KBI Logo Method Development

Robust methods for characterization, stability and release.
 

KBI headquartersAnalytical Method Development

High-quality analytical development is essential to the success of any drug development effort. Our capabilities enable the characterization of the drug for all of the required attributes:

 

• identity
• purity
• strength
• potency
• safety

 

 

We are experts in the development, validation and transfer of analytical methods – be it a “stand-alone” method that provides a key piece of information in a project, or an integrated suite of methods for support of a comprehensive development project.

 

We deliver robust analytical methods that are either fully validated or validation-ready and easily transferable. Each method is accompanied by a method development report and a validation report that are ready for inclusion in a CMC section of your regulatory submission.

 

Our Analytical Portfolio

Primary structure

Peptide Sequencing via LC/MS/MS, Amino Acid Analysis, Peptide Mapping
Carbohydrate Analysis HPLC (post derivitization), HPAE Chromatography, Peptide/ Carbohydrate mapping
Aggregation, Degradation DLS, SDS-PAGE, SEC-HPLC, SEC-MALS, Spectroscopy, Mass Spectrometry
Chemical Modification CE, RP-HPLC, HIC-HPLC, IEX-HPLC, Peptide mapping
Biophysical Characterization DLS, Secondary structure - CD, FTIR
Tertiary structure, conformational stability -
CD, Ultra sensitive DSC, fluorescence spectroscopy
Mol. Weight & Shape DLS, Mass Spectrometry (ESI-TOF), HPLC-MALS
Biological Activity Biacore, Immunoassays, Binding assays, Cell-based Bioassays
Extinction Coefficient Amino Acid Analysis via GC/MS
Routine Testing ICH Stability, Release, Specification Development.
Appearance, pH, Osmolality, Karl Fisher, Viscosity, Particulates


Bioassay Development

The complex structure of biotherapeutic drugs translates into complexity of biotherapeutic function. In an effort to accurately capture the subtle functional changes for a biotherapeutic, bioassays are applied at many stages in the drug development pipeline – including target discovery, lead optimization, pre-clinical development and as potency assays for batch release.

 

There are so many subtle factors involved in bioassay development, so we rely on our broad experience base and pay close attention to detail in the development and validation of bioassays for our client’s products.