Overview: Highly Potent API (HPAPI) manufacturing poses various challenges to different organizations. Whether you are part of a pharmaceutical company or a supply organization, special consideration must be paid to the design of the working areas and process development before a process can be transferred into HPAPI manufacturing. In this webinar, Conrad Roten will provide an overview of the key factors to run a successful HPAPI process in the plant. Included in the presentation are several short case studies highlighting the application of some of these key factors in the preparation phase, including the application of process analytical technology (PAT) to develop safe processes, as well as information on the preparation of a successful HPAPI manufacturing process.
Areas covered in the webinar:
- Key factors for successful HPAPI manufacturing
- PAT application in the development of HPAPI processes
- Verification programs in HPAPI manufacturing
- Case Studies in PAT application for HPAPI projects as well as verification studies and the necessary preparation for HPAPI manufacturing
Who should attend?
- Chemists from R&D and Production
- Procurement and outsourcing professionals
- Chemical engineers involved in developing safe and efficient production facilities
- Regulators interested in gaining a better understanding of the procedures required for robust HPAPI development and manufacture
Main Speaker:
Dr. Conrad Roten
Group Leader, Early Phase & HPAPI R&D
Lonza Custom Manufacturing
Lonza AG, Switzerland
Accompanied by:
Dr. Tobias Merz
Lead, PAT Team
Lonza Custom Manufacturing
Lonza AG, Switzerland
Dr. Rainer Jossen
Head, Launch Plant Operations
HPAPI
Lonza Custom Manufacturing
Lonza AG, Switzerland
Moderator:
Ann M. Thayer, Ph.D.
Senior Correspondent
C&EN
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