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How Investing in Malvern Instruments Helped KBI Biopharma Find a Clear Commercial Advantage

Dr. Amber Fradkin manages the Particle Characterization Core Facility at KBI Biopharma in Boulder, Colorado. KBI is a biopharmaceutical contract development and manufacturing organization (CDMO) headquartered in Durham, North Carolina, which specializes in accelerating the development of biological therapeutics. KBI’s Particle Core provides specialist particle characterization which is tailored for the (bio)pharmaceutical industry, and includes profiling of particles post IV-infusion, investigation of the kinetics of particle formation, particle identification for forensics applications, API characterization, profiling of particles in drug products for biosimilarity and biocomparability, and assessment of formulation stability, amongst other services. 

The range of samples analyzed and types of studies undertaken by Amber’s team is broad, ranging from parenteral biologics to small molecule topicals, inhalable powders and drug-device compatibility. Differing sample matrices and presentation can create various challenges, not least for KBI’s technology platforms, which often require specialized methods and application experts in order to optimize the quality of the data they collect. KBI is fortunate in that their Particle Core team comprises true experts in their field, with more than 10 years’ experience in developing and perfecting methods for their instruments. Amber says, “This has been very rewarding for us, knowing that we are supplying our clients with the most optimized methods which produce high quality data that helps them better understand their product.” Better product knowledge and understanding leads to better, safer drugs being brought to market much more quickly and cost-efficiently, whilst satisfying all requirements from the FDA and other regulatory agencies.

As our understanding and awareness of the importance and impact of particles in drug products increases, their characterization becomes ever more necessary, both from a perspective of ensuring drug stability, safety and efficacy, and also from the standpoint of meeting regulatory expectations. To support this requirement, analytical instrumentation has advanced significantly over the past decade. “The challenge has been what to do with all of the data these new instruments produce, how to interpret it, how to store it, how to present it in regulatory filings, and so on. With the installation of routine MFI, we started to learn more about the particles in products, and what they look like”, says Amber. “But with this additional information came more questions: ‘Why do these particles look different to those ones? What are they?’“

In the past, Amber’s team generally tried to chemically ID visible particle contaminants solely by methods such as FTIR. But she acknowledges that this was essentially only worrying about the problem when it was already ‘too late’. “Characterizing nanoparticles and subvisible particles early on allows for a much greater understanding of product particle profiles, which can help prevent visible particle formation related to inherent or intrinsic materials. I think of it as being proactive, rather than reactive,” she explains.