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How to Prevent Damage to Biomaterials During Shipment

We’re often asked by our clients what packaging and containment materials should be used to help prevent damage to their shipment contents.

In reviewing shipper “packouts” with clients for upcoming studies or when planning for commercialization, their questions are often centered around physical and regulatory considerations, or challenges they have experienced first-hand such as:

  • Contents not arriving securely due to transport handling
  • Content leakage at refrigerated or ambient temps
  • Breakage of blood bag contents in corners or other areas of the bag
  • Breakage when removing the bag upon arrival

The underlying concern is how can their valuable temperature-controlled biomaterials be protected, remain intact, and maintain integrity during transport and upon receipt?

FDA’s Recent Outlook and New Policies for Cell and Gene Therapies

On January 15th FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D, Director of the Center for Biologics Evaluation and Research released a public statement which outlined new policies and the FDA’s outlook for cell and gene therapies.

The FDA is anticipating that they will receive more than 200 new investigational drug applications (IND) per year by the year 2020.  For some perspective, today there are a total of approximately 800 active IND’s on file with the FDA.  Additionally, the statement predicts that the FDA will be approving 10 to 20 new cell and gene therapy products per year by 2025.