Now you can leverage MilliporeSigma’s technological innovations to shape the future of pharmaceutical processing.
Whether you’re looking to refine the science, optimize processes or enhance operational efficiency, MilliporeSigma’s products and services will help you improve process economics, accelerate time to market and mitigate risk. Together, we can develop and apply next generation strategies today. Explore What’s Next with MilliporeSigma.
David Beattie, Ph.D., Head of Bioprocessing R&D, discusses how technology has shaped biomanufacturing and explores what’s next to help solve the toughest bioprocessing challenges
Audrey Chang, PhD, Global Head of Development Services explains how we continue to innovate in biosafety assessment, leveraging new molecular testing tools and sequencing technologies to make drug development and manufacturing safer, quicker, and more efficient.
Matthias Joehnck, Ph.D., Global Head of Actives and Formulation Research and Development, discusses how new technologies and applications help customers solve their toughest formulation challenges and provide high-quality active pharmaceutical compounds, accelerating the journey of new drugs to patients.
Danny Galbraith, Ph.D., Head of Production Characterization and New Services, talks about why product characterization is key to successful biological drug development. Learn more about the advanced methods used to ensure your biotherapy’s critical quality attributes (including product safety, purity, identify, and potency), from early stages to commercial release.
Click on a product or service to learn more about the science behind the innovation.
Cell line development requires identification of the right clone. This process is time consuming and resource-intense, and can feel like finding a needle in the haystack.
The CHOZN® platform allows for more rapid clone selection when isolating production cell lines and can save up to 8 weeks in your development time. The CHOZN® ZFN Modified GS-/- CHO cell line eliminates endogenous glutamine synthetase (GS), rendering the cells auxotrophic for the essential amino acid L-glutamine. As a result, a strong selection pressure can be achieved by simply removing glutamine from the cell culture media; there is no need for toxic, costly and less efficient GS inhibitor L-Methionine Sulphoximine (MSX). In addition, time-consuming amplification steps that often lead to an unwanted increase of gene copies and genomic instability can be avoided.
The CHOZN® platform also includes an optimized set of cGMP produced chemically-defined growth and production media and feed, providing you with a complete solution.
Conventional depth filters are made of naturally derived-materials such as cellulose and diatomaceous earth, and as a result, may lead to process variability and lot-to-lot inconsistency.
We have replaced each component of current diatomaceous earth-containing or cellulose filters with synthetic substitutions in our Millistak+® HC Pro depth filters, in the Pod format.
Millistak+® HC Pro Synthetic Depth Filters provide up to a 2x capacity increase for primary clarification applications along with the recommendation of 50% reduction in pre-use flush volumes.
Internal tests and customer trials supported the new synthetic media as primary and secondary depth filters for bioreactor clarification.
The Pod filter format was chosen as the initial device format, allowing you to leverage the hardware and operating procedures already in place in your manufacturing plants.
We have engineered the first-of-its-kind Pellicon® Capsule, a true single-use tangential flow filter that offers comparable performance to the industry leading Pellicon® cassette.
Through our innovative spiral technology, Pellicon® Capsule provides the efficiency you know and expect with the convenience of a pre-sterilized and self-contained format to easily facilitate single-use processing.
The Pellicon® Capsule simplifies ultrafiltration and diafiltration processes with its user-friendly features for improved process economics and speed to market.
Our new Pellicon® Capsule was designed to address customer needs including:
Trace amounts of anti-A and anti-B isoagglutinins in plasma-derived immunoglobulins have been associated with increased patient risk for hemolysis, a serious and sometimes fatal complication. Our scientists and engineers developed Eshmuno® P chromatography resins to address this challenge.
Eshmuno® P resins leverage the proven technology of highly stable Eshmuno® base matrix coupled with target specific ligands. Eshmuno® P resins are synthesized via immobilization of trisaccharide blood group antigens (A and B) on to the Eshmuno® base matrix, which is a rigid and hydrophilic polymer based on polyvinylether. The resins are released by an innovative test method to evaluate performance with significantly less variability compared to classical agglutination methods.
Functionalized PEGs can have critical purity parameters. Very small amounts of homobifunctional PEG content, for example, can trigger the formation of a high amount of high molecular weight species, resulting in purification concerns and considerable loss of high value material.
In collaboration with a customer, we developed an approach to achieve the desired quality of the functionalized PEG.
The resulting process improved the economic yield and outperformed the currently available quality. We are currently manufacturing a first commercial scale batch under GMP and plans for process validation are in place.
Mixing buffer and media can be challenging as the powder tends to float on the surface or sink to the bottom of the liquid. Having a single-use mixer with the versatility and capability to handle all these applications is critical to your process development or manufacturing.
Our engineers converted our NovAseptic® mixing technology, traditionally used in stainless steel, into a single-use format.
The Mobius® Power MIX family of single-use systems, offer more efficient mixing features that make them easy to use in size ranges from 100 to 3000 L.
With the industry facing ever increasing regulations, our Emprove® Program helps you meet the latest regulatory requirements for risk assessment and speed your way through the regulatory maze.
The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It also provides comprehensive and thorough documentation of our filters and single-use components as well as pharma raw and starting materials. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation.
The M Lab™ Collaboration Centers are a global network of resource hubs where you can explore ideas, learn innovative techniques, and collaborate to find solutions to your unique process development challenges, big and small. From process development and scale-up to troubleshooting and hands-on training, these labs located in North America, South America, Europe, and Asia offer you a non-GMP space to “experiment” without disrupting your production line.
Our process development scientists, representing nine non-GMP facilities around the world, specialize in helping you address any process challenge from upstream to downstream and final fill. Both hands-on and classroom-style customer education courses are offered in the M Lab™ Collaboration Centers or customized and delivered directly at your site.
To date, our global network of trainers within the M Lab™ Collaboration Center network have trained more than 10,000 people worldwide.
For more information on the M Lab™ Collaboration Centers and our global customer education program:
In biopharma, time is money. Companies are looking to successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. Decisions made early in clinical development can have significant impacts on the ultimate commercial success of a drug.
As an experienced partner, BioReliance® End-to-End Solutions understands these dynamics and offers the services needed to help biotech companies accelerate their drug development, from early clinical to commercial production. Our network of experts around the globe provides support for Biopharm process development, clinical-scale template, GMP clinical supply solutions, facility design and construction, and process scale-up and technical transfer.
Our first biodevelopment site in Martillac, France was built in 1987 for discovery to manufacturing scale activities for proteins. This GMP manufacturing production site is approved by the French Health Authority (ANSM) for cGMP related activities.
More recently we expanded our presence to North America and Asia. We now provide cell line development services, upstream and downstream process development, and non-GMP clinical production for drug manufacturers at our two new BioReliance® End-to-End centers in Shanghai, China (opened in 2017) and in Burlington, MA, USA (opened in 2018).
Collectively, the BioReliance® End-to-End team has executed approximately 240 large molecule projects ranging in scale from three to 2,000 liters.
With our extensive portfolio of Parteck® functional excipients, you can optimize and simplify your solid dosage formulation. Parteck® excipients offer unique particle properties and functionalities that optimize API release kinetics and enhance solubility and are backed by our stringent quality control and full regulatory support.
Antibody-drug conjugates present a unique set of challenges. Their development is complex and requires expertise in small and large molecules along with specific analytical methods. Instead of trying to assemble a set of suppliers, consultants and manufacturers, simplify the process with a single partner – MilliporeSigma.
We offer a comprehensive solution, integrated supply chain and purpose-built facilities for the crucial steps for ADC development and manufacturing: monoclonal antibody production, HPAPIs, linkers and complex bioconjugation. You’ll benefit from our 30 years of experience with more than 220 biologics and conjugation of more than 40 different constructs.
Our aging population, an increase in chronic diseases, the push for precision medicine, as well as intense competition, are driving the need to create therapies more quickly, safely and in a cost-effective way.
Given this environment, it is no surprise that the biopharmaceutical industry is actively seeking new approaches to development and manufacturing. Whether it is called continuous bioprocessing, process intensification next generation bioprocessing, process optimization or integrated, connected manufacturing, we are all exploring a new way forward.
No doubt, next generation bioprocessing will be the way our customers bring new therapies to market. By 2025 in fact, it is expected that 20% or revenue from mab molecules currently in the pipeline will come from drugs manufactured with next generation technologies(1).
Learn how we are advancing next generation bioprocessing through next generation thinking and innovation.