QC release testing of biopharmaceutical products

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QC release testing of biopharmaceutical products

The emergence of increasing numbers of biotechnology-derived pharmaceuticals has led to the development of a set of specialized tests and assays to determine the identity, quality, purity and potency of this class of drug

Almac has a long-standing status as a center of excellence for pharmaceutical release testing to the highest level of cGMP compliance. This enables us to develop and validate analytical methods, work from pharmacoepial methods and design & execute validation protocols for client methods were appropriate.

Our biopharmaceutical release testing services:

  • General pharmacopoeial tests including appearance, osmolarity, pH, etc.
  • HPLC assay for purity assessment and related proteins
  • Isoelectric Focusing (IEF) for charge heterogeneity analysis
  • Peptide mapping using chromatographic, gel electrophoresis and LC-MS methods
  • Size Exclusion Chromatography (SEC) for aggregate analysis and molecular size
  • Gel electrophoresis (SDS-PAGE; native PAGE; Gel IEF; 2-D PAGE)
  • Protein concentration (Folin-Lowry; Bradford; BCA; UV determination; Kjeldahl method)
  • Amino acid analysis
  • Process-related impurity screening
  • Bacterial endotoxins (gel clot method)
  • Host cell protein (HCPs) determination – multiplex ELISA
  • cGMP Cell-based Bioassays (through our cGMP-accredited partners)
  • PK/PD analysis using a validated ELISA for the test biologic
  • A parallel study using an ELISA for detection of antibodies raised in the patient against the drug (anti-drug antibodies, or ADA’s)

Additional methods may be available upon client request.

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