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The Drug Candidate Journey: Phase III

Statistically Proven

Phase III trials use a much larger patient population – in the thousands – to give statistical weight to results that can prove safety and efficacy. This phase helps determine the drug’s benefit-risk ratio. Averaging three years, Phase III trials consume the vast majority of overall investment – as much as 90 percent – because of the requirement for validation, larger size, and greater risk.

The Good News

Phase III successes move on to New Drug Applications or Biologics License Applications with the U.S. FDA and/or similar approvals from other global regulatory agencies.

We offer technology transfer and facility design services to prepare you for transitioning from clinical to commercial production.

Phase III Needs:

  • Capital, additional resources
  • Regulatory
  • QA/QC
  • Analytics
  • Formulation
  • Stability assessment
  • Raw material assessment/testing (ie., CoA, animal origin, etc. from vendors)
  • Technology/method transfers (internal or to CMO)
  • Equipment/machinery design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
  • Analytical method validation
  • Process knowledge at commercial scale; CMO considerations
Phase III Considerations
  • Funding
  • PD
  • Scale Up
  • Optimization
  • Regulatory
  • Formulation & Stability
  • Analytics
  • Tech Transfer
  • Facility Design & Implementation

Process scale-up and tech transfer

According to ICH Q10, the goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization.

Learn more on the points to consider for successful tech transfers.
> Watch our webinar: Managing process scale-up and tech transfer

> Watch our video: Development of a MAB process from benchtop scale to 2KL production scale.

Tech transfer your MAb production process with Provantage® End to End.

Single-use technologies

Today's single-use technologies can add flexibility to your facility. Learn how we have overcome transfer challenges and risks by implementing a strategy that utilizes single-use technologies.

> Watch our webinar: Process of the future: Cheaper, faster and safer with single-use technologies

> Read our article: "Process and Facility Design for a Monoclonal Antibody Facility", discusses how today's single-use technologies can add flexibility to a MAb facility.

For operational flexibility, the Mobius® Bioreactor Platform scales from small batch to full production capacity

Facility design

There are many challenges in designing and constructing a single production facility, so that it can produce different biosimilar monoclonal antibodies, from clinical studies through commercial production. Learn more on how to overcome these challenges.

> Watch our webinar: The chronicles of a Biosimilar production facility

Reduce your capital and operational expenses with confidence with Provantage® End to End


Step Product Loading L/m2 20L Scale
Recommended
Configuration
Part # 200L Scale
Recommended
Configuration
Part #
Primary Clarification Millistak+® D0HC 50 L/m2 1 x 1m2 D0HC MD0HC10FS1 5 x 1 1m2 D0HC MD0HC10FS1
Secondary Clarification Millistak+® X0HC 100 1 x 0.55m2 X0HC MX0HC05FS1 2 x 1.1m2 X0HC MX0HC10FS1
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Protein A Eshmuno® A 40 g/L 2 x 500 mL 1.20089.0500 10L 1.20089.9010
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Cation Exchange Eshmuno® CPX 60 g/L 2 x 500 mL 1.20083.0500 2 x 5L 1.20083.5000
Sterile Filtration Millipore Express® SHC 100L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Anion Exchange Eshmuno® Q 200 g/L 100 ml 1.20079.0100 2 x 500 ml 1.20079.0500
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Virus Filtration Viresolve® Pro 500L/m2 Modus 1.2 VPMD101NB1 2 x Magnus 2.1 VPMG201NB1
UF-DF Pellicon® 3 30kD Ultracel® 50g/m2/hr 0.5m2 cassette P3C030C00 4 x 1.14m2 cassette PcC0301C10
Sterile Filtration Millipore Express® SHC 150L/m2 XL 600 KHGEG015FF3 1 x 5" KHGEG05HH3

Phase III Fast Facts
  • Typical Starting Volume (estimate): 2000L
  • Typical timeline (in years): 3
  • Number of batches per molecule: 10

This chart lists common buffers and chemicals:

Product Pack Size Catalog Number
Sodium Chloride USP, EP, BP, JP (Emprove®) 1kg, 5kg 1.37017
TRIS USP, EP, BP, JPC (Emprove®) 1kg, 5kg 1.08386
Sodium Hydroxide USP, EP, BP, JP (Emprove®) 1kg, 5kg 1.06482
Phosphate Buffer multicompendial (USP, EP, etc.; Emprove®) 1kg, 5kg various
Supplements, Amino Acids (Emprove®) various
The Emprove® program includes over 400 products that meet the latest
regulatory requirements, with 24/7 online access to product information
and dossiers necessary to facilitate the qualification and approval process.
  • Funding

    Primary Need

    Lack of funding is one of the main reasons for failure of a biologic.

    Estimates vary, but some project it costs $8-10 million just to get to IND stage, another $8-10 million for Phase I, and $20-40 million for Phase II, depending on design. Phase III costs considerably more.

    Don’t let a good drug go to waste, or too much of its value to third parties, because of funding issues. There are ways to fund biotech, from biotech crowdfunding, nondilutive funding, and nonsoursive funding, to biotech grants, angel investors, venture capital and other resources.

    More >
  • Intellectual Property

    Intellectual property strategy is essential to protecting ideas and the business. Emerging biotech community members shared their insights.

    More >
  • Regulatory Guidance

    Stay the Course

    On the journey to commercialization, be sure to stay the course by understanding the global pharmaceutical regulatory landscape.

    We offer

    More >

Emerging Biotech: Stay Current

Advance Biotech Grant Program – Accelerating Therapeutic Development in Life Science

The Life Science business of MilliporeSigma is expanding its commitment to the global biotech community with its Advance Biotech Grant Program. Through the newly expanded grant program, every six months, three recipients around the globe will be awarded a total of €200,000 in free services and products to address their process development challenges. In total, six companies will benefit from the Advance Biotech Grant Program each year. Press Release

The Advance Biotech Grant Program (USA and Canada) is launching 01 November 2018.
Read more about the Advance Biotech Grant Program.


Find out more about our programs:

Bringing your molecule to market. As part of our commitment to meet the needs of the life science community, we’ve developed several programs that recognize stand-out emerging biotech companies. These programs are designed to support biotech start-ups and medium sized companies in solving their current bioprocess development challenges to bring the next generation of molecules to market.

More details about EB Programs>

WEBINAR: Venture Capital Funding: An Insider’s View

Learn more about the ABCs of venture capital including how it works and the role of a corporate venture capital.

Watch >


WEBINAR: Accelerated ADC Development with Integrated Supply Chain Solutions

Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.

Watch Now >


WEBINAR: RNA Based Therapeutics and Vaccines: Bioprocessing Technology Trends

Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.

Watch this Webinar >


WEBINAR: Managing Process Scale-up and Tech Transfer

Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.

Watch this Webinar >


Webinars On-Demand >

WHITE PAPER: 2017 Life Science Executive Summit

Establishing an open dialog within the biotech community....

Read more and download >


The Changing Biopharma Risk Equation

A report from the The Economist Intelligence Unit sponsored by MilliporeSigma.
This paper, which incorporates the results of a survey of 254 pharmaceutical executives from around the world and a range of interviews with industry experts, explores in detail global pharmaceutical companies' growth strategies and their plans for managing the associated risks.

Read the study >

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EMD Millipore is a part of Merck KGaA, Darmstadt, Germany.