Why attending the Masterclass: CMC on Cell Therapy Products
By attending this masterclass, you will gain the knowledge and skills necessary to develop and manufacture cell therapy products with confidence, while also staying up-to-date with the latest CMC trends and regulatory requirements.
in addition yo will:
- Gain a comprehensive understanding of CMC considerations for cell therapy products: The course covers a range of topics, from development to manufacturing, quality control, and regulatory compliance, providing you with a thorough understanding of CMC considerations for cell therapy products.
- Learn from experienced industry professionals: The masterclass is led by a team of experienced industry professionals with a proven track record of success in the biopharmaceutical industry. They will provide you with valuable insights and practical advice based on their experience in the field.
- Engage in interactive exercises and case studies: The masterclass includes interactive exercises and case studies, giving you the opportunity to apply your knowledge to real-world scenarios and gain practical experience in CMC for cell therapy products.
- Network with peers: The masterclass provides an excellent opportunity to network with peers in the field of cell therapy product development, manufacturing, and regulatory affairs. You can exchange ideas and insights, learn from each other’s experiences, and build valuable professional connections.
- Receive a certificate of attendance: Upon completion of the masterclass, you will receive a certificate of attendance, which you can add to your professional credentials, demonstrating your commitment to continuing education and professional development.
Session 1: Introduction to Cell Therapy Products and CMC Considerations
- Overview of cell therapy products and their development process
- Regulatory requirements for CMC of cell therapy products
- Key CMC considerations for cell therapy product development
Session 2: Characterization and Control Strategies
- Cell characterization and identity testing
- Control strategies for raw materials and critical quality attributes
- Process development and optimization for cell therapy products
Session 3: Manufacturing and Scale-Up
- Manufacturing strategies for cell therapy products
- Scale-up considerations and challenges
- Validation and quality control of manufacturing processes
Session 4: Formulation and Delivery
- Formulation considerations for cell therapy products
- Delivery methods and their impact on CMC
- Stability testing and storage of cell therapy products
Session 5: Analytical Testing and Quality Control
- Analytical testing strategies for cell therapy products
- Quality control considerations and methods
- Product release testing and batch record review
Session 6: Regulatory Compliance and Emerging Trends
- Regulatory compliance strategies and considerations for cell therapy products
- Emerging trends in CMC for cell therapy products
- Case studies and interactive exercises
The masterclass will be led by a team of experienced industry professionals with expertise in cell therapy product development and CMC. Our trainers have a proven track record of success in the biopharmaceutical industry and are dedicated to sharing their knowledge and experience with the course attendees.
This masterclass is designed for professionals involved in the development, manufacturing, and regulatory affairs of cell therapy products. This includes scientists, engineers, regulatory affairs specialists, quality control personnel, and other professionals working in the field of cell therapy product development.
The fee for attending this two-day masterclass is 1,199 € per person. However, if six or more attendees register from the same company, a 30% discount will be applied to the total registration cost. This includes all course materials during both days. Attendees will also receive a certificate of attendance upon completion of the masterclass.
Note: the 30% discount will be applied to the total registration cost of all attendees from the same company. For example, if six attendees register from the same company, the total cost for the group will be discounted by 30% of the original price, bringing the total registration cost down to 839.3 € per person. This discount applies to all attendees from the same company who register for the course.