Figure 2.

Standard mAb PC timeline versus the accelerated PC timeline of mAb1 and mAb2 togetherTiming of FMEA, SDM qualification, PC lab work, and IPC and PC report writing was shuffled for a more compacted schedule. Lab bioreactor run number for SDM development and PC studies was reduced leveraging platform knowledge. Based on different PPQ steps, IPC reports were approved in a rolling order when the data was ready. The accelerated PC timeline from upstream lock to PPQ start was shortened from a standard of 12 months to 4 months.

Alt Text: Detailed PC activities over 12-month duration for a standard PC timeline versus detailed PC activities over 4-month duration for the accelerated PC timeline of mAb1 and mAb2 together. The accelerated PC timeline from upstream lock to PPQ start was shortened from a standard of 12 months to 4 months.