Charlotte Pushparajan
Student: I am a 3rd year student of Biochemical Engineering. I took the extra mural year option to work for a year at Lonza Biologics, Slough. Company: Lonza Biologics is a leading custom manufacturer for the life sciences which can offer a complete drug development package from cell line construction to cGMP manufacture up to volumes of 20000L including a range of analytical services and regulatory support for clinical trials.
Background: After completing large-scale bioprocess studies during the 'pilot plant week' in my 2nd year at UCL, I was excited to see the translation of how whole bioprocess works in industry. The area of research I was involved in was process validation. I performed shake flask cell culture experiments for the validation of cell culture media and feeds.
The challenge: The inconsistencies in the expiries of similarly formulated feeds brought to light the need to standardize their expiries. I evaluated the extension of the current expiry of the SFA nutrient feed used in Lonza's generic manufacturing processes from 7 days to 14 days to the end of feed application with the time from completion of filtration to bioreactor feed initiation not exceeding 72 hours.
Issues that arose were: The apparent issue in the validation process was the need to ensure the comparability of growth, productivity and product quality data from fed batch fermentations run using the SFA feed which was 7 days and 14 days old on its last day of use respectively, and ensuring process robustness by testing with multiple cell lines. It was found that a new expiry of 14 days was acceptable for the SFA nutrient feed.
Result: I feel that I am now equipped to benefit from the university courses on validation and my practical experience helps me design better process flowsheets on my bioprocess design project module.
The company now has extended the SFA feed expiry to 14 days to the end of feed application for its generic manufacturing processes and this has permitted the enhanced operability of manufacturing projects requiring SFA to be fed for durations longer than 7 days, reducing labour and costs that previously went into preparing multiple batches of feed.
Page last modified on 20 nov 08 17:05
