Cellular Therapy Core Lab

What is the mission of the Cellular Therapy Core Lab?

The mission of the Cellular Therapy Core Lab is to develop, perform, and facilitate cell-based technologies for clinical application.

  1. Provide UF Health investigators with a centralized resource for product collection, processing, cryopreservation, storage, preparation, and administration of clinical product applications.
  2. Provide UF Health investigators with opportunities to translate investigator initiated cell-based technologies from the research laboratory to clinical venues.
  3. Provide and assist UF IRB-approved investigators with biorepository of hematopoietic stem cell research products and samples for translational research applications.

What services does the Cellular Therapy Core Lab provide?

Clinical Cell Therapy Lab for the following services:

  • Collection
    • Bone Marrow
      • Requires General/Epidural/Spinal Anesthesia
        • Posterior Iliac Crests – Multiple 5-7 mL/aspirations
        • Multiple puncture sites
        • Marrow is filtered, diluted, and anticoagulated
          • Will contain spicules, RBCS, and Plasma
        • Apheresis
          • Close system, Continuous flow
          • Anticoagulant (ACDA) is used
            • Quickly metabolized by liver
          • Requires use of mobilization agents to allow for efficient collection of nucleated cells (containing CD34+ Cells)
          • Requires venous access (peripheral or central venous line placement
        • Cord Blood
          • Available through Public Cord Blood Banks
            • LifeCord (Gainesville) Medical Director – Dr. John Wingard, M.D.
          • Access through Registry
        • Adipose Tissue
          • Fat tissue collected by liposuction
  • Processing
    • Environmental Monitoring (EM) Program performed for viable and nonviable particulates within laboratory, BSCs
    • Cellular Enumeration
    • Flow Cytometry Testing
    • Cell Viability Assays (Trypan Blue, 7AAd, PI, Other)
    • Colony Forming Unit (CFU) Assays
    • Microbial Testing:
      • Bacterial, Fungal Culture Testing
      • Gram Stain Testing for Gross Cont.
    • Endotoxin Testing
    • Validated Processing Protocols, SOPs
      • Volume Reduction (plasma and/or pRBCs).
      • Processing for major, minor ABO incompatibilities in cellular products.
        • pRBC (major) or plasma (minor) reduction.
      • Processing to obtain a mononuclear fraction (MNC) of the cellular product (Cobe Sectra™ or BioSafe Sepax™).
      • Processing to obtain a selected marker/sub-population in clinical product (i.e. CD34+, Miltenyi CliniMacs™).
      • Cryopreservation, thaw, wash, and infusion.
    • Receive Clinical Cellular Therapy Products
      • Both internal and external UF Health sites.
    • Perform “Minimally Manipulated” Processing Operations
      • Minimally Manipulated – The degree and complexity of any ex-vivo manipulation govern processing facility requirements.
      • More than Minimally Manipulated – May require a cGMP specification processing, w8ith either the use of a clean-room or closed-system processing.
    • Policies and procedures, using aseptic technique, are designed to prevent product mix-up, contamination or cross-contamination.
    • Regulatory Compliance
      • Experienced in performing investigative practices in accordance with applicable federal, state, and regional regulations.
      • Adhere to Code of Federal Regulations (CFR) system of guidance, outlining aspects of production and testing which may impact the quality of a product.
      • Abide by applicable current (c) practice classifications based on the project and level of risk.
        • GLP, GTP, GCP, GMP
  • cGMP Regulations – Described in 21CFR Parts 210, 211 and 600 to 680 (refer to fda.gov)
    • Assures that the requirements for safety, identity, potency, quality and purity are met.
    • Applies to IND pathway to BLA or 510(k) pathway IDE to pre-market approval.
    • Depends upon process discussed with FDA during IND (Investigative New Drug Application) approval or manufacturing facility inspection at licensure.
    • Common for phase II/III clinical trials and licensed products. May not be necessary for phase I trials.

Does the Cellular Therapy Core Lab have any new services it anticipates adding soon?

No plan to add any additional services at this time.

How should you contact the Cellular Therapy Core Lab to engage its services in a project or ask advice?

Investigators interested in utilizing the Cellular Therapy Core Lab should contact one of the following individuals to request services:

The UF Health Cancer Center (UFHCC) does not provide financial assistance for services of the Cellular Therapy Core Lab.  However, if you are interested in becoming a Cancer Center member, please visit the Membership Policy and Application site.  For further questions about membership with the UFHCC, please contact Wendy Malorzo or call (352) 273-8154.

How can you provide feedback on the Cellular Therapy Core Lab?

Clients are welcome to provide feedback on the Cellular Therapy Core Lab.  To provide feedback about the core services, please send all comments to Emma Rosenau at roseeg@shands.ufl.edu.