Analytical

Core Services

  • Internal assay development and testing capabilities include:
    • Identity
    • In vitro bioassays – including cell-based assays
    • Product related impurities
    • Process related impurities
  • Analytical development, testing and support staff of 30
  • Method validation
  • ICH compliant stability testing

Kemwell offers analytical services for recombinant protein therapeutics to support your clinical and commercial product needs. We are equipped with state-of-the art analytical equipment required for routine testing of cell based and non-cell based bioassays for recombinant proteins, including monoclonal antibodies. Our experienced staff possesses in-depth understanding and regulatory knowledge, which can be leveraged to suit your requirements.

Method Development

  • Analytical method development and optimization for various assays including
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  • Identity and purity tests (peptide mapping, western blots, bioassays, etc.)
  • Bioassays (cell based and ELISA based)
  • Product related variants and impurities (SEC, CEX, RP-HPLC, CE-SDS, peptide mapping, etc.)
  • Process related impurities (HCP, HCD, protein A leachates, etc.)
  • Development approach covers all aspects for intended use of the method (stability indicating, process development support, limits of detection/ quantitation, etc.)

Method Validation

  • Based on industry guidelines
  • Extent of validation studies based on stage of product development

Reference Standard Characterization

  • Establishment of reference standards based on regulatory requirements
  • Thorough characterization and comparability establishment
  • Storage under GMP conditions