Bispecifics are asymmetrical molecules that simultaneously recognize two different antigens or epitopes. This multi-functionality is intended to enable development of molecules for multiple clinical applications such as immunotherapies for oncology, or therapeutics for autoimmune and inflammatory disease. However, the structural complexity of bispecific molecules creates manufacturing and analytical challenges in maximizing bispecific yields and facilitating removal and monitoring of byproducts such as homodimers and fragments. We will discuss case studies for two major heterodimerization schemes for bispecific production in Biotherapeutics Pharmaceutical Sciences at Pfizer, and we will show how the corresponding bioprocess and analytical methods are chosen based on unique properties of each molecule.
Learning Objectives:
Upon completion, participants will be able to understand the concept of bispecific molecules.
Upon completion, participants will be able to know about development challenges on the bispecific molecules.
Upon completion, participants will be able to define unique product quality attributes on the bispecific molecules.
