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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.
Modern medicines call for modern technologies. Revolutionary cell and gene therapies offer significant promise to treat life-threatening diseases. Getting therapies to market quickly and efficiently requires accurate testing of critical quality attributes, including accurate viral vector analysis…
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…