Lonza's expert team can help you navigate through the complexities of tissue sourcing and applicable regulatory guidelines. We have extensive experience acquiring tissues for our client’s clinical trials, positioning them for a successful transition to commercialization. We offer client specified donor, tissue, and cell programs to build unique programs for each client. To assist clients with current donor eligibility requirements, the tissue acquisition team develops 21 CFR Part 1271 compliant donor selection, screening, testing, and qualification programs to ensure the safe and ethical sourcing of human tissue. Lonza’s team has both the experience and credentials to manage your tissue acquisition.

Why Lonza?

We are accredited with the following:

  • FDA registered facility for human cells, tissues, and cellular and tissue based products
  • Licensed by the states of Maryland, New York and California
  • AATB accredited

Our staff has with extensive experience:

  • Experience in designing donor programs to meet global regulatory requirements
  • Our staff ranges from the lead scientist who serves on the Standards Committee of the American Association of Tissue Banks (AATB), to physicians with in-depth expertise in donor testing and eligibility criteria and specialists who handle logistics, control, and documentation.
  • Staff CITI-certified in Protection of Human Research Subjects

Below is our step-by-step Program Development Process:

Step 1: Customize Program Set-Up

  • Builds unique plan to meet clients’ specifications for tissue acquisition
      • Establishes donor selection, screening, testing plan to fit inclusion/exclusion criteria for suitable donor
      • Secures tissue sourcing partnerships
      • Ensures that the program meets the regulatory and ethical criteria

Step 2: Donation Program Implementation

  • Obtains donor permission for use of to-be-acquired tissue
  • Protects client by maintaining donor anonymity and traceability
  • Uses custom transport media, containers, qualified shipping methods and documentation for incoming tissue
  • Follows regulatory requirements for determining donor eligibility that includes:
      • health evaluation through medical records
      • physical examination or assessment
      • medical and risk behavioral questionnaire
      • infectious disease testing
      • Medical Director review
    • Finishes with Quality Assurance approval and release

    Step 3: Follow-up Phase

    • Cross reference to Lonza’s Human Tissue and Cells Donor Programs Master File
    • Continues to support clients’ regulatory filings