Hematopoietic Biorepository and Cellular Therapy

Services

The Hematopoietic Biorepository and Cellular Therapy Shared Resource (SR) serves as a resource for procurement, processing, storage, banking, analysis, and distribution of cells derived from clinical-grade production, human blood, bone marrow, and umbilical cords.

The SR is comprised of two components:

1. A human hematopoietic biorepository and support services to facilitate basic hematopoietic research

2. A clinical Cellular Therapy Lab that manufactures clinical-grade cell products for investigational and standard of care therapies

Facility Objectives

• To procure, de-identify, process and distribute human blood, umbilical cord blood, and bone marrow cells from healthy volunteers and patients to investigators
• To maintain a biorepository of collected samples
• To perform and assist investigators with standard assays to evaluate hematopoiesis and hematopoietic and mesenchymal stem cells
• To support cell therapy-based clinical trials from the proof of concept stage throughout the clinical trial

List of Services

1. Procurement and distribution of human hematopoietic cells:
   • The SR maintains an active IRB protocol to enable the recruitment of donors and procurement and distribution of de-identified blood and bone marrow samples to research investigators. We also maintain a Biorepository to supply investigators with cryopreserved samples. Sample types obtained include:
     • Normal donor blood
     • Normal donor bone marrow aspirate and/or biopsy samples
     • Umbilical cord blood
     • Peripheral blood mononuclear cells and mobilized hematopoietic progenitor cells (leukopaks)
     • Bone marrow mesenchymal stromal cells
     • Blood and/or bone marrow from patients with a wide variety of hematologic diseases including AML, ALL, CML, CLL, multiple myeloma, and anemia
2. Processing and analysis of hematopoietic cells:
   • The SR assists investigators with the processing and analysis of hematopoietic cells using a variety of methodologies. Examples of some of these procedures include:
     • Separation of mononuclear cells by density gradient (Ficoll-Hypaque or Percoll)
     • Cell enrichment using MACS magnetic bead separation (ex. CD8 cell isolation)
     • Isolation and expansion of mesenchymal stromal cells
     • Maintenance of specialized equipment available for research use including a hematology analyzer to perform CBCs
     • Performance of colony forming unit assays (CFU) on blood and bone marrow products
     • Separation of plasma/serum
3. Production of clinical grade cellular therapy products
   • Technology transfer of cellular therapy research products to clinical scale
   • Custom cell manufacturing to support IND applications
   • Manufacturing competencies include generation of GMP-compliant CAR-T, gene edited T cells, NK cells, MSCs, hematopoietic stem cells, viral specific T cells, lentiviral and adenoviral gene transfer, dendritic cell vaccines
4. Support capabilities to transition preclinical studies into clinical trials
   • Assistance in the design and preparation of cells for Good Laboratory Practices (GLP) safety studies
   • Investigational New Drug Application (IND) support
   • Sourcing of clinical grade supplies and reagents
   • Scale up from research to clinical operations

Resources

Hemavet Hematology Analyzer
MACS Quant cytometer
CliniMACS Prodigy
Terumo Quantum bioreactor
Cytiva Xuri bioreactor
Countess III FL
Nanodrop One
Nexgen PTS rapid endotoxin
Biorad QPCR machines
ISO 7 cleanroom suites (6) each with incubators, centrifuge, biosafety cabinet, microscope, refrigerator
GMP-trained lab personnel
Rate controlled freezing chamber
Research grade MACS magnet for cell enrichments or depletions
Shandon Cytospin

Acknowledgment

Remember to acknowledge the valuable services provided by Cancer Center Shared Resources in your research papers and publications: 
"This research was supported by the Hematopoietic Biorepository and Cellular Therapy Shared Resource of the Case Comprehensive Cancer Center (P30CA043703)."

Contact for Information