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FDA Says Shipping Logistics Should Be Priority For Cell Therapy Products

 
• By Joanne S. Eglovitch

FDA says manufacturers need robust shipping programs to ensure the safety and quality of cell therapies, since there are no ready replacements and a patient’s life can be at risk if problems arise. Kite exec notes that “more than any other biologic, the supply chain of autologous cell therapies reaches really literally end-to-end.”

Delivery trucks are in contact with the warehouse in an illustration about shipping

FDA says that manufacturers should apply the same level of rigor to their storing and distribution programs as their development programs for cell therapy products. These are sensitive products that are highly dependent on cold temperatures for cells to survive and demand careful handling.

A series of speakers discussed some of the logistical challenges involved in distributing autologous cell therapies and the cryogenic conditions...

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More from United States

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The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

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• By Leslie Small

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• By Sue Sutter

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More from North America

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

Cassidy Confirms Agreement With Kennedy Did Not Include Maintaining CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.

ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By Cathy Kelly

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.