MFDS Adjusts Number and Volume of Aseptic Test Samples for Small-Scale Production of Autologous Cell Therapy Products

by Byun Seonjin

Published 23 Jun.2023 09:17(KST)

The Ministry of Food and Drug Safety announced on the 23rd that pharmaceutical companies will adjust the number and volume of samples required for sterility testing when producing small-scale autologous cell therapy products.

Until now, in the case of autologous cell therapy products or allogeneic cell therapy products produced in small quantities, performing sterility tests according to the methods specified in the process documents consumed a large amount of samples, leading to a shortage of drugs available for patient administration. The Ministry explained that to address this issue, it has specifically presented the number and volume of samples for sterility testing of small-scale or low-volume products based on scientific evidence such as detection limits of test methods and international standards.

Since the amount of cell therapy products manufactured on a small scale may decrease due to samples consumed in testing, the Ministry added that if the filling volume is consistently confirmed during the manufacturing process, the practical dose test on the final product may be exempted.

Furthermore, the Ministry stated that for cell therapy products that are administered immediately without freezing after manufacturing, the faster the sterility test results are confirmed, the quicker they can be administered to patients. Therefore, in addition to the 14-day sterility test, a 7-day culture-based rapid detection method has been introduced.

Also, the Ministry noted that while exogenous virus contamination tests must be conducted for each lot, in the case of allogeneic cell therapy products, safety can be demonstrated by utilizing accumulated existing test results, allowing tests to be performed at regular intervals.