Biologics and Biosimilar GMP Release Testing

GMP lot / batch release testing for biologic drug products including biosimilars or monoclonal antibodies for purity, concentration, consistency, identity

GMP lot or batch release testing services for biologic drug substances or drug products are important to ensure the quality control of proteins, monoclonal antibodies (mAbs) or biosimilars. A range of tests are required as part of release testing activities to address the purity, concentration, consistency, identity and biosafety of products.

Our scientists routinely develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Pharmacopeia monographs including USP and Eur. Ph. monographs and test methods.

Intertek's release tests are applied to biosimilars, protein therapeutics, monoclonal antibodies, oligonucleotides and other biotechnology products. Quality control analysis of these complex products is a routine activity in the Intertek cGMP laboratories which are aligned to support both the development and manufacture of biotechnology products.

Biologics release testing services include:

  • Pharmacopeia Monograph Tests
  • Protein purity assay and related proteins (HPLC and Isoelectric Focusing (IEF))
  • Peptide mapping via LC-MS methods
  • Impurities with higher molecular masses (Size Exclusion Chromatography - High performance Liquid Chromatography (SEC-HPLC))
  • Species with differing charge isomers (IE-HPLC)
  • PAGE-gel electrophoresis
  • Protein concentration (A280, Bradford Assay, HPLC)
  • Amino acid analysis
  • Residual contaminant assays
  • Bacterial endotoxins to Eur. Ph. (2.6.14) or USP
  • Host cell protein (HCPs) determination
  • cGMP Cell-based Bioassays
  • Physicochemical properties including appearance, colour, clarity/opalescence pH, particulates, turbidity, extractable volume, osmolality and moisture 

Routine Biosimilar Batch Release Testing Services

Routine biosimilar batch release testing services are available for a range of biosimilar products including a wide range of monoclonal antibody biosimilars:

  • Epoetin α
  • Filgrastim,
  • Insulin
  • Interferons α, β, γ
  • Human Coagulation Factor VII, VIII
  • Somatropin
  • Trastuzumab
  • Interlukin-2

 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
EMEA UK:
+44 161 721 5247
Switzerland:
+41 61 686 4800