Advanced process monitoring: the ultimate alternative

Parametric release has the possibility to be the ultimate alternative for the use of animal tests. It involves the release of a product using evaluation of tightly controlled physical parameters, without the performance of a test on the final product. This practice is strengthened if there is a lack of validity for the final test to indicate quality or consistency. That suggests that in-process monitoring should replace the finished product controls when among others, batch-to-batch consistency has been formally validated. Currently, parametric release is a common practice for terminally sterilised and aseptically filled biologicals. An example is the production of inactivated cells of Bordetella pertussis which shows that new techniques are able to monitor the process in detail. Furthermore, it is shown that the production of Bordetella pertussis is well defined and highly predictable. In parallel with the tests for terminally sterilised biologicals, mouse potency tests are statistically hardly capable of indicating batch-to-batch variation. Monitoring on-line process parameters provides a better assurance of consistency and quality, thus giving the opportunity for batch release and regulatory approval without the use of animal tests.