API Process Development Services from Abzena

Description

Abzena's process development, optimization and manufacturing teams work together to develop quality, commercially viable processes, that ensure a seamless scaleup directly from bench scale to final manufacturing through to commercialization.

Development capabilities include:
  • Experience with multiple mammalian cell types including CHO, ABZCHO K1, sp2/0, yp2/0, and NSO
  • Experience beyond mAbs including fabs, ADCs, oligonucleotides, nanoparticles, bispecifics, fusion proteins, vaccines, viruslike particles, enzymes, and bioconjugates
  • Transfer verification optimization of your process
  • Design of statistical experiments to optimize media feeds and growth conditions
  • Scale down fed batch and perfusion production models
  • Robotic systems from 250ml to manufacturing scale at 2K
  • High cell density and titer optimization
  • Bench scale process characterization and validation
  • Coordination with inhouse Analytical Method Development (AMD) to determine quality attributes