Principal Scientist Merck & Co, Inc Rahway, New Jersey
Continuous manufacturing (CM) has become an emerging production approach for biotherapeutics, which bares benefits including increased productivity, and improved product quality, lower cost of goods. To better support CM process development, process analytical technologies (PAT) have been extensively applied from bioreactor to purification unit operations. Analytical technology transfer (ATT) is needed to enable PAT transfer from development to GMP sites for clinical and commercial material production support. Herein, different categories of PAT will be discussed, including for information only (FIO), in-process monitoring (IPM), in-process control (IPC), and real-time release testing (RTRT). Case studies will be shared for a few of the categories to illustrate PAT applications in CM, as well as the streamlined workflow to transfer PAT to support GMP production.
Learning Objectives:
Upon completion, participants will understand the categories of PAT utilized for process understanding, support and control.
Additionally, audience will be able to understand the streamlined approaches and requirements for PAT to be transferred to clinical and / or commercial sites, dependent on the categories.
Lastly, the future opportunities for PAT will be discussed.