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Core Facilities

Cell Manipulation

Key Services

Key Services

  • 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)

    DFCI, in collaboration with the Partners IS Clinical Information Systems Team, created and implemented a unique suite of applications that keeps inventory and tracks orders for manufacturing, collection, and release of cellular products used in treatment plans and clinical trials. The CMCF maintains the Biotherapy Product Availability Application (BPAA) inventory system which works in tandem with a paperless order system – the Biotherapy Order Entry (BOE) application. Investigators and clinicians with plans to use cellular products are required to use BOE. Together, the applications create an electronic paper trail of a patient’s cellular therapy. Questions and contacts regarding BOE are displayed here.

    • Maintain inventory system of cellular products available for use in treatment plans and clinical trials (Biotherapy Product Availability Application, BPAA)

    DFCI, in collaboration with the Partners IS Clinical Information Systems Team, created and implemented a unique a suite of applications that keeps inventory and tracks orders for manufacturing, collection, and release of cellular products used in treatment plans and clinical trials. The CMCF maintains the Biotherapy Product Availability Application (BPAA) inventory system which works in tandem with a paperless order system – the Biotherapy Order Entry (BOE) application. Investigators and clinicians with plans to use cellular products are required to use BOE. Together, the applications create an electronic paper trail of a patient’s cellular therapy. Questions and contacts regarding BOE are displayed here.

  • 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)

    The CMCF has developed its own Quality Control Department with trained staff and qualified instruments to support the development and implementation of assays. The facility is CLIA approved. Flow cytometry-based product characterization and functional assays as well as testing for sterility, endotoxin, and environmental monitoring are carried out in the QC lab. This has markedly reduced the cost and turn around time for results reporting.

  • Quality Assurance
    • Regulatory (FDA) and Accreditation (FACT & JC) compliance monitoring
    • Audit and reviews procedures, processes, and test results
    • Assist with labeling requirements
    • Monitor product non-conformances
  • Cellular product manufacturing, characterization, storage, and distribution
  • As new clinical trials are being developed, the CMCF also works with Cancer Center members to develop and optimize manufacturing procedures for their clinical trials and to support FDA IND applications. To ensure patient safety and comply with FDA regulations, cellular products that are processed under investigational methods must meet specific safety requirements, quality control tests, and release criteria prior to human use. Assays to accurately characterize and assess the potency of specific cellular products are developed for different protocols and become important measures of manufacturing efficacy. Procedures for transporting clinical products between the CMCF and all of the affiliated clinical sites within DF/HCC have also been validated to allow the CMCF to receive, dispense, and support clinical studies at all DF/HCC clinical sites.

  • Pre and post treatment processing and banking of patient samples
  • Protocols involving the manipulation of hematopoietic progenitor cells often require assessment of engraftment and immunologic reconstitution. To support these important research objectives, CMCF also collects and stores follow-up blood and bone marrow samples collected from subjects treated on the protocols for which the facility produces components. In this way, the CMCF provides an additional service to clinical investigators and ensures that all of the research objectives of the clinical protocol are met. Although this service goes far beyond the services normally provided by cell manufacturing laboratories, the CMCF considers this an essential component of the core’s work in support of clinical research within DF/HCC.