Biologic Therapy Core Facility                                      Click here to view PHOTOS


Mission Facility Layout Facility Resources
Equipment Raw Materials Organization Structure & Personnel
Quality Assurance Additional information  

Mission

Assist Principal Investigators in the rapid and early translation of promising novel research into clinically relevant interventions intended to treat, prevent, or improve outcomes for cancer and other diseases.

  • An FDA registered modern cleanroom facility for the manufacture of custom biologics and drugs under current Good Manufacturing Practices (cGMP) conditions for use in clinical trials.
  • Provides assistance with Investigational New Drug (IND) submissions.
  • Manufacture of Biologic and Non-Biologic therapeutics.
  • Select cell enrichments for cell therapy applications in a controlled cGMP compliant environment.

Back to Top

Facility Layout

BTC Core Facility Layout
  • Approximately 2,600 square feet
  • Six independent manufacturing suites
    •  (ISO Class 7, Class 10,000)
    •  Positive pressure to adjacent areas
    •  Equipped with BSC & Incubators
    •  Pass-through both sides
    •  Seamless cove base
  • Intermediate entry rooms (Iso Class 8)
  • Separate gowning rooms (G1, G2)
  • Flexible gowning procedure
  • Unidirectional Traffic Flow for personnel and materials
  • Validated dual-door Autoclave

Back to Top

Facility Resources

  • Full Time dedicated custodial support
  • Manufacturing Suites cleaned weekly (includes ceiling, wall, floor)
  • Change over cleaning between manufacturing campaigns
  • Environmental Monitoring Program for both viable & non-viable contaminates (established Alert & Action Levels, organism identification, trending)
  • Daily QC checks for dP, temperature, etc.
  • Automated Building Management System (Johnson Controls)

Back to Top

Equipment

  • SOP directed preventative maintenance schedule
  • 24/7 alarmed monitoring of critical constant temperature equipment (Freezers / Refrigerators)
  • Semi-annual certification of all BSCs
  • Validation Master Plan
  • Individual validation (IQ, OQ, PQ) of critical equipment
  • Individual SOPs for each piece of Equipment
  • Utilities (Electrical 110, 220, 480V, Air, Gas, Vacuum)

Back to Top

Raw Materials

  • SOP directed materials management
  • Arriving materials are received & quarantined  (defined area)
  • Materials Specifications and Release procedures
  • Separate storage area for Released and Rejected Materials
  • Material management database to track use or expiry
  • Electronic archival of material COA’s 

Back to Top

Organization Structure & Personnel

  • Facility Director
  • Operations Director: oversees daily operation of facility
  • Quality Assurance: Separate from manufacturing, oversees facilities quality systems
  • Dedicated staff and Custodial Support
  • Independent Qualified Users
  • Outside users
  • Training as per SOP, Read & Understand, Performance, cGMP, etc.

Back to Top

Quality Assurance

  • Documentation Management (SOPs, MPR, Forms, & Worksheets)
  • Document Change Control Record
  • Deviation Reporting System (root cause, corrective action)
  • Corrective and Preventative Action (CAPA)
  • Audits (Internal & External)
  • Assistance with regulatory fillings (IND, RAC, IRB, etc)
  • Regulatory Consultation
    • Evaluate and interpret regulations and standards from federal agencies and accrediting bodies to determine its applicability to a PI’s clinical trial or study
    • Act as a Liaison or go-between to the FDA on behalf of PIs and Researchers
  • Audits
    • At a PI’s request, will perform inspection of research records and documents to ensure regulatory compliance. In addition, will provide the PI and Research Staff with a summarized finding and recommendations
    • Assist PIs with external audits and inspections performed by accreditation agencies, regulatory authorities, sponsors and third party contractors

Back to Top

Additional information may be found at:

Biologic Therapeutics Center

Washington University School of Medicine
Biologic Therapeutics Center
4511 Forest Park Parkway
Suite 411
St. Louis, MO 63108