GMP Implementation of Continuous Manufacturing: A case study

18th April 2023 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Neil Soice, Executive Director, Drug Substance Technologies at Amgen, Inc. and Michael Phillips, BioContinuum™ Platform Director at Merck |WATCH FOR FREE

Continuous processing is being explored in various ways throughout the biopharmaceutical industry. New process technologies and business considerations are driving process design towards more agile, modular, and highly productive paradigms. Continuous manufacturing provides potential benefits such as reduced process scale and the implementation of single-use technologies. However, these benefits may come at the cost of complexity. This presentation will review a case study analyzing the conversion of a traditional GMP process into a continuous manufacturing paradigm. The discussion will include the development of integrated continuous operations, control strategies, and process design considerations. The outcomes of the process conversion will also be discussed.

Presented by Neil Soice, Executive Director, Drug Substance Technologies at Amgen, Inc.

Neil Soice, Exectutive Director, Drug Substance Technologies at Amgen, Inc. GMP Implementation of Continuous Manufacturing: A case study — Neil has been at Amgen for 9 years, currently leading the Drug Substance Technology and Engineering organization, which is responsible for technology transfer, process validation, and manufacturing and regulatory support to enable Amgen’s clinical and commercial production. Previously, Neil led early-stage upstream and downstream process development. He has also led Amgen’s continuous manufacturing technology and process development efforts for many years. Neil has a Ph.D. in chemistry from the University of Colorado at Boulder. Neil started his industrial career at Millipore, where he developed diagnostic and bioprocess membranes, chromatography resins, and depth filters.

Michael Phillips, BioContinuum™ Platform Director, Merck

Mike has been with Merck for over 30 years, with a continual focus on biomanufacturing innovation. Mike is currently a Technical Director within the BioContinuum™ Platform team focused on identifying, developing, and implementing innovative upstream and downstream processing technologies, novel process analytical technologies and sensors, and advanced software and automation that enable intensification for mAb processing, including integrated, connected, and continuous manufacturing. Mike is also actively involved in industry consortia and strategic collaborations focused on developing and delivering next generation biomanufacturing processes and facilities. Mike received his Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute.

Sponsored by Merck

Merck is a multinational leading science and technology company based in Darmstadt, Germany and active in 66 countries in 3 business sectors: Healthcare, Life Science and Electronics. Our comprehensive Life Science portfolio supports customers during all stages of the drug manufacturing process. We offer a broad range of products and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and automation, control and analytics software helping you get to clinic faster, and delivering safe, effective therapies sooner to the patients that need them most.

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