Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution

Life Sciences, Pharmaceutical Regulation, Drug Safety,
  • Thursday, October 01, 2020

The International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cell for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. This webinar will discuss the key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies. Some of the elements to be discussed are documentation, traceability, validation and qualification activities, temporary storage, as well as cleaning and disinfection.

Speaker

Robert Jones, Vice President, BioServices, Cryoport

Rob Jones is an accomplished supply chain executive with 29 years of commercial development experience and 10 years’ experience in the blood transfusion industry. Qualified in Hematology and Blood Transfusion Medicine, he originally worked at the UK National Blood Service at the Birmingham Laboratories. He then took up a technical support role at DuPont Virology Diagnostics before moving into commercial roles at Sorvall Inc and Kendro Laboratory Products. He is now responsible for the strategic expansion of Cryoport’s Bioservices initiative and will oversee the introduction of a range of new services in the field of critical supply chain support.

Message Presenter

Who Should Attend?

Industries: Pharmaceutical, Biotechnology, Life Sciences, Clinical, Health Care, CMOs, CDMOs

Job Areas: Operations, Logistics, Supply Chain, Clinical, Materials Management, Procurement and Purchasing, Management, Quality Management, Program Management, Product Management, Quality Assurance, Research, Shipping, Transportation

Job Functions: Logistics Manager, Supply Chain Manager, VP of Operations, Director of Clinical Operations, Laboratory Supervisor, Quality Assurance Manager, Lab Manager, Clinical Director, Clinical Laboratory Scientist, Laboratory Director, Quality Manager, Research and Development Manager, Research Scientist, Validation Specialist

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Cryoport

Cryoport is redefining logistics for the life sciences industry by providing a platform of temperature-controlled solutions, serving the Biopharma, Reproductive Medicine, and Animal Health markets. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences industry through our advanced technologies, Global Supply Chain Network and dedicated scientists, technicians and supporting team of professionals. Through its purpose-built, proprietary Cryoport Express® Shippers; Cryoportal® information technology; validated Global Logistics Centers; smart and sustainable temperature-controlled logistics; and biostorage/biobanking services, Cryoport serves clients in life sciences research, clinical trials, and product commercialization. We support life-saving advanced cell and gene therapies and deliver vaccines, protein producing materials, and IVF materials in over 100 countries around the world.

We have an unmatched reservoir of experience and expertise in supporting over 491 active clinical trials and we have been selected by Novartis, Kite (Gilead) and Bluebird Bio to support their commercially approved products.

Cryoport is dedicated to: simplifying global temperature logistics through innovative technology, unmatched monitoring and data capture and support, including consulting; delivering the most advanced temperature-controlled logistics solutions for the life sciences industry; and providing vital information that provides peace of mind throughout the life of each logistics process.

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