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Bispecific Antibodies

A leading technology platform and scientific experience for bispecific antibodies development and production

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Efficient tech transfer for consistent titer and heterodimer/homodimers ratio across the runs from optimization through demonstration to cGMP.

Experience the Power of Integrated Solutions for Bispecific Antibodies


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

In their article, 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.


Delivering on the Promise of Bispecifics

Given the complexity of bsAbs, a  development platform for these needs three key features to be sufficiently robust: Stable and high expression of bsAbs, straightforward early screening, and a robust cell line that can handle stressors. Furthermore, advancing bsAbs into the clinic requires process development, analytical methods, and scale-up for cGMP manufacturing. Our leverageable, integrated workflow generates high-quality clinical bulk drug substances under accelerated timelines.

Article on

Overcoming the Challenges of Bispecific Antibody Production

In a recent article published on, Séverine Fagète, Vice President of Mammalian Cell Line Development at KBI Biopharma, details the innovative and advanced approach she and her team take to overcome common obstacles and bottlenecks in bsAb development and production. KBI Biopharma's strategic approach has been applied to more than 25 bsAbs, yielding up to 99% heterodimers and paving the way for efficient production of bsAbs for clinical use. 


Development of effective purification processes for bispecifics using affinity capture and mix-mode polishing chromatography

Get an inside look at how KBI Biopharma and JSR Life Sciences have developed processes for the purification of bsAbs using Amsphere™ A3 affinity chromatography followed by two polishing steps. Here we discuss the challenges of bispecifics purification and our approach to mixed-mode chromatography designed for bispecifics.


Tuning the Assembly of Bispecific Antibodies by Playing on Differential Polypeptide Chain Molar Ratios

KBI Biopharma’s Mammalian Cell Line Development team recently published the results of their research in Biotechnology and Bioprocess Engineering.  In their article the authors evaluate the impact of manipulating different molar ratios of three polypeptide chains, concluding that by adding gene copies at specific ratios, the expression of bsAbs can be influenced beyond the initial engineering stage.


Streamlined Development For Efficient Production Of Bispecific Molecules Using An Integrated Platform Process

This webinar demonstrates a breakthrough platform approach that encompasses the efficient production of bispecific molecules in an integrated, streamlined way, from CLD (cell line development) to cGMP manufacturing. This integrated process results in high-quality bulk drug substances under accelerated timelines.

Ready to Learn More? Get in Touch with our Team.


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