No. | Process Description | Time schedule | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CY2021 | CY2022 | CY2023 | ||||||||||||||
NOV | DEC | JAN | FEB | MAR | APR | MAY | JUN | JUL | AUG | SEP | OCT | NOV | DEC | JAN | ||
01 | Gene optimization | |||||||||||||||
02 | Cell Bank Optimization | |||||||||||||||
03 | Upstream process development | |||||||||||||||
04 | Downstream process development | |||||||||||||||
05 | In-Process control development | |||||||||||||||
06 | Quality control development | |||||||||||||||
07 | MCB & WCB generation | |||||||||||||||
08 | Production implementation (cGMP & Eu-GMP) | Sample production for testing(non-GMP) | GMP |