Time and place
- When
-
- 20. Feb 2024, 2:30 PM - 3:30 PM
- Event type
- Fagseminar
- Organizer
- Mohn Research Centre for Regenerative Medicine (MRCRM)
- Where
-
Auditorium 4, BB-Bygget
Jonas Lies vei 91
5009 Bergen
- Bygg for Biologiske Basalfag
Title
How to obtain a manufacturing license according to current good manufacturing practice (GMP) regulations.
Abstract
Key personnel at Section for cell-based medicinal products (CMP) will present the Ex-vivo clean room facility at Helse Bergen HF. The talk will include the process so far and the remaining work to be done before being able to obtain a manufacturing license for advanced therapy medicinal products (ATMPs). A brief overview of the facility and how it is qualified, tested and maintained will be followed by main points regarding establishment and validation of both the production processes and quality controls crucial for releasing the products for patient treatment in clinical trials.
About the speakers
Photo Credit: Øystein Fykse, Helse Bergen HF
Elin Strand, PhD, is the Head of Quality Control (QC).
Kimberley Joanne Hatfield, PhD, is head of Section for CMP, head of Quality assurance (QA) and Qualified Person (QP).
Petra Vogelsang, PhD, is the Head of Production.