Abstract
This article reviews the development strategy for cGMP manufacturing scale-up, and details the developmental results from process optimization experiments from several unit operations. Operational parameters studied include: agitation speeds, processing times, gas stripping rates, diafiltration variables, etc. Parameters were evaluated against defined product specifications.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 8-18 |
| Number of pages | 11 |
| Journal | Pharmaceutical Engineering |
| Volume | 19 |
| Issue number | 2 |
| State | Published - Mar 1999 |
| Externally published | Yes |
All Science Journal Classification (ASJC) codes
- Pharmaceutical Science