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) |
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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