Bispecific antibodies (bsAbs) are rapidly emerging as a significant class of biotherapeutics. Unlike monoclonal antibodies (mAbs), which have a single binding site, bsAbs have two distinct binding sites and offer the flexibility of performing multiple mechanisms of action. As a result, this class of therapeutics is experiencing innovations and a marked increase in the number of bsAbs moving from development to the clinic.
The pipeline of bsAb therapeutics is quickly expanding, with the FDA having already approved 10 bsAb therapeutics with more than 100 others currently in clinical trials. In fact, bsAbs now account for nearly 20% of the clinical antibody pipeline1.
With such enormous potential and therapeutic benefit, there are still challenges in developing bsAb-based biotherapeutics, especially in areas like cell line development, production, and purification.
In a recent article published on Labiotech.eu, 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.
For more details and insights into KBI Biopharma's novel approach to effective and efficient bispecific antibody production, you can read the full article at Labiotech.eu:
These complex bsAb molecules require a special focus on engineering and specific optimization throughout the development and manufacturing process, prioritizing quality, efficiencies, and time savings in bsAb production and purification to capitalize on their incredible therapeutic potential.
KBI Biopharma’s Mammalian Cell Line Development team at our Geneva, Switzerland location recently published the results of their research in Biotechnology and Bioprocess Engineering. In their article Tuning the Assembly of Bispecific Antibodies by Playing on Differential Polypeptide Chain Molar Ratios, 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 stage2.
Our mammalian-based bispecific expression combines best-in-class cell line development with unmatched expertise and experience in mammalian-based contract development and manufacturing across a diverse portfolio of molecule formats. Learn more about KBI Biopharma’s solutions for bispecifics to jump-start your program today.
1. Boronowsky, Ute. Can we overcome the challenges of bispecific antibody production? Labiotech, 17 October 2023. https://www.labiotech.eu/partner/bispecific-antibody-production
2. De Temmerman, C., Bernard, P., Aeberli, Q. et al. Tuning the Assembly of Bispecific Antibodies by Playing on Differential Polypeptide Chain Molar Ratios. Biotechnol Bioproc E (2023). https://doi.org/10.1007/s12257-023-0057-9