Multispecific Antibodies and Antibody Fragments
There is an increasing focus in the biopharmaceutical industry on the development of the next generation of complex biologics that allow the targeted delivery of products with multiple functionalities, increasing both efficacy and safety. Bi and multispecific antibodies, antibody fragments and recombinant proteins are prime examples of new drug substances with the potential to offer higher potency with new mechanisms of action and increased safety profile.
The Multispecific Advantage
The interest in bispecific antibodies (and trispecific antibodies) and fusion proteins is driven by their potential to be both more precisely targeted and more potent than conventional mAbs. The close proximity of the binding sites can lead to the formation of new complexes and trigger new cellular contacts. In these cases, the enhancements are greater than if two individual drugs were administered as a combination therapy. With two or more sites for interaction with the target cells, more targeted binding can be achieved and additional immune responses can be activated that involve the T-Cells and natural killer cells, leading to greater targeted cytotoxic effects.
Common Challenges in the Manufacturing of Multispecific Antibodies
The complexity of multispecific antibodies and recombinant protein molecules can create process development and manufacturing challenges both from an expression and process standpoint. These include but are not limited to low product titers, propensity for aggregation, and the potential shift in product quality. Read more about how Goodwin was able to increase product yield by 50% for one of our client’s bispecific antibody projects.
Where Goodwin Shines
Through Goodwin’s vast experience, expertise and flexibility with multivalent antibodies and complex recombinant proteins, we have developed process development and manufacturing platforms that can be applied to de-risk scale-up. Goodwin will partner with you to develop scalable and robust processes for the manufacturing of these challenging biologics.
Our scientific staff at IBC Generium developed GNR‐047, an IgG‐based anti‐CD3/anti CD19 bispecific antibody for the treatment of oncohematological diseases, such as acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and different kinds of non‐Hodgkin’s lymphoma (NHL), and we were looking to partner with a Contract Manufacturing Organization to help us optimize the process and manufacture material to be used in Phase I clinical trials.
We work with a number of companies around the world to advance our portfolio of drug candidates, and one of our primary collaborators highly recommended Goodwin Biotechnology based on the track record they had on a number of their projects that Goodwin Biotechnology had worked on over the last six years.
To learn how Goodwin Biotechnology can help your complex biopharmaceutical candidate.