Analytical Development

Analytical Development

Biopharmaceutical Analysis

Kemwell Biopharma offers platformbased analytical services for recombinant therapeutics to support your development and marketed-product needs. We are equipped with state-of-the art analytical equipment required for routine testing, complete characterization of recombinant proteins, including monoclonal antibodies. Our experienced staff possess an in-depth understanding and regulatory knowledge, which can be leveraged to suit the client’s requirements. We provide quality services and data at significantly lower costs, as compared to labs in the US and western Europe.

Analytical Services:
  • Analytical method development, optimization, qualification, validation and comparability studies.
  • Master / Working / Analytical Cell Bank preparation, Characterization and storage.
  • Reference standard establishment and storage.
  • Stability management.
  • Product characterization.
  • Impurity profiling and related forced degradation studies.
Analytical capabilities:
  • In vitro bioassays:
    1. Cell proliferation assays
    2. Anti-proliferation assays
    3. Antibody Dependent Cell mediated Cytotoxicity (ADCC) assays
    4. Cell Based cAMP Release Assay
    5. Reporter Gene Assay
  • Glycan profile characterization:
    1. Capillary Zonal Electrophoresis (CZE) with Fluorescent detector
    2. UPLC with Fluorescent detector
    3. HPLC with Fluorescent detector
  • Product Related Impurities:
    1. Charge related impurities- by Ion exchange chromatography
    2. Size related impurities- by SEC and Non-reducing SDS-PAGE
    3. Degraded protein- by reducing SDS-PAGE
    4. Oxidized and reduced impurities- by RP-HPLC
    5. Isoform variant- by CZE, IEF and IEF western blot
  • Process related impurities:
    1. Host Cell Protein by ELISA
    2. Host cell DNA by
      1. RT-PCR
      2. Pico green method
    3. Protein A by HPLC
  • Identity:
    1. Peptide mapping
    2. CZE
    3. RP-HPLC
    4. SEC
    5. IEC
    6. Immunoblot
    7. SDS-PAGE (Reducing and non-reducing)
  • Protein Quantification:
    1. Absorbance at 280 nm
    2. Absorbance at 280 nm with light scattering
    3. RP-HPLC
    4. Calorimetric assays e.g. Bradford, lowry, BCA etc.
  • Capillary Electrophoresis:
    1. Capillary Gel electrophoresis (CGE)
    2. Capillary Iso Electric focusing (CIEF)
    3. Capillary Zonal electrophoresis (CZE)
  • Microbiology related analysis:
    1. Bioburden
    2. Sterility
    3. BET
  • Miscellaneous
    1. Excipient analysis
    2. General characteristics of finished products e.g. Sub visible particle determination, degree of coloration and opalescence etc.
    3. Agarose gel electrophoresis, quantification of Nucleic acid, restriction digestion, competent cell preparation, transformation, selection of clones, expression of gene of interest etc.