Why attending the Masterclass: CMC on Gene Therapy Products
Attending the Masterclass: CMC on Gene Therapy Products offers several key benefits for professionals working in the field of gene therapy product development and manufacturing, including:
- Comprehensive Understanding of CMC Requirements: This masterclass provides a deep dive into the CMC requirements for gene therapy products, including the latest regulatory guidelines and best practices. Participants will learn how to effectively develop and manufacture safe and effective gene therapy products that meet these requirements.
- Expert-Led Training: The course is led by an experienced trainer who is a recognized expert in the field of gene therapy product development and manufacturing. The trainer will provide practical insights and real-world examples, drawing on their experience to provide attendees with a comprehensive understanding of the CMC requirements for gene therapy products.
- Networking Opportunities: Attendees will have the opportunity to network with peers in the field of gene therapy product development and manufacturing. This provides a valuable opportunity to share knowledge and best practices, as well as to make connections with others in the industry.
- Continuing Education: This masterclass provides attendees with continuing education credits that can be used to meet ongoing professional development requirements.
- 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.
Day 1:
Session 1: Introduction to gene therapy products and CMC considerations
- Overview of gene therapy products and their CMC requirements
- Regulatory requirements for gene therapy products
Session 2: Vector design and production
- Overview of viral and non-viral vectors
- Vector design and optimization
- Vector production, purification and characterization
Session 3: Analytical methods development and validation
- Development of analytical methods for gene therapy products
- Method validation and qualification
- Stability testing
Day 2:
Session 4: Process development and manufacturing
- Overview of gene therapy product manufacturing
- Upstream and downstream processing
- Scale-up and tech transfer
Session 5: Quality control testing and release
- Quality control testing for gene therapy products
- Release testing requirements
- Comparability studies
Session 6: Stability testing and characterization
- Stability testing requirements for gene therapy products
- Characterization and comparability studies
- Process and product development
Please note that the order of the sessions may be subject to change based on the latest developments in the field of gene therapy.
The trainers for the Masterclass: CMC on Gene Therapy Products have a wealth of knowledge and expertise in the field of biopharmaceuticals. They have extensive experience in gene therapy product development and CMC, having worked with some of the leading companies in the industry. Their in-depth understanding of the regulatory landscape, coupled with their hands-on experience in the design, development, and commercialization of gene therapy products, provides an ideal opportunity for attendees to learn from the experts. The trainers will be available throughout the masterclass to answer questions, provide guidance, and share their insights with attendees.
This course is aimed at professionals working in the field of gene therapy product development, manufacturing, quality control, and regulatory affairs. Specifically, this includes:
- Scientists and researchers involved in the design, development, and characterization of gene therapy products
- Engineers and process development personnel working on the manufacturing and scale-up of gene therapy products
- Quality assurance and control personnel responsible for the testing and release of gene therapy products
- Regulatory affairs professionals working on the regulatory strategy and compliance of gene therapy products.
This course is relevant for those working in academia, industry, and regulatory agencies, including biotech and pharmaceutical companies, contract manufacturing organizations, and government agencies. Attendees may include those who are new to the field and those who are looking to expand their knowledge and stay up-to-date with the latest advancements in CMC for gene therapy products.
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.