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Biomanufacturing

Catalent Biologics’ 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 Biomanufacturing 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 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 (2x2,000L) 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 2x2,500L Stainless Steel Bioreactors

Bioreactor/Scale:

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

BIOMANUFACTURING VIDEOS

Integrated Development, Analytical and Biomanufacturing Services at Madison, WI:

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

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