Drug Substance & Development

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From Bench through Commercialization

As part of our extensive contract development and manufacturing service offerings we use advanced technologies and innovative solutions to efficiently develop and manufacture compliant and quality products, including monoclonal antibodies, complex proteins, and recombinant proteins.

Cell Line Development

Asymchem Biologics Process Dev and Drug Substance

Cell Line Development Services

  • Cell line generation
  • Clone screening
  • Cell line selectionCell banking services (Research and GMP)
  • Options for GS (Glutamine Synthetase) knock-out cell line with robust and highly productive titers

Drug Substance Process Development

  • Bioreactor development including batch versus fed batch
  • High-throughput protein purification process development
  • Non-GMP and GMP Pilot (200L / 500L) manufacture capacities
  • Stability on drug substance

Drug Product Development

  • QbD formulation screening
  • Stability studies
  • Non-GMP / GMP pilot aseptic liquid filling