Drug Substance Biomanufacturing

OVERVIEW

How Biomanufacturing Works      Locations

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.

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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.

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LOCATIONS

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

Bioreactor/Scale:

• 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

Seed train:

• Traditional batch
• ATF (N-1 perfusion)

Bioreactor/Scale:

• 50L single-use stirred
• 20L-2,500L stainless-steel
• Delta V Control System

Oxford, U.K. (coming soon)

BIOMANUFACTURING VIDEO

Integrated Development, Analytical and Biomanufacturing Services at Bloomington, IN: