Analytical Development

KBI's Phase-Specific Lifecycle Approach to Analytics

Analytical Support at Every Phase of the Project Cycle

 

KBI has completed over 3000 analytical projects for more than 100 clients and more than 130 distinct molecules.

Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides, adeno-associated viruses (AAVs), oligonucleotides, and other proteins.

KBI expertise includes HPLC, CE, ELISA, UV-Vis, mass spectrometry, light scattering, biophysical characterization (DSC, CD, FTIR, fluorescence), binding assays (ELISA, Biacore, ForteBio), glycan analyses, cell-based assays, and others.

We routinely provide STAT analytical support for process development and manufacturing (HPLC and other methods for titer, purity, etc.).

KBI employs a phase-specific lifecycle approach to analytics. During method development, the stability-indicating capabilities of methods are evaluated via forced degradation studies. Method parameters are optimized to improve the resolution and recovery of the product-related impurities.

As part of method development, critical performance criteria such as specificity for degradation products (stability-indicating capability), linearity, precision, system suitability, etc., are evaluated. These development data serve as range-finding tools for subsequent protocol-driven qualification and validation studies.

KBI typically performs qualification of non-compendial product-specific methods to demonstrate their suitability for use in release and stability testing of drug substance and drug product intended for Phase I/II clinical studies.

KBI recommends performance of full validation before utilizing methods during process validation/conformance lot manufacture and use of drug substance and drug product for Phase III clinical studies.

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