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Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Manufacturing | Funding | Intellectual Property | Regulatory | EB Programs
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.
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:
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.
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
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 |
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. |
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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
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.
Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.
Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.
Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.
Establishing an open dialog within the biotech community....
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.
Research. Development. Production.
We are a leading supplier to the global Life Science industry: solutions and services for research, development and production of biotechnology and pharmaceutical drug therapies.
