PT - JOURNAL ARTICLE AU - Rhona M. O'Leary AU - Tina Etcheverry AU - Paul Bezy AU - Vincent Anicetti AU - Louis E. Burton TI - Use of Pilot Plant Facilities to Aid Validation Programs DP - 2001 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 230--234 VI - 55 IP - 4 4099 - http://journal.pda.org/content/55/4/230.short 4100 - http://journal.pda.org/content/55/4/230.full SO - PDA J Pharm Sci Technol2001 Jul 01; 55 AB - According to the FDA guidelines (1), pilot plant facilities may be used to generate material to support process validation studies. The guidelines also state that process modifications are an inevitable part of process development and scale-up. However, if such modifications are made, there is a need to demonstrate that the products from both the old and new processes are comparable (2). Both of these guidelines were combined and applied during a recent development of a product at Genentech. In order to implement the process modifications and demonstrate product comparability, the pilot plant facilities were used for these production runs. As the process had changed, and the product was being prepared for BLA submission, inprocess samples from the new manufacturing process were also required to support the process validation studies. By using pilot plant facilities to implement the process modifications, test product comparability, and produce material for process validation, we were able to minimize the impact of such work on the large-scale manufacturing facility.