Speaker: Ion Tcacencu – is an ATMP expert with over 17 years of experience as scientist within regenerative medicine and immunology, being responsible for projects developing new ATMPs.
Ready to explore the cutting-edge world of Advanced Therapy Medicinal Products (ATMPs)?
Don't miss our exclusive webinar where we delve into the intricacies of ATMPs development and manufacturing! Sign up now for an insightful agenda featuring key topics:
- General aspects of the ATMPs development.
- Overview of the Quality Target Product Profile (QTPP) and critical quality attributes (CQAs).
- ATMPs manufacturing lifecycle and workflow (research-grade vs GMP).
- Revealing the importance of the Drug Development Plan (DDP).
- Case studies of scaling up somatic cell based medicinal products (SCBMPs).
Key Learning outcomes/objectives:
- Comprehend the complexity of ATMPs development and manufacturing, gaining a deep understanding of the field's intricacies.
- Address the unique challenges involved in transitioning ATMPs towards clinical manufacturing, considering regulatory requirements and quality control.
- Mitigate the risks associated with scaling up ATMPs, by exploring successful strategies and lessons learned from case studies