Webinar

The bioconjugate field is undergoing rapid evolution, and the development of new bioconjugate structures requires intricate, multifaceted approaches that encompass carrier molecules, linkers, and small molecule drugs. This complexity presents significant challenges in the analytical development of bioconjugates, including the need to assess linker-payload stability, conjugation heterogeneity (in terms of site and ratio), and process-related impurities, as well as to develop specialized assays to monitor the conjugation process. Moreover, a critical aspect is the efficient development of analytical methods tailored to the diversity of bioconjugates.
 
This presentation delves into the development of physicochemical and biochemical analysis methods for various types of bioconjugates, presenting an integrated analytical strategy to address development hurdles and accelerate the CMC timeline.

 
Key Learning Objectives:

• The critical quality attributes (CQAs) to monitor during process development
• Learning strategies to overcome these challenges.
• Case studies for various physicochemical and biochemical methods
• Mass spectrometry application in PD support and product characterization
• WuXi XDC’s integrated analytical platform for bioconjugate CMC development

Speaker:
 

Dr. Zhiguo Li
Executive Director
WuXi XDC