Real-Time Monitoring in Biopharma Forum

Insights from Industry Leaders

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American Association of Pharmaceutical Scientists: Bay Area Discussion Group (BADG)

Speakers

Zhenqi (Pete) Shi

Senior Principal Scientist, Genentech

Dr. Shi started his industrial career at Lilly back in 2011, leveraging his expertise in real-time sensing and modeling on process monitoring, control and optimization on both drug substance and drug product sides to deliver a wide array of therapeutic entities, including small molecule, peptide and monoclonal antibody. In 2021, Dr. Shi joined Genentech, not only serving as an Analytical CMC lead, but also building an early-phase oriented PAT program in its synthetic molecule business. Concurrently, he published over 40 peer-reviewed articles, co-authored multiple book chapters and delivered over 40 presentations on the field of spectroscopy, PAT, chemometrics and RTRt. He has been chairman and organizer for numerous PAT symposia and conferences, such as AAPS and IFPAC. Meanwhile, he has served the PAT subteam lead for the IQ CM DP working group and the co-chair for ASTM E55.01, with the intention to leverage cross-industry influence to foster a sustainable ecosystem for the use of PAT in our industry.

Matt Moran

Senior Associate Development Engineer (Cell Culture), Bayer Pharmaceuticals

Matt has spent his six-year career in the Cell Culture Process Development group at Bayer, applying his chemical engineering background to advance bioprocess development. He has expertise in CHO, T cell, and stem cell culture, with a focus on translating insights and technologies from protein therapeutics to cellular therapies. Having worked with a variety of cell culture and bioreactor platforms at various scales, he enjoys collaborating closely with experts in PAT, data science, and analytics to develop a comprehensive understanding of bioprocesses in real time.

Yang Su

Manager, New Technology & Applications, IDEX MPT Inc.

Dr. Su has been with Microfluidics International Corporation and IDEX MPT since 2012. As the Manager of New Technology and Applications, he focuses on the continued development and promotion of Microfluidics’ cutting-edge Microfluidizer® technology and utilizing his expertise in a wide variety of applications ranging from nanoparticle delivery to cell disruption and more to help pharmaceutical and biotechnology customers with their unique application challenges.

Programs

ZHENQI SHI, SENIOR PRINCIPAL SCIENTIST, GENENTECH

Getting More Eyes On Your Process

The value proposition of Raman Spectroscopy-based PAT for phase-appropriate process development for synthetic molecules

MATT MORAN, SENIOR ASSOCIATE DEVELOPMENT ENGINEER CELL CULTURE, BAYER PHARMACEUTICALS

A Peek Into The Bioreactor

Real-time monitoring of stem cells growth and aggregate morphology using capacitance-based PAT

Yang Su, Manager, New Technology & Applications, IDEX MPT

From Nanoparticle Delivery Platforms to Cell Lysing

A versatile scalable technology serves the biopharma industry with unique capabilities in generating nanoparticle delivery systems as well cell rupturing.

About The Forum

Bringing together those passionate about advancing pharmaceutical science with scientists who are open to sharing their knowledge in operations, science, and education.