Integrated Solutions for Bispecific Antibodies
A Breakthrough Platform Approach for the Efficient Development and Manufacturing of Bispecific Antibodies
Our vertically-integrated development and manufacturing platform builds upon in-depth comprehension of bispecific antibodies particularities to ensure efficient, high-quality bispecific antibody protein expression from cell line development (CLD) through to cGMP 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 novel or 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 at once.
Our seamless approach to bispecific antibody production optimizes your experience, delivering high-quality bulk drug substances under accelerated timelines.
World-Class Expertise in Bispecific Antibody Protein Expression and Cell Line Development
While many of the bispecific antibodies in development fundamentally maintain the heavy and light chain structure of standard antibodies, advances in protein engineering have allowed for the bispecific antibody protein expression and cell line 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. We have wide-ranging bispecific antibody protein expression and cell line development experience in Hc/Lc classical formats, BiTEs, DARTs, and appended domains.
Industry-Leading Delivery of Bispecific Antibody Programs Through Increased Quality, Efficiency, and Time Savings.
Our mammalian-based bispecific antibody development and manufacturing solutions combine best-in-class CLD with unmatched expertise and experience in mammalian-based contract development and manufacturing. We prioritize quality, efficiencies, and time savings in bispecific antibody protein expression and cell line development across a diverse panel of bispecific 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. The stress typically induced in cells expressing bispecific antibodies usually leads to insufficient productivity. Our SURE CHO-M Cell Line has proven its robustness in this regard.
- Stable and high expression of the proteins of interest which, in the case of bispecific antibodies, often means playing with molar ratios of light and heavy chains to maximize the heterodimer/homodimer ratio toward the correct dimer pairing.
- 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 cGMP.
