Sourcing human tissue for commercial manufacture of cell-based therapies and devices

The key to success

Among the many challenges that face manufacturers of human cell-based therapies and medical devices, a few key issues stand out—the ability to scale and the need to reduce risk.

The National Disease Research Interchange (NDRI) has worked for over 35 years to build the infrastructure needed to provide scalable solutions for the acquisition of high quality human tissue that meet the regulatory demands of cell-based therapies. We partner with clients from early phase development through commercial scale production.

How we can help you

Leverage NDRI’s experience in human tissue acquisition services for assistance with:

  • Tissue procurement for complex projects and commercial usage
  • Risk Mitigation and Risk Management
  • Project Scale-Up
  • Determination of Donor Eligibility
  • Regulatory Compliance
  • Procurement and Logistic Optimization

 

Scalable and consistent

Our experienced teams ethically source human tissue and organs from FDA 21-CFR compliant Organ Procurement Organizations (OPOs) and Tissue Banks located across the US. NDRI will ensure access to high quality tissue:

  • Through our nationwide sourcing network, we will work with you to supply a steady volume of human tissue needed to match your manufacturing stage of production
  •   Access to highly trained staff of technical professionals with experience building donor eligibility programs in accordance with 21 CFR Part 1271 (HCT/P)

 

We provide the highest level of service to support your commercial manufacturing needs via 24/7 availability of our scientific staff to consult with you from start to finish.

Risk reduction

Exposure to risk is of the utmost concern for many organizations we work with. NDRI has implemented standardized procedures and works only with qualified partnerships to diminish your exposure. 

  • NDRI maintains a nationwide network of Tissue Source Site (TSS) partnerships, comprised of OPOs, Tissue Banks, and Eye Banks that are accredited by The Association of Organ Procurement Organizations (AOPO) and The American Association of Tissue Banks (AATB), respectively
  • Our TSS partners are audited biennially to ensure compliance with Uniform Anatomical Gift Act (UAGA), the Food and Drug Administration (FDA), AOPO, AATB, Eye Bank Association of America (EBAA), and where applicable the College of American Pathologists (CAP)
  • Our Logistics Management and Biorepository are accredited by The College of American Pathologists (CAP)
  • NDRI maintains compliance with applicable federal and state requirements for the recovery and transport of human organs and tissue for research
  • Non-profit mission-driven organization dedicated to the success of research and life-saving therapies

 

Experience you can count on

Our team includes highly skilled scientists, compliance specialists, project managers, and experts in procurement and logistics management. They are:

  • Experienced in building donor programs to meet FDA regulatory requirements
  • Experienced in developing FDA-compliant cell therapy platforms
  • Technical expertise in tissue acquisition, packaging and logistics
  • CITI-certified (Collaborative Institutional Training Initiative, University of Miami) in regulatory and compliance matters
  • Trained in Project Management Institute (PMI) best practices
  • Experienced in FDA GxP regulatory compliance

 

About NDRI:  A 501c3 non-profit founded in 1980, NDRI is the nation’s leading source of human tissues, cells and organs for scientific research, and a trusted resource of the National Institutes of Health for over thirty years.

For more information and questions on how NDRI can be your partner of choice, contact Gene Kopen, PhD at gkopen@ndriresource.org, 800-222-NDRI (6374), ext. 289

Cell Therapy - Cells

Cell Therapy - Cells

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NDRI is a Not-For-Profit (501c3) Corporation.