Bioprocess Design and Operation: Enhanced Bioreactor Observability and Process Guidance

Biopharmaceutical companies are continually striving to fundamentally understand and optimize cellular performance within their bioreactors. While on-line process analytical technology (PAT) tools like dielectric and Raman spectroscopy are helping to provide insight into cell processes that impact titer and antibody quality, the integration of these data with off-line measurements such as cell density, viability, and titer remains an elusive goal.

Bend Research Inc., in collaboration with Pfizer Inc. and other major biopharmaceutical companies, is working to advance the Modular Automated Sampling Technology (MAST^TM) and automated data retrieval and analysis platforms. The goal of these systems is to provide a data generation and management solution to the end user that includes aseptically collected bioreactor samples delivered to multiple analytical devices and a graphical user interface (GUI) for real-time data analysis and predictive model development. Early studies with the MAST sample delivery system coupled with our data-processing software effectively allows better system observability and real-time process understanding for the end user.

This presentation describes how Bend Research has created an integrated lab environment that capitalizes on the MAST platform to collect high density data sets for on-line analysis and predictive model generation.

We will describe how real time data generation and visualization tools are being used to monitor bioreactor processes in order to enhance cell line and process understanding for research scientists.

From this new level of insight into the bioreactor, scientists can obtain enhanced data-driven guidance for key activities like enhanced process understanding and optimized process operation. With this new technology, the bioprocess industry can make major advances toward advanced real-time testing, predictive control, and overall enhanced bioprocess design and operation.

Speakers

Clint Pepper, Ph.D., Director, Bend Research, a division of Capsugel Dosage Form Solutions

Clint Pepper, a Director at Bend Research, a division of Capsugel Dosage Form Solutions, is responsible for the development and delivery of novel engineering technologies for the Pharmaceutical industry, particularly for biotherapeutics applications. Currently, he is one of the leads on the advancement of the Modular Automated Sampling Technology™ (MAST) platform, which enables optimized sampling of media, cell, and product information across numerous scales in bioreactors with hands-off, contamination-free sampling, automated sample scheduling, and automated at-line analysis.

Dr. Pepper received a B.S. degree in chemical engineering from Washington State University and M.S. and Ph.D. degrees in chemical engineering from UCLA. Prior to joining Bend Research in March 2013, he spent 20 years in the bioPharmaceutical and medical-device industries for such companies as Xoma, SkyePharma and HemCon Medical Technologies. Dr. Pepper is president emeritus of the San Diego chapter of the International Society of Pharmaceutical Engineering (ISPE) and served on the ISPE Board of Directors as vice president of the Northwest chapter.

Message Presenter

Jeffrey Breit, Ph.D., Director, Bend Research, division of Capsugel Dosage Form Solutions

Jeffrey Breit is a Director at Bend Research, a division of Capsugel Dosage Form Solutions, where he works in the fields of biotherapeutic drug development, inhalation drug delivery and formulation technologies. He has worked at Bend Research for 7 years.

Dr. Breit earned his Ph.D. in Pharmacology from the University of South Alabama, while working in the Center for Lung Biology. His doctoral work focused on defining genetic and molecular signaling processes involved in pulmonary disease. Dr. Breit performed his postdoctoral work at Roche Pharmaceuticals in Palo Alto, California, where he researched the genetics of complex disease states.

Message Presenter