SCN and CATTI Workshop – Industry Skills for the Cell and Gene Therapy Sector

Stem Cell Network is excited to partner with the Canadian Advanced Therapies Training Institute (CATTI) to host the “Cell and Gene Therapy Industry Skills: Product Development and Lifecycle” learning series which will introduce attendees to good practice standards (GxPs) in cell and gene therapy manufacturing and how they apply throughout the product lifecycle. The three 1.5-hour interactive, live online workshops will provide a foundation in topics related to biomanufacturing and product development workflows, with the intention of enabling trainees to understand and plan for future careers in industry within the cell and gene therapy sector.

Learn more

Application Deadline: January 10, 2024
Course Dates: February 14, 21, and 28, 2024
Location: Virtual (Zoom)

Topics covered will include:

• Cell and gene therapies: Process development and preclinical phases
  • Quality by Design
  • Selecting critical raw materials
  • Good Laboratory Practice (GLP): Pre-clinical proof of concept/safety/toxicology studies
• Transition to production under Good Manufacturing Practice (GMP)
  • Tech transfer and engineering runs
  • Working with a Contract Development and Manufacturing Organization (CDMO)/Contract Manufacturing Organization (CMO)
  • Quality Management Systems (QMS)
• Case Studies in Cell and Gene Therapy Product Lifecycle
  • Implementation of qualification and validation procedures
  • Performing Failure Modes and Effects Analysis (FMEA) and Corrective and Preventive Action (CAPA)
  • Supply chain and logistics

Speakers

• Craig Hasilo (Chief Scientific Officer, CATTI)
• Domhnall McGowan (Regional Manager, GMP Training Sites and Training, CATTI)

Who should attend?

This opportunity is open to trainees/highly qualified personnel (HQP) (i.e., graduate students, post-doctoral fellows, research associates and research or clinical support staff) currently working in the field of stem cells and regenerative medicine in a Canadian lab seeking to expand their understanding of the processes underpinning the translation of cell and gene therapies.

Learning objectives

After this workshop, the trainee will be able to:

• Recognize terminology and explain core concepts related to Good Practices (GxPs), including Good Laboratory Practices, Good Manufacturing Practices, Good Documentation Practices) in biomanufacturing.
• Explain the differences between a controlled production environment and a research/academic non-controlled laboratory environment from a GxP perspective.
• Explain the basics of Quality by Design and Risk Management.
• Summarize a typical workflow of biomanufacturing of cell and gene therapies, highlighting career opportunities at each stage, including: R&D, process development, quality control, upstream processing, downstream processing, fill and finish.

Trainees will receive an invitation with a Zoom link for each workshop. Slides will be made available to trainees prior to each workshop. A final assessment will be created to evaluate that the training objectives have been met. A certification of completion will be given after the final assessment (pass mark: 80%).

Apply here

Questions

For further information on this seminar series or for registration related enquiries, please contact trainingSCN@stemcellnetwork.ca.