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Analytical Development

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 is unified into R&D services. 


Kemwell provides analytical method development and method validation services. Development 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.


The analytical team in support of QC establishes reference standards based on regulatory requirements thorough characterization and comparability establishment. The reference standards are then stored under cGMP conditions.

 

Analytical Development
  • CHO HCP Quantification - ELISA
  • Residual DNA determination
  • Q-PCR & Pico - Green Method
  • Protein A contamination qualification by ELISA
  • Mycoplasma by RT - PCR
  • BET test
  • Kinetic Chromogenic lysate assay
  • Gel clot assay
  • Identity
  • Peptide maping
  • Immuno blotting
  • Electrophoretic techniques
  • Charged variant by CEX & cIEF
  • Size related impurities by SEC, SDS - PAGE (NR) & CE - SDS (NR)
  • Degraded protein by - SDS-PAGE, CE-SDS (NR)
  • Oxidised and reduced impurities by RP - HPLC
  • lgG purity - quantification of free heavy chain and light chain, non glycosylated lgG, Intact lgG and other fragmented species by Capillary Electrophoresis
  • Isoform variant by IEF, CZE and IEF with western blotting 
  • Glycan profiling by Capillary Electrophoresis and UPLC
  • Cell proliferation assays
  • Anti - proliferation assays
  • CDC Complement Depenent Cytotoxicity) assays
  • Cell based cAMP release assay
  • Binding assays
  • Reporter gene assay
  • Compendial methods for parenteral i.e. Sterlity, Endotoxin, Visible and sub visible particulate matter, Degree of coloration and    opalescence
  • Content assays by absorbance, Colorimetric and HPLC based methods
  • Raw material analysis including moisture content, melting point, refractive index, FTIR and various identity and assay methods

    • Lab-scale lyophilizer
    • HPLC and UPLC systems
    • Capillary electrophoresis
    • Micro-plate reader (UV-Vis, Absorbance, Fluorescence)
    • Spectrophotometer

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