| 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 | |||||||||||||
