Integrated Solutions for Bispecific Antibodies
A Breakthrough Platform Approach for the Efficient Development and Manufacturing of Bispecific Antibodies
Our fully-integrated development platform encompasses a strong understanding and efficient production of bispecific antibodies from cell line development (CLD) through to GMP commercial manufacturing.
There is a global need for high-quality, effective, off-the-shelf therapies that can be used immediately while concurrently avoiding supply chain issues and mitigating process complexities. An off-the-shelf therapy that can be used immediately, rather than one that is manufactured individually for each patient, can be a life-saving proposition for patients facing difficult-to-treat diseases. Bispecific antibodies (bsAbs) are constructed to help meet this need due to their ability to bind to two or more different epitopes, thereby allowing them to perform multiple discrete mechanisms of action.
Our seamless approach optimizes your experience, delivering high-quality bulk drug substances under accelerated timelines.
World-Class Expertise in Bispecifics
While many of the bsAbs in development fundamentally maintain the heavy and light chain structure of standard antibodies, advances in protein engineering have allowed for the development of smaller versions, such as BiTEs and DARTs, and for more complex versions with extra binding domains appended to the heavy and/or light chains of the antibodies. KBI has experience in classical formats of Hc/Lc in bsAbs as well as BiTEs and DARTs and appended domains.
Industry-Leading Delivery of Bispecific Programs Through Increased Quality, Efficiency, and Time Savings.
Our mammalian-based bispecific expression combines of best-in-class CLD with unmatched expertise and experience in mammalian-based contract development and manufacturing. We prioritize quality, efficiencies, and time savings in bsAb production across a diverse portfolio of molecule formats. KBI's solutions for bispecifics encompass the five key features that you should be looking for when developing your bsAbs program:
- Robust cell line to cope with expression stress resulting from translating, folding, and pairing such complex, non-natural proteins leading to insufficient productivity
- Stable and high expression of the proteins of interest which, in the case of bsAbs, often means playing with molar ratios of light and heavy chains to enhance the heterodimer/homodimer ratio
- Straightforward approach to early screening for cell clones producing the highest levels of intact heterodimer, which typically requires screening of pools transfected with a matrixed panel of different heavy and light chain ratios
- Comprehensive analytical science offering, especially regarding assays to investigate product fragments, charge heterogeneity, and impurities, which are typical to measure homodimer and heterodimer levels, a key component of bispecific development
- Efficient tech transfer for consistent titer and heterodimer/homodimers ratio across the runs from optimization through demonstration to GMP
