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Clinical Manufacturing

 

CGMP Mammalian Cell Culture & Bacterial Fermentation

  • Master/Working Cell Banks production.
  • Monoclonal Antibody production for Phase I/II clinical studies.
  • Hollow-fiber technology, stirred tank technology and Wave™ bioreactors, from 25-liter to 750-liter (working volumes).
  • 80-liter fermentation to express recombinant proteins, natural products, and DNA plasmids.
CGMP Mammalian Cell Culture & Bacterial Fermentation CGMP Mammalian Cell Culture & Bacterial Fermentation CGMP Mammalian Cell Culture & Bacterial Fermentation

CGMP Downstream Purification

  • Bacterial system protein and inclusion body isolator and protein refolding.
  • Mammalian expressed protein purification and virus inactivation/clearance.
  • Process chromatography, high speed separations and filtration methodologies.

CGMP Aseptic Vialing

  • Aseptic filling capabilities include validated manual and semi-automatic filling processes.
  • Services include complete labeling and packing of the final dosage unit.
  • Unit sizes from 2 mL to 10 mL, up to 10,000 units per batch.
GMP Aseptic Vialing GMP Aseptic Vialing GMP Aseptic Vialing

CGMP Virus Production

  • Equipment that utilizes Cell Factory (adherent) and Wave™ bioreactor (microcarrier and suspension) technology.
  • Platform technology:
    • Viral vaccine production for adenovirus, herpesvirus, poliovirus, etc.
GMP Aseptic Vialing GMP Aseptic Vialing