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Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Manufacturing | Funding | Intellectual Property | Regulatory | EB Programs
Phase I means you’ve filed your IND and are ready to begin evaluating your drug in humans.
More funding – in the millions – will be necessary to survive the average three-year span of Phase I clinical trials. These test the drug in a group of 20-80 healthy individuals to determine:
Phase I Needs:
For information on early innovation funding opportunities, visit MS Ventures or learn about the outcomes from our first Emerging Biotech Executive Summit and download the EB Summit white paper (PDF). Learn how to capture a higher share of your molecule’s value by avoiding premature transfer, capital expenditure, and staffing costs.
While you may reside in a biotech incubator and commercial manufacturing may seem years away, now is the time to plan for scaling up so you end this journey with a product that is ready for commercial distribution. Therefore, process development is critical.
Find out where you can get process development services that reduce the time required to get cGMP biomolecules for your clinical trials.
This reference guide shows our recommendations for 1L-3L 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 I:
| 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: #57 – Analytical Method Validation and Transfer of Biotechnology Products (fee applies)
Parenteral Drug Association (PDA) Technical Reports: #57-2 – Analytical Method Development and Qualification for Biotechnology Products (fee applies)
Formulation On-Demand Webinar: Enhancing Bioavailability with Inorganic Drug Carriers; presented by Gudrun Birk, Head of Controlled Release, MilliporeSigma and Dr. Alena Wieber, Head of Customized and Oral Formulations, MilliporeSigma
Formulation On-Demand Webinar: Enhancing the Solubility of Low Soluble Drugs with an Established, Monographed Excipient; presented by Dr. Hans-Leonhard Ohrem, Portfolio Development Manager, MilliporeSigma
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.
