Table 3.
Summary of strategies used for a standard and accelerated mAbs
| Category | Standard strategy | Accelerated strategy |
|---|---|---|
| Late-stage process development (PD): | ||
| Cell bank used | MCB or WCB | RCB |
| Medium and process conditions | Optimization for 3-6 months | Platform fit within 1-2 months |
| Scale-up runs | MCB or WCB | RCB |
| Late-stage, pivotal, and PPQ GMP campaigns: | ||
| PD, tech transfer, and MBR preparation | Staged one by one | Simultaneously |
| Cell bank | WCB | MCB |
| Process characterization (PC): | ||
| FMEA | After completion of PD and pivotal campaign with all data generated | In parallel with PD and pivotal campaign, when partial PD and pivotal campaign data generated, while leveraging platform knowledge and other project experiences |
| Media and seed culture used in PC | Generated in lab only | Generated in either lab or GMP facility |
| SDM development | Multiple screening runs for all parameters | One run for scale-dependent parameters only |
| SDM qualification before PC studies | With sufficient SDM lab and large-scale data | Preliminary qualification with limited PD and large-scale data |
| SDM qualification before PPQ campaign | NA | Retrospectively qualify SDM using sufficient PC lab and pivotal campaign data |
| PC studies before PPQ | Raw materials and medium preparation, inoculum expansion, seed and production bioreactors, LIVCA, and worst-case linkage studies | Focus on the most important PC studies: production bioreactor DOE and LIVCA |
| PC studies after PPQ | NA | Worst-case linkage PC study |
| PC report writing and approval | To support IPC reports Before PPQ initiation | After PPQ initiation |
| PC memo writing and approval | NA | To support IPC reports |
| In-process control (IPC): | ||
| PC data format to support IPC | Final PC reports | PC memos as appendices |
| Raw Materials, Inoculum, and Seed Bioreactors IPC reports | Written before PPQ using PC data | Written before PPQ using PD and pivotal campaign data as memos, platform knowledge, and other project experiences |
| Production Bioreactor IPC report | Written before PPQ using PC data | Written after PPQ vial thaw, but before first production bioreactor run using PC data |