Putting Science to Work
Analytical Methods: Development & Validation

Method Development/Validation

Analytical Methods: Development & Validation

Syngene has hands-on experience to develop and optimize methods at our cGMP compliant analytical facilities, equipped with an array of tools and techniques. Syngene can also support analytical method validation as per ICH guidelines (ICH Q2R1) and can cater to any client-specific needs.

Our capabilities include:

Analytical Method Development

  • Small Molecules
    • Purity analysis by HPLC, UPLC and GC
    • Reaction monitoring using UPLC-MS and GC-MS
    • Quantitative NMR analysis
    • Potency
    • Impurities - Residual solvents and organic impurities
    • Physical and chemical tests
    • Cleaning assessment
    • Chiral purity
    • Others as requested               

  • Biologics (Biochemical and biological analysis and characterization)
    • Bioassays: Potency by In-vitro cell based and non-cell based assays
    • Analysis of impurities and variants
      • Related proteins by RP-HPLC
      • Charge heterogeneity and isoforms by IEX, cIEF
      • Slab gel electrophoresis & Capillary electrophoresis (CE) - CGE, CZE, IEF
      • Imaged Capillary Electrophoresis- IEF (iCE 280)
      • Aggregate quantitation by SEC, DLS
      • SDS-PAGE, Capillary gel electrophoresis

      • Process impurities
        • Host cell DNA
        • Host cell protein
        • Residual Protein-A
        • Residual process additives

      • Structural characterization
        • Identity of protein by Mass spectrometry
        • Glycoform analysis
        • PTM analysis
        • Glycosylation site determination
        • Peptide mass fingerprinting and amino acid sequencing
        • Secondary and higher order structure by CD, fluorescence

    Analytical Method Validation
      • Chromatographic method validation
      • Non-chromatographic method validation
      • Immunological assays validation
      • Bioassay validation

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