The modular nature of the IgG protein scaffold has been exploited to design therapeutic antibodies with many new and innovative formats. As promising as these new formats are in terms of providing new therapeutic mechanisms, the development of such molecules into safe and effective drugs presents unique challenges. This talk will focus on the ongoing efforts to understand and address the challenges of bispecific antibody manufacturing from the perspective of analytical development and quality control. In particular, the focus will be on the ongoing characterization of unique product-related variants related to knob-in-hole bispecific antibodies and their assembly. We are using a variety of techniques to get a better understanding of knob-in-hole assembly variants, both in terms of their structure as well as their behavior in our processes, analytical methods and products. Ultimately, improved understanding will contribute to more effective new medicines with enhanced manufacturability, product quality and safety.

Characterization of knob-in-hole assembly variants in support of bispecific antibody development

251st National Meeting (2016)

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