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 (e.g., DOE sample analysis) 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.
KBI’s Analytical capabilities include:
Protein Primary Structure
- Peptide Sequencing via LC/MS/MS
- Amino Acid Analysis
- Peptide Mapping
Biophysical Characterization
- CD, FTIR, DSC, DLS, MALS, fluorescence spectroscopy
Glycan Analysis
- Oligosaccharide mapping
- Monosaccharide composition
- Sialic Acid Quantitation
HPLC
- Size Exclusion
- Ion Exchange
- Reverse Phase
- Hydrophobic Interaction
- Affinity
Capillary and Slab Gel Electrophoresis
- CZE
- SDS-CGE
- cIEF and icIEF
- SDS-PAGE and IEF
- Western blot
- Microchip electrophoresis
- 2D gels and blots
Process Residuals
- ELISA (HCP, protein A etc.)
- HPLC (antibiotics, IPTG, detergents, etc)
- qPCR (DNA)
Potency Assays
- Enzymatic activity
- Binding Assays via ELISA, Biacore and ForteBio
- Cell Based Assays (e.g., proliferation, cytokine release, etc.)
Particulate Analysis, including <10 micron particle characterization
- HIAC
- MFI
- DLS
Mass Spectrometry
- Intact mass
- Peptide mapping with LC/MS or LC/MS/MS
- Disulfide Mapping
- Post translational modifications (e.g., oxidation, deamidation)
- PEGylation site identification
- Glycan Identification & site identification