Applying Lessons Learned from the Semiconductor Industry
Raw materials’ characterization and supply-chain control allow more rigorous control of the manufacturing process.
CLAUDIA BERRÓN AND GARY DAILEY
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.