A Cell Therapy Industry Turning Point

How quality system audit standardization can increase collection capacity and reduce risk

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Starting material collection can set the fate of your final cell therapy product. Quality matters.

That’s why your site qualification process—including your quality system audit—for each site is so important. But with the rapid proliferation of cell and gene therapies, current processes are unsustainable and could cripple cell collection site capacity.

That could mean delays in your therapy development. There are solutions.

In our Case In Point, the authors illustrate how standardization through a quality system audit program can create immediate efficiencies and reduce the risk of delays.

Authors include:

  • Heather Steinmetz, MPH, Quality Assistance Manager, UCLA Health Hematologic Malignancy/Stem Cell Program
  • Amy Hines, RN, BSN, Director, Collection Experience, National Marrow Donor Program®/Be The Match®
  • Richard Smith, Independent Consultant, Be The Match BioTherapies®

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