INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Zoom On The Importance Of Quality For Viral Vector Manufacturing Optimization

  Industry experts offer advice on the use of GMP raw materials for viral vector manufacturing along with the key points of evolution relating to regulatory guidance and requirements for viral vector production.

• Flexible Facility Design For Multi-Product Manufacturing Of Advanced Therapies

  Discover critical principles for the success of advanced therapy manufacturing facilities that benefit developers with established platform processes to sponsors and CDMOs involved in large-scale manufacturing.

• Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS)

  This fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.

• Analytical Techniques For Addressing Viral Vector Purification Challenges

  Explore challenges found in various analytical techniques during the purification process of viral vectors, particularly with regards to downstream purification of adeno-associated viruses (AAVs).

• Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical Tasks

  Determining the appropriate critical tasks to be evaluated and assessed is crucial to the Human Factors Engineering (HF/HFE) process and needs to be addressed with the appropriate risk-based approach.

• Reasons To Buy Into A Joint Auditing Program

  Learn how you can save costs and time by having access to licensable joint audit reports.

• Mitigate C&G Therapy Manufacturing Risks Amplified By COVID-19

  Understanding not only the limitations of a post-COVID manufacturing landscape, but also developing strategies to help overcome these challenges is critical to driving the future of next-generation CGTs.

• Cell & Gene Therapy Supply Chain: Early Preparation Is Key

  Supply chain management for cell and gene therapies requires precise demand planning and forecasting

• Regulatory Convergence With Aurion Biotech

  Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach that accounts for every phase of scale-up and commercialization.

• The Centre For Cell And Vector Production (CCVP)

  A world-class Good Manufacturing Practices (GMP) facility built in partnership with University Health Network (UHN), located in downtown Toronto, adjacent to some of Canada’s leading hospitals and research institutes.