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