Application Of Process Analytical Technology (PAT) In The Antibody-Drug Conjugate (ADC) Bioconjugation Process

By Haowei Song, Yiyi Li, Kim Nguyen, Jake Spikes, Mary Ramisetty, Gang Yao, and Lisa MacDermott, MilliporeSigma

While Process Analytical Technology (PAT) offers significant advantages, integrating it into an existing, validated Good Manufacturing Practice (GMP) process can be intricate and sometimes costly. The complexity arises from the need to ensure that the new PAT equipment does not compromise the validated status of the process. Additionally, validating the cleaning process for complex PAT equipment can be particularly challenging if single-use options are not feasible. This is because the equipment often involves a combination of analytical instruments, manufacturing machinery, and automation systems, each requiring thorough validation. Method qualification within a GMP setting presents similar challenges. PAT systems typically consist of a hybrid of various components, which include analytical instruments, manufacturing equipment, and automation systems.

This white paper delves into the application of PAT to achieve a comprehensive understanding of the bioconjugation step in the production of antibody-drug conjugates (ADCs). By employing PAT, manufacturers can better characterize ADCs and other bioconjugate products to ensure higher quality and consistency.

Access the full white paper to learn more.