Process analytical Technology for Upstream Bioprocessing


05th March 2018 | 10 AM EST | Dr Erica Fratz-Berilla & Dr Stuart Tindal |WATCH THIS FREE ON DEMAND WEBINAR

In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.

Presented by Erica Fratz-Berilla & Cyrus Agarabi

Erica Fratz-Berilla leads the cell culture team of upstream bioprocessing within FDA CDER’s Office of Biotechnology Products, Division of Biotechnology Review and Research II. Previously, she was an ORISE fellow in FDA CDER’s Office of Testing and Research working in upstream and downstream bioprocessing. She has experience in cell culture, small-scale bioreactor operation, perfusion technologies, and protein purification. Erica has a B.S. in biochemistry from Lehigh University and a Ph.D. in Medical Sciences from University of South Florida.

Sponsored by Sartorius Stedim Biotech

 

Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1,052 million euros.

Presented by Stuart Tindal

Stuart is an organic chemist come biochemical process engineer and PAT subject matter expert for the bioprocess industry. He is from Scotland but has relocated to other European countries over the past few years and is now currently residing in Goettingen Germany. Stuart has worked in the technical and commercial field of bioprocess technology for the past 11 years. He gained 5.5 years’ technical marketing experience in single-use sensors and process analytical technologies while working as a Product Manager for Sartorius Stedim Biotech GmbH. Prior to that, 5 years of biochemical engineering experience in form of a process development scientist and biochemical engineering doctorate work.


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