Application of platform process development approaches to the manufacturing of Mabcalin™ bispecifics

Journal of Biotechnology
Volume 377, Pages 13-22
20 November 2023

 https://doi.org/10.1016/j.jbiotec.2023.10.003

KBI Biopharma’s Process Development team at our Durham, North Carolina location, together with colleagues from Pieris Pharmaceuticals, recently published the results of their research in the Journal of Biotechnology.  

There is a growing global need for robust bispecific antibody (bsAb) development, as bsAbs encompass one of the most promising, proven classes of therapeutics recently reaching the market. This is due to their ability to bind to two different epitopes and offer the flexibility of performing multiple mechanisms of action. However, challenges arise in the fact that numerous bispecific formats often face the issue of significant aggregation and instability, which can result in delays in the development process, inefficient manufacturing, and excessive cost.

In their article Application of platform process development approaches to the manufacturing of Mabcalin™ bispecifics, the authors evaluate a high-yield manufacturing platform using Mabcalcin™ molecules (which consist of Anticalcin^® proteins fused to an IgG), assessed to commercially-relevant scales¹.  This platform approach demonstrates a fast, optimized route to process confirmation that aligns  with classical monoclonal antibody (mAb) approaches when it comes to timelines and overall cost.

Read the Article on ScienceDirect >>

Learn More about Bispecific Antibody Production at KBI Biopharma 

At KBI Biopharma, we've mastered the art and science of bsAbs. Following our operational consolidation with Selexis SA, we possess a combined proven track record of innovative solutions supercharged by the KBI Biopharma SUREtechnology Platform™, powered by Selexis^®. 

Our fully integrated development platform encompasses a strong understanding and efficient production of bispecific antibodies from cell line development (CLD) through GMP commercial manufacturing. Our seamless approach optimizes your experience, delivering high-quality bulk drug substances under accelerated timelines. At KBI Biopharma, we don't just focus on one aspect of bispecific antibody production — we address challenges in cell line development, production, purification, and manufacturability. 

Learn more about KBI Biopharma’s solutions for bispecifics to jump-start your program today.  

1. Stefanie Wachter, Thibaut Angevin, Niket Bubna, Adelene Tan, Adam Cichy, David Brown, Leslie S. Wolfe, Ryan Sappington, Edward Lilla, Luke Berry, Dane Grismer, Christian Orth, Milan Blanusa, Sigma Mostafa, Hitto Kaufmann, Karin Felderer. Application of platform process development approaches to the manufacturing of Mabcalin™ bispecifics. Journal of Biotechnology, Volume 377, 2023, Pages 13-22, ISSN 0168-1656. https://doi.org/10.1016/j.jbiotec.2023.10.003.
(https://www.sciencedirect.com/science/article/pii/S016816562300175X)