Biologics and Biosimilar Product Release Testing
Release testing is important for both bulk lots and the finished biopharmaceutical product. Release testing addresses the criteria of: purity, concentration, consistency, identity and biosafety.
Release testing is important for both bulk lots and the finished biopharmaceutical product. Intertek's suite of release tests includes analytical characterisation, potency, endotoxin and bioburden testing.
Intertek can develop and validate methods or perform technology transfer from the Sponsor for the various analytical methods required for lot release criteria. Intertek also routinely carry out Pharmacopeia monographs including USP, Eur. Ph., for a range of protein APIs. Intertek's suite of release tests are applied to biosimilars, protein therapeutics and monoclonal antibodies.
Routine Release testing services include:
- Pharmacopeia Monograph Tests
- Protein assay and related proteins(HPLC and IEF)
- Peptide maps via LC-MS methods
- Impurities with higher molecular masses (SE-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 Eur Ph (2.6.14) or USP
- Host Cell Protein (HCPs) Determination
- cGMP Cell-based Bioassays
Routine Biosimilar Release Testing Services
Routine Biosimilar testing services include Release testing for a range of common biosimilars including these
- Epoetin α
- Filgrastim,
- Insulin
- Interferons α, β, γ
- Human Coagulation Factor VII, VIII
- Somatropin
- Trastuzumab
- Interlukin-2
Biopharmaceutical Services:
Request more information to see how Intertek can help your organization with Biologics and Biosimilar Product Release Testing.