Ensuring Process Robustness and Product Quality in Late-Stage API Crystallization by a Standardized Project Flow
***Live: Wednesday, November 4, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET ***Looking for best approach to control the critical quality attributes of your API? Hear experts from Janssen and WuXi STA describe current technologies in API crystallization and their experience in building robust processes.***On demand available after airing until Nov. 4, 2021
Register free: https://www.pharmtech.com/pt_w/project_flow
Event Overview: API quality must be sufficiently controlled for drug efficacy and patient safety; however, this quality control cannot be achieved without a reliable control strategy and robust API crystallization process.
Advanced technologies including in-line and offline process analytical technologies, process simulation software, and in silico software are tools to aid understanding of the crystallization process. However, it is the systematic investigation that ensures a robust process control.
Following a standardized project flow will make sure that thorough understanding is built throughout the late-stage development.
Key Learning Objectives:
- How crystallization can control critical quality attributes of the drug substance
- The benefits of a structured workflow to develop a robust API crystallization process
- Typical challenging case studies in crystallization development and possible solutions
Speakers: Bjorn Gielen, PhD, Senior scientist, Crystallization Technology Unit (CTU), Janssen Pharmaceutica
Haojuan Wei, PhD, Director, Process Engineering Enabling Technology (PEET), STA Pharmaceutical, a WuXi AppTec Company (WuXi STA)
Time and date: Wednesday, November 4, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET
On demand available after airing until Nov. 4, 2021
Sponsor: Wuxi AppTec
Register free: https://www.pharmtech.com/pt_w/project_flow
