Drug Substance Biomanufacturing
Catalent Biologics’ drug substance biomanufacturing services provide flexibility and scale to support your growth. We offer a broad range of integrated process development and analytical services to solve your most difficult development and biologics manufacturing challenges. Catalent’s two state-of-the-art facilities utilize either single-use or stainless-steel bioreactors in a rigorous CGMP environment.
HOW BIOMANUFACTURING WORKS
Whether you are using a Catalent GPEx® technology-based cell line or your own cell line, we can design a robust production process capable of reliably producing your biologic under a rigorous CGMP environment.
Advantages of Catalent Biologics’ Drug Substance Manufacturing Services:
- The development and biomanufacturing teams work closely together to ensure scalability to full CGMP production.
- Co-located analytical laboratories support method development, in-process, release and stability testing.
- Global Catalent Quality System – inspection performance 2x better than industry average.
- Regulatory experience and approvals, including multiple inspections by regulatory bodies and biopharmaceutical company clients.
- Proven experience working with a wide variety of molecules, including: antibodies, fusion proteins, biosimilars, antibody fragments, and other complex recombinant proteins.
- Flexibility to support small, clinical and commercial stage programs.
- Ability to tech transfer later stage projects.
- Expertise in biosimilar development, bioanalytics and drug substance biomanufacturing.
Catalent Biologics – Madison, WI
State-Of-The-Art Biologics Manufacturing Using Single Use Technology
Flexible CGMP production scale up to 4,000L (2×2,000L) Single Use Bioreactors
- Sartorius ambr15
- 2L-10L glass
- 20L/50L rocking
- 20L/50L WAVE Single-Use
- 50L-2000L HyClone Single-Use
- Finesse Controllers
Catalent Biologics – Bloomington, IN
State-Of-The-Art Biologics Manufacturing Using Stainless Steel and Single Use Technologies
Flexible CGMP production scale up to 5,000L (2×2,500L) Stainless Steel Bioreactors
- Traditional batch
- ATF (N-1 perfusion)
- 50L single-use stirred
- 20L-2,500L stainless-steel
- Delta V Control System
Oxford, U.K. (coming soon)
Integrated Development, Analytical and Biomanufacturing Services at Madison, WI:
Integrated Development, Analytical and Biomanufacturing Services at Bloomington, IN: