Error loading player: No playable sources found

36751

Session II - Managing the Complexity of the CGTP Supply Chain

Date
June 6, 2022
This product is not available for individual purchase, but it is available as part of the following products:
Thumbnail for Cell & Gene Therapy Products 2022
The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…

Cell, gene, and other novel therapies require carefully designed and well executed logistics solutions for supplying lifesaving medicine to patients. Biological material sourced and produced for autologous and allogeneic therapies must be strictly controlled for temperature, timeline, as well as chain of identity and custody. This complexity was expanded by the COVID pandemic which has caused disruption in supply of materials, as well as manufacturing and logistics processes. On the other hand, smart technologies, digital solutions, and innovative operation models have driven the rapid evolution of global CGT clinical and commercial distribution. This session will explore the following topics:
• Planning and ensuring manufacturing capacity to serve the patient/market need.
• Solving supply chain challenges for clinical and/or commercial cell therapy products.
• Case studies of digital solution (electronic system integration), smart technologies and operation model successfully applied in supply chain management.

Related Products

Thumbnail for Session III - Current Understanding of the Product Quality Attributes that Impact Safety and Efficacy of AAV-based Gene Therapy Products
Session III - Current Understanding of the Product Quality Attributes that Impact Safety and Efficacy of AAV-based Gene Therapy Products
Adeno-associated viral (AAV) vector-based gene therapy medicinal products hold curative promise for many disease indications…
Thumbnail for Session VI - Cell Therapies
Session VI - Cell Therapies
The Cell Therapies products space is continuing to build on the potential for innovative treatments for unmet patient needs. Topics include cell products with unique manufacturing process, complex sourcing starting material, and assays with direct relevance to CQAs…
Thumbnail for Session V - Potency Assays
Session V - Potency Assays
Potency is a critical quality attribute (CQA) for cell and gene therapy (CGT) medicinal products…
Thumbnail for Identity testing by NGS as a means of risk mitigation
Identity testing by NGS as a means of risk mitigation
Imagine that you just completed a manufacturing run for a mission critical gene therapy vector. All of your release testing is underway, and you are days away from releasing your product. Per regulatory guidelines, identity testing is performed to confirm the vector sequence is as expected…