Biologics and Biosimilar GMP Release Testing
GMP biologic drug lot or batch release testing services addressing purity, concentration, consistency, identity and biosafety of drug substances or drug products
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. Bringing quality and safety to life, our Total Quality Assurance expertise delivers responsive quality control analysis for complex biologic products from our cGMP laboratories which are aligned to supporting 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
- 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 are available for a range of biosimilar products including a wide range of monoclonal antibody biosimilars:
- Epoetin α
- Interferons α, β, γ
- Human Coagulation Factor VII, VIII