Rapid biologics development to maximize your speed to clinic
Whether you are using a Catalent GPEx® technology-based cell line or a client-derived cell line, we can design a process for your project that can be easily transferred to our production plant. All operations from cell line development through production of preclinical and/or clinical (Phase I/II) API can be performed in a single facility with a dedicated project manager – thus ensuring better continuity and reliability. Backed by experts in the fields of molecular biology, cell line development, process development, biopharmaceutical manufacturing, and quality systems, we are able to streamline processes, and enhance performance, and speed through to clinical production.
Catalent Benefits
- Program development and scale-up
- Rapid timelines through cell line creation, MCB candidate selection, upstream and downstream development and clinical production
- Experience with a multitude of cell lines (both GPEx® and non- GPEx® lines)
- Experience in transferring client processes and rapid process improvements
- Flexibility to target client needs with program development
- Process development
- Optimized processes for growing GPEx® technology cell lines in serum-free media
- Scalable processes for both recombinant proteins and antibodies
- Development studies aimed at ensuring the maximum production and yield of the target protein
- Experience in optimizing protein glycosylation
- Extensive expertise in transferring, improving, and developing purification processes
- Quality systems
- Designed to match facility compliance with high-quality documentation practices
- cGMP compliant
- Over 60 cGMP lots manufactured
- Over 40 MCBs released
- Project management
- All operations from cell line development through production of preclinical and/or clinical (Phase I/II) API performed in a single facility with a dedicated project manager
- Direct access to our scientists
- Constant communication with project leaders
- Strategic consulting
- Consultative, strategic approach to biopharmaceutical development
- Streamlined processes to cut development time and costs while improving chances for success
- Maximizing your speed to clinic while maintaining the highest standards of quality
Catalent Services
- Generation of master and working cell banks
- Cell line stability studies
- Upstream process development in shake flask and bioreactor systems (2L - 10L)
- Downstream process development at the milligram to 100s gram scale
- Scale down and non-cGMP production (up to 100L) in disposable and stainless bioreactors
- cGMP manufacturing of Phase I / Phase II material in product-dedicated suites using stirred tank bioreactors at the 200L scale
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