Applying Lessons Learned from the Semiconductor Industry
Raw materials’ characterization and supply-chain control allow more rigorous control of the manufacturing process.
Two of the world’s most complex manufacturing industries—semiconductor fabrication and biopharmaceutical production—share a common fundamental objective: to maximize process yields through rigorous control of production equipment and process variables.
One process variable that the semiconductor industry has long focused on is raw material quality. Thorough analysis and full characterization of each raw material used will determine the precise composition, down to the parts-pertrillion level, providing information on how this composition might impact the production process.
Recently, biopharmaceutical manufacturers have also begun to focus on understanding and controlling the characteristics of the materials they use. In upstream and downstream processes, biopharma manufacturers seek to correlate raw material data with variations in their bioreactor and process chromatography yields, with a goal of achieving greater predictability and control of process results.
In formulation, a lot of emphasis goes into correlating how variables in excipients affect drug product stability (and therefore bioavailability) throughout the shelf life of the product. There is significant value in assessing and potentially applying the semiconductor industry’s highly developed advanced materials analysis, characterization, and supply-chain control practices to materials’ management and process control issues in biopharmaceutical operations.
Authors
Claudia Berrón
Senior Vice President, Clinical Services
Claudia Berrón is Avantor’s Senior Vice President, Clinical Services. Prior to this, she was Senior Vice President, Business Development and Commercial Operations for our Biopharma Production business unit. Claudia has over two decades of experience in strategic marketing, covering ideation, value proposition strategies, market segmentation and planning through product and services launch into market. She has been with Avantor since 2015.
Claudia holds an MBA from the University of North Carolina Kenan-Flagler Business School and a bachelor’s degree from Monterrey Institute of Technology in Mexico City.
Gary Dailey
Gary Dailey joined Avantor (then called J.T.Baker Chemical Company) in 1984 as an Research and Development technician, later serving as a senior research chemist, applications engineer and Quality Control manager. Since shifting to the sales and marketing operation of the EM business, Dailey has held various positions of increasing responsibility, leading to his current role as Global Business Leader. Dailey oversees product and strategic marketing activities for Avantor’s EM business, supporting electronics manufacturing worldwide.
Dailey received a BS in Biochemistry from Lock Haven University. He is based in Center Valley, PA