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Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Manufacturing | Funding | Intellectual Property | Regulatory | EB Programs
Pre-clinical testing establishes that the target compound is safe and effective – before it can be tested in humans. The in vitro, in vivo and animal testing at this stage can take several years – as many as six.
The goal here is preparing and filing an Investigational New Drug (IND) application.
To cover toxicology and safety studies, prepare for manufacturing considerations, and outline clinical trials protocols, you need capital.
It is also helpful to begin understanding the regulatory requirements – so you’re staying the course and correctly tracking data you’ll need later when filing the IND.
Developing monoclonal antibodies (mAbs) that can make the full journey requires excellent science – and excellent tools.
Here is some of the high-tech gear you’ll need to ready your biopharmaceutical for its IND:
| 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 |
What you should know in pre-clinical testing to smooth the journey to Phase I of clinical trials:
Cell CultureLearn more how to manage cell line clonality during a process of cell line development for the production of recombinant proteins.
> Watch our video: Demonstration of cell line clonality during the process of cell line development.
Managing aggregates in a mAb process
How upstream unit operations including clone selection, process optimization such as nutrient optimization and oxygen availability can impact monoclonal antibody aggregation in your process.
> Watch our video: Managing Agreggates in your Monoclonal Antibody (mAb) Process: Upstream.
For a small-scale mAbs process that carries you to Phase I, here are some 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®) | 1kg, 5kg | various |
| Stabilizers, multicompendial (Sucrose, Sorbitol, Mannitol; Emprove®) | 1kg, 5kg | 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.
