The face of medicine is changing with the arrival of the FDA’s approved novel therapies and advanced therapy medicinal products (ATMP) on the market. The promises of curing cancer and rare genetic diseases with gene editing, cell engineering or CAR-T therapies is creating a fast-growing market where biotech companies need to adapt to the special needs of this industry. The design of regenerative medicine clean rooms can be complex as production process, size and the amount of equipment required all affect the overall cost. Whether you want to build Autologous or Allogeneic facilities, all cell and gene therapy cleanrooms needs to be cGMP compliant. As the process involves living drugs, the need for a strict and stringent cleanroom environment is critical to ensure the safety of cell-based medicinal products. CAR-T, oncology (cancer), immunotherapy, or immuno-therapy (IO) cleanroom generally include a Grade A or Grade B area (ISO 5) with Grade C (ISO 7 at rest/ISO 8 in operation) or Grade D (ISO 8) support zones.
CELL AND GENE THERAPY CLEANROOMS DESIGN CONSIDERATIONS:
Gowning rooms: Personal Airlocks (PAL) and Material Airlocks (MAL)
HVAC, air supply and airflow patterns
ISO classifications and cGMP compliance
Temperature and humidity
Environmental monitoring
Laminar Air Flow Workbenches (LAFW) / Laminar Flow Cabinet
Critical utilities (N+1 redundant utilities or backup electrical and mechanical utilities)
Sincerely Pharmaceutical Tech
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Client Success Team (CRM),
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