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Analytical Development

OUR EXPERTISE

Kemwell provides analytical method development and method validation services

Kemwell offers analytical services for mammalian cell culture-based products to support your clinical and commercial product needs. Our efficient and strong Analytical Development team’s approach covers all aspects for the intended use of the method (stability indicating, process development support, limits of detection/ quantitation, etc.). The extent of method validation studies are based on the stage of product development and comply with the industry guidelines.

Process Related Impurities and Identity

  • CHO HCP Quantification – ELISA
  • Residual DNA determination
    1. Q-PCR & Pico – Green Method
  • Protein A contamination quantitation
  • Mycoplasma by RT – PCR
  • BET test
    1. Kinetic Chromogenic lysate assay
    2. Gel clot assay
  • Identity
    1. Peptide mapping
    2. Immunoblotting
    3. Electrophoretic techniques
Protein Related Impurities and Variants

Invitro Bioassays

Critical Equipment List

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