KBI's Phase-specific Lifecycle Approach to Analytics

KBI has successfully completed over 300 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 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, Forte Bio), 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 resolution and recovery of the product-related impurities.

As part of method development, key 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 in order 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 that full validation be performed prior to utilizing methods during process validation / conformance lot manufacture and use of drug substance and drug product for Phase III clinical studies.

Analytical KBI (click to enlarge)

KBI’s Analytical Capabilities

Protein Primary Structure

  • Peptide Sequencing via LC/MS/MS

  • Peptide Mapping

  • Amino Acid Analysis

Biophysical Characterization

  • CD, FTIR, DSC, DLS, MALS, fluorescence spectroscopy, 2DUV

Glycan Analysis

  • Oligosaccharide mapping

  • Sialic Acid Quantitation

  • Monosaccharide composition

HPLC/UPLC

  • Size Exclusion

  • Reverse Phase

  • Affinity

  • Ion Exchange

  • Hydrophobic Interaction

Capillary & Slab Gel Electrophoresis

  • CZE

  • cIEF and icIEF

  • Western blot

  • 2D gels and blots

  • SDS-CGE

  • SDS-PAGE and IEF

  • Microchip electrophoresis

Process Residuals

  • ELISA (HCP, protein A etc.)

  • qPCR (DNA)

  • HPLC (antibiotics, IPTG, detergents, etc)

Potency Assays

  • Enzymatic activity

  • Cell Based Assays (e.g., proliferation, cytokine release, etc.)

  • Binding Assays via ELISA, Biacore and ForteBio

Particulate Analysis, Including <10 micron Particle Characterization

  • HIAC

  • DLS

  • MFI

  • Morphologi G3-ID

Mass Spectrometry

  • Intact mass

  • Disulfide Mapping

  • PEGylation site identification

  • Peptide mapping with LC/MS or LC/MS/MS

  • Post translational modifications (e.g., oxidation, deamidation)

  • Glycan Identification & site identification