Characterization & Consulting

Particle Characterization Core Facility

Modeling & Simulation

Biophysical Characterization

CMC Submissions

Mass Spectrometry Core Facility

Characterization & Consulting

We offer a comprehensive range of analytical, biophysical characterization, mass spectrometry, and modeling and simulation capabilities. KBI’s scientists expertly apply these technologies and and methodologies to interpret the data to deliver the right information needed to support your product through all stages of development as stand-alone consulting services.

KBI has substantial experience in the design and execution of analytical comparability studies. We have executed such studies in support of reference material characterization, manufacturing site changes, and biosimilar-to-innovator comparability, just to name a few. KBI can develop the protocol, perform the analyses, analyze the data, and provide a submission-ready comparability report with all requisite figures and tables.

Our services include:

Whether you are seeking developability data to support proof-of-concept, initial characterization to support IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, KBI offers the experience and instrumentation needed to enhance your understanding of your molecule and accelerate development.

  • Publications & Presentations

    Presentation | Getting Biopharmaceutical Production Processes Right the First Time

  • Publications & Presentations

    Presentation | Quality by Design at a Biopharma CMO