With beers and wood-fired pizza in hand, Spring BioBeer attendees sat down to an informal presentation by Dr. Aaron Kessman, Lead Scientist for Process Development at MT, in Pizza44's event room. Dr. Kessman was presenting on "Real Time Analysis to Continuously Measure Critical Material Attributes During Biopharmaceutical Manufacture," an important quality control topic for biopharmaceutical manufacturing processes. Specifically, Dr. Kessman explained how he ensures uniform real-time product quality during development and commercial continuous manufacture.
This product is manufactured continuously in real time, consequently the manufacture process is faced with a critical challenge: how can the process ensure that the active drug ingredient is precisely consistent throughout the entire manufacture process, ensuring every patient receives the correct dose.
The company wanted a way to monitor and correct the quality of the coating in real-time without interfering with their continuous manufacturing process. This resulted in the development of real-time at-line spectral imaging.
Dr. Kessman explained that their strategy for handling the spectral data has been to use extensive computational analysis, including multivariate regression, de-noising filters, and baseline removal. He's able to process both spatial and spectral information, revealing where drug concentrations are high or low.
As part of Dr. Kessman's data analysis work, he has designed validated spreadsheets for manufacturing operators. The spreadsheets need minimal inputs from operators, with many functions automated, and do all the complex calculations behind the scenes. This strategy for spreadsheet management protects data integrity with little burden on operators while giving clear quality control feedback, allowing operators to react in real time to prevent any of the coating going out of spec.
Using commercial product as a case study, Dr. Kessman's talk presented BioBeer attendees the opportunity to think about an interesting biopharmaceutical process challenge and the solutions that he and his company have developed.
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