GMP Manufacture

Abzena provides cGMP production and purification for recombinant proteins, antibodies, gene therapy products and vaccines for use in preclinical and phase I and II clinical trials. Abzena has extensive experience in the use of single-use technology which provides flexibility in the production process. The services provided include:

  • Mammalian expressed monoclonal antibodies and other recombinant proteins from 1L to 1,000L in batch or fed batch mode and up to 15,000L in perfusion mode
  • Microbial expressed recombinant proteins up to 100L scale
  • Master and Working Cell Banks in 100, 200 and 300 vial configurations
  • Scale up of downstream purification processes including harvest, clarification, chromatography, nano-filtration, and formulation
  • Conjugation of antibodies and proteins
  • Release of Drug Substance
  • Final fill/finish of Drug Product up to 2000 vial configuration
  • Release of Drug Product

Working with Abzena

Abzena’s contract development and manufacturing services are tailored to each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results in a timely manner. To get more information, a quote or to schedule a teleconference please contact us.

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