CMC and GMP for Biomanufacturing; Biologics and ATMPs Training

This 2-day (19-20 June 2024) training course will explore two essential aspects of biomanufacturing: CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practice). These concepts are crucial for the development and production of biologics and ATMPs (Advanced Therapy Medicinal Products).

Compliance with GMP regulations is essential to guarantee the safety, efficacy, and quality of biologics and ATMPs. It helps minimize risks, prevent contamination, and ensure batch-to-batch consistency. GMP guidelines are enforced by regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and other relevant agencies worldwide. Throughout this workshop, we will delve deeper into CMC and GMP principles, discuss case studies, and explore the latest advancements in biomanufacturing for biologics and ATMPs. We hope this knowledge will empower you to contribute effectively to the field and advance the development of innovative therapies.

1. AN INTRODUCTION TO CMC
2. (BIO)CHEMISTRY
3. MANUFACTURING
4. CONTROL
5. INTRODUCTION TO THE PARADIGM SHIFT IN GMP CONSIDERING
6. CONTROL STRATEGIES
7. PROCESS RISK MANAGEMENT
8. PRINCIPLE GMP CONTAMINATION OF CONTROL MEASURES AND MONITORING
9. FILL AND FINISH OF BIOLOGICAL PRODUCTS AND ATMPS