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LPC Snapshot: Identifying and Mitigating Common Issues When Bringing on Industry-Sponsored Technologies

  

Diane Kadidlo, BSc, MT(ASCP), SBB
Member, ISCT Lab Practices Committee
University of Minnesota
United States

J. Wade Atkins, MS, MLS, SBB(ASCP), CQA, CABP(Н)
Co-Chair, ISCT Workforce Development Committee
National Institutes of Health
United States



As cell and gene therapy pipelines expand, cell processing labs and transplant facilities face a growing burden when onboarding industry sponsored products. In this LPC Snapshot, Diane Kadidlo (University of Minnesota) and J. Wade Atkins (NIH) map common friction points and pair each with a practical mitigation strategy. Friction points such as site qualifications and audits, non-standardized sponsor requirements, ISBT 128 labeling gaps, donor eligibility, documentation, vendor qualification and out of specification products. They make a strong case for Quality Agreements to define responsibilities between centers and sponsors, pointing readers to the downloadable ISCT/AABB template. A helpful guide to reducing stress and building a more resilient program.

Click here to view the complete LPC Snapshot slide deck


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