Applying lessons from the semiconductor industry to biopharmaceutical production
Semiconductor fabrication and biopharmaceutical production have a solid, shared, objective- to maximize yields through rigorous control of production equipment and process variables.
In Pharmaceutical Technology, Dec. 2019, Gary Daily, VP, Global Marketing, Electronic Materials and Claudia Berrón, Sr. VP, Clinical Services, make the case that 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.
One process variable that the semiconductor industry focuses on is raw material quality.
"Thorough analysis and full characterization of each raw material used will determine the precise composition, down to the parts-per-trillion level, providing information on how this composition might impact the production process."
Biopharmaceutical manufacturers also need to focus on understanding and controlling the characteristics of the materials they use. While materials characterization has been of interest in the biopharmaceutical industry, manufacturers were initially interested in using it to determine stability, rather than yield.
However, in upstream and downstream processes, biopharma manufacturers can correlate raw material data with variations in their bioreactor and process chromatography yields, in order to achieve greater predictability and control of process results. Biopharma producers seeking to improve their process yields have started to assess the impact of stricter and more comprehensive materials characterization in upstream and downstream process steps.
The biopharma industry has improved its trace materials characterization efforts and is applying that data in order to improve upstream and downstream yields. To advance this further, three rigorous processes used in the semiconductor industry can be applied to the biopharma industry: statistical control, analytical capabilities, and in-depth management and control of global supply-chain resources.
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.