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)|
|Number of pages||11|
|State||Published - Mar 1 1999|
All Science Journal Classification (ASJC) codes
- Pharmaceutical Science