Services

Core services include processing of hematopoietic stem cells for autologous or allogeneic transplantation, generation of tumor vaccines using genetic or culture mediated modification of tumor cells, and preparation of immune cell populations for adoptive cellular therapy. The core also collects and stores follow-up blood and bone marrow samples from subjects treated on protocols that the core produced components for, thus providing an additional service to clinical investigators beyond what cell manufacturing laboratories provide, ensuring that all research objectives of clinical protocols are met.
Pricing varies; contact the Core for details.

Key services of the Core include:
  • Production of cellular products for patients enrolled on clinical research protocols
    • Hematopoietic stem cells
    • Tumor cell vaccines
    • Dendritic cell vaccines
    • Adoptive Cellular Therapy Components
  • Cell therapy process development, consultation, and support
    • Develop manufacturing SOPs
    • Validate processes and SOPs
    • Build and activate templates for orders to manufacture, collect, process, and release cellular products to patients (Biotherapy Order Entry, BOE)
  • Clinical trial development consultation for cellular therapeutic studies
    • Pre-clinical development and trial design
    • DF/HCC and FDA Review
    • Data management
    • Quality control
    • Internal and external audits
    • Reports and publications
  • Regulatory (internal and external) consultation and support
    • Assist with pre-IND FDA meetings
    • Assist with Chemistry, Manufacturing, and Controls (CMC) section of -IND preparation and patient consents
    • Assist PI with amendments and annual reports
    • Assist with IRB protocol submission
    • Review and sign-off on all protocols
    • Audit all IND/IDE manufacturing for compliance with IND/IDE and protocol
    • Prepare for FDA and Sponsor audits
  • Quality control (assays and testing)
  • Quality assurance
    • Regulatory (FDA) and accreditation (FACT & JC) compliance monitoring
    • Audit and review procedures, processes, and test results
    • Assist with labeling requirements
    • Monitor product non-conformances
  • Cellular product manufacturing, characterization, storage, and distribution
  • Pre- and post-treatment processing and banking of patient samples