CLINICAL MANUFACTURE OF BULK DRUG SUBSTANCE

The highly segregated manufacturing facilities allow CMAB to handle multiple products in parallel.  Single-use tanks are used in both media- and buffer-preparation to minimize risk of cross-contamination and allow rapid product change-over.

In the upstream area, four different products can be cultured simultaneously, one in each of the separate cell culture rooms

  • Fully Single-use technology
  • Inoculation and expansion using Wave (GE and Sartorius) or 50L Bioreactor
  • Cell culture capacities of 200L, 500L, 1000L with GE and Sartorius Platforms
  • Batch and fed-batch operation
  • Harvest by depth filtration: Multi-stage capability

Downstream processing equipment with the dual trains can be rapidly configured to handle batch sizes entering from harvested cell culture fluid of 200g to 5kg

  • Chromatography: ÄKTAProcess and ÄKTAReady, isocratic and gradient
  • Single-use virus inactivation (low pH and detergent) and filtration
  • Ultrafiltration and diafiltration to perform concentration and buffer exchange
  • Bulk drug substance filling using closed system under Grade A supply air.

The downstream area can handle two products in parallel with equipment sized to complete the production in less than 5 days for a typical Mab purified with three chromatography operations.

Bulk Drug Substance can preserved by rapid or control-rate freezing.

CMAB can perform full testing for release of Drug Substance in compliance with GMP:

  • General: Visual appearance, physiochemical methods
  • Identity: Peptide mapping, Isoelectric point (typically IEC/IEX/CEX) with option of cIEF or CZE, and optional N-terminal sequencing.
  • Safety: Bacterial endotoxins, bioburden, abnormal toxicity
  • Purity: Chromatography and electrophoresis
  • Strength: Potency Assay, protein quantity
  • Process Impurities: Protein A, host cell protein, host cell DNA
  • Other product-specific tests as requested by our Clients.

ASEPTIC FILLING OF CLINICAL DRUG PRODUCT

CMAB have in-house capability to aseptically fill your Drug Product.

  • Final processing of Drug Substance to Drug Product formulation
  • Filling under Grade A classification with Grade B background
  • Liquid and lyophilized drug products in vials
  • Full validation with media fills
  • Expedited filter compatibility testing with third party testing facilities.

CMAB can perform full testing for release of Drug Product in compliance with GMP:

  • General: Visual appearance, extractable volume, visible and subvisible particles, and physiochemical methods
  • Identity: Peptide mapping, Isoelectric point (typically IEC/IEX/CEX) with option of cIEF or CZE.
  • Safety: Sterility Bacterial endotoxins, bioburden, abnormal toxicity
  • Purity: Chromatography and electrophoresis
  • Strength: Potency Assay, protein quantity
  • Other: Polysorbate
  • Other product-specific tests as requested by our Clients.