Recorded Webinar with Sharon Miller: FDA Licensure of HPC, Cord Blood: How Licensure Has Improved Cord Blood Banking

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Watch the recorded webinar to hear Sharon Miller, Director of Regulatory Affairs at ClinImmune Labs, speak about the positive effects of FDA licensure on HPC, Cord Blood, and how licensure has improved cord blood banking.

 Webinar Summary

This webinar recording details the positive effects of FDA licensure on HPC, Cord Blood products.  Over a period of three years since the 2012 FDA approval, the University of Colorado Cord Blood Bank has been licensed to GMP manufacture the minimally manipulated allogeneic 351 products for distribution.  This webinar provides insight from a bank that has experienced the biologic license application (BLA) and distributed licensed products for infusion.


You will learn:

  • About the positive changes in the cord blood bank that resulted from FDA GMP licensure;
  • How cord blood products have benefited from licensed manufacturing and distribution by standardizing sterility testing and RBC content and limiting transient warming;
  • Ways to improve consistent manufacturing of HPC, Cord Blood products that are safe, pure and potent; and
  • Quality improvement details that may be implemented in the laboratory.

Sharon Miller, MT (ASCP), CHS(ABHI), helps you understand the positive effects of FDA licensure on HPC, Cord Blood, how licensure has improved cord blood banking, and also provide quality improvement details that you can implement in your laboratory.

Speaker Bio

Sharon_MillerMs. Miller is responsible for cord bank, stem cell and HLA lab regulatory compliance, quality supply and product release, accreditation, continuing education, and cord blood product evaluation for FDA Batch licensure. Ms. Miller has over 31 years of experience in Histocompatibility and Immunology, and over 12 years of experience in HPC collection, processing, banking and distribution. She is experienced with ASHI, AABB, CAP, FDA, CLIA and FACT and is an ABHI Certified Histocompatibility Specialist, and a Medical Technologist. In 2012, she successfully led the cord bank into FDA Biologic licensure as a pharmaceutical biologic drug and has been distributing and reviewing both IND and licensed products. For licensed distribution, she has been reviewing and reporting safety, distribution, annual, and CBE-30, CBE, and PAS reports to the FDA. This FDA experience has been a pivotal factor in leading to lecture presentations at the International Cord Blood Symposium, American Association of Blood Banks, Pharma, and International Society of Cellular Therapy and comparing both IND and BLA distribution of HPC, Cord blood has provided the experience to report the benefits of FDA licensure in the cord blood bank.


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