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Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Manufacturing | Funding | Intellectual Property | Regulatory | EB Programs
Phase II tests the effectiveness of the biomolecule in actual patients with the disease or illness you’re attempting to treat. These years-long (three, on average) clinical trials involve a few hundred volunteers and help determine the drug’s safety, any side effects, and optimal dosing.
Phase II is high stakes, because determining efficacy is critical to obtaining the funding you need to continue testing. Learn more about funding requirements and how to obtain capital here.
Phase II Needs:
Find out where you can get process development services that reduce the time required to get cGMP biomolecules for your clinical trials. Virtual companies, especially, will need the assistance of a contract manufacturing organization (CMO). Learn about outsourcing to MilliporeSigma.
This reference guide shows our recommendations for 1L-3L and 20L-200L scale process development:
| Step | Product | Loading L/m2 | 1L Scale Recommended Configuration |
Part # | 3L Scale Recommended Configuration |
Part # |
| Primary Clarification | Millistak+® D0HC | 50 L/m2 | 1 x 540cm2 D0HC | MD0HC054H1 | 2 x 540cm2 D0HC | MD0HC054H1 |
| Secondary Clarification | Millistak+® X0HC | 100 | 1 x 270cm2 X0HC | MX0HC027H1 | 1 x 540cm2 X0HC | MX0HC054H1 |
| Sterile Filtration | Millipore Express® SHC | 1000L/m2 | XL 150 | KHGEG015FF3 | XL 150 | KHGEG015FF3 |
| • Protein A | Eshmuno® A | 40 g/L | 5mL column | 1.25161.0001 | 10mL bulk resin | 1.20089.0010 |
| Sterile Filtration | Millipore Express® SHC | 1000L/m2 | XL 150 | KHGEG015FF3 | XL 150 | KHGEG015FF3 |
| • Cation Exchange | Eshmuno® CPX | 60 g/L | 5mL column | 1.25157.0001 | 10mL bulk resin | 1.20083.0010 |
| Sterile Filtration | Millipore Express® SHC | 100L/m2 | XL 150 | KHGEG015FF3 | XL 150 | KHGEG015FF3 |
| • Anion Exchange | Eshmuno® Q | 200 g/L | 5mL column | 1.25074.0001 | 10mL bulk resin | 1.20079.0010 |
| Sterile Filtration | Millipore Express® SHC | 1000L/m2 | XL 150 | KHGEG015FF3 | XL 150 | KHGEG015FF3 |
| • Virus Filtration | Viresolve® Pro | 500L/m2 | Modus 1.1 | VPMD101NB1 | Modus 1.1 | VPMD101NB1 |
| • UF-DF | Pellicon® 3 30kD Ultracel® | 50g/m2/hr | 88cm2 device | P3C030C00 | 0.11m2 mini | P3C030C01 |
| Sterile Filtration | Millipore Express® SHC | 150L/m2 | XL 150 | KHGEG015FF3 | XL 150 | KHGEG015FF3 |
| 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 for a small-scale mAbs process, moving to Phase II:
| 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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Parenteral Drug Association (PDA) Technical Reports: #10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (fee applies)
Parenteral Drug Association (PDA) Technical Reports: #53 Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products (fee applies)
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.
