Biosimilar Development

Biosimilar product development offers a truly unique set of challenges. Success requires thoughtful, rational planning, extremely strong analytical and biophysical characterization capabilities, and perfect orchestration of resources to meet development milestones. KBI has a proven track record supporting biosimilar product development.

From cell line development to a state of the art mass spectrometry core facility, we have all the capabilities and expertise required to accelerate and advance your biosimilar program. KBI’s scientists already have a deep understanding of the innovator molecules you are considering for biosimilars, so we know the specific challenges to overcome for each product. We have repeatedly designed and executed successful comparability studies in support of filings and are well versed in using multiple lots of innovator product to set ranges to drive process development.

KBI’s extraordinarily strong analytical capabilities make us particularly well-suited for biosimilar development. Through our mass spectrometry core facility, we can provide full sequence verification, post-translational modification assessment, and glycan identification. Our analytical infrastructure goes way beyond the typical quality control instrumentation such as HPLC and CE, and includes biophysical characterization tools, surface plasmon resonance, MFI, microchip analyzers, cell based assays, and more.

The commercial experience of our teams combined with our proven process development capabilities (including full process characterization and design of robust processes that are almost “phase III like” at phase I) allow biosimilar products to move quickly into phase III clinical studies. This reduces the overall development timeline for biosimilar development, allowing clients to meet aggressive launch deadlines. Overall costs are reduced through this approach as well.

KBI’s exceptionally strong analytical capabilities and full range of early and late stage product development services provide exactly the right solutions for biosimilar product development and manufacturing.