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Top Ten CGMP Compliance Implications for Cell Therapy / ATMPs


Top Ten CGMP Compliance Implications for Cell Therapy / ATMPs

As new medicines and treatments continue to evolve, so do the challenges with their production. Cell therapy facilities present many unique challenges from the intricacies of patient-specific autologous therapies to numerous high-risk manual aseptic manipulations during the processing.

The “Top Ten List” of compliance concerns for cell therapy facilities are:

  1. Application of the FDA’s Aseptic Processing Guideline and EU Annex 1 requirements, that were primarily developed for large-scale fill/finish facilities to cell therapy facilities
  2. Facility airlock requirements and compliance driven flows: unidirectional vs. bidirectional
  3. Containment and segregation of viral vector areas and suites
  4. Transitioning and transforming from laboratory & development to commercial; Scaling-up not just scaling-out
  5. Quality Management System (QMS) development for start-ups and QMS adaptation to cell therapy operations for Big Pharma
  6. Labeling, batch records, and traceability from patient back to patient
  7. Large volumes of material transfers from unclassified → CNC → Grade D → Grade C (ISO 8) → Grade B (ISO 7) → Grade A (ISO 5) without introducing contamination
  8. Concurrent processing of multiple batches in the same room; multiple biosafety cabinets, multiple autologous batches in same incubator, etc.
  9. Equipment design (incubators, centrifuges, etc.) not conducive for Grade B and the ability to clean and sanitize
  10. Numerous open and manual aseptic manipulations

With the multitude of compliance and process challenges, cell therapy facilities of the future must resolve several underlying issues and drive progress in the following areas:

  • Separate people from product:
    • Develop processes with limited manual manipulations
    • Design for less handling of materials and product
    • Utilize isolation technology as adapted to cell therapy processes
    • Implement greater use of available automation
  • Close the process to the greatest extent possible and utilize the latest available technologies
  • Scale-up to commercial manufacturing vs. duplicating laboratory scale in greater quantities
  • Design robust facilities that can be easily cleaned, sanitized and operated in a state of control
  • Challenge vendors to develop “built-for-purpose” CGMP equipment and automation / software
  • Establish a robust Electronic Batch Record (EBR) system, bar coding, and/or labeling system to prevent possibilities of mix-up

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