Biologic Quality Control and Release Testing

Biologic Quality Control and Release Testing
Product Description

We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists 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 client's test methods. Intertek's release tests are applied to biosimilars, protein therapeutics, monoclonal antibodies, oligonucleotides and other biotechnology products.  Biologics release testing services include: 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.

To learn more, visit our website:

www.intertek.com/pharmaceutical/biopharmaceuticals/release-testing

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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
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Specifications
  • Supplied from
    United Kingdom
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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

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