Why ATMP cleanrooms require a fundamentally different contamination control strategy, since no post-process sterilization option exists for cell and gene therapy products.
This course covers why contamination control is uniquely critical for ATMP manufacturing, and why no post-process sterilization option exists for cell and gene therapy products. It works through the regulatory framework governing ATMP cleanroom contamination control, EU GMP Annex 1 2022, EudraLex Part IV, ISO 14644-1 and the anticipated EMA Part IV revision, the Contamination Control Strategy requirement under Annex 1 Section 4, and the unique contamination risks in ATMP manufacturing that don't exist in conventional sterile manufacturing, including cross-contamination between patient batches and the conflict between GMP outward airflow cascade and biosafety inward containment requirements.
A conventional sterile product with a contamination event can often be rejected and remanufactured. An autologous ATMP batch, made from a single patient's own cells, cannot. That single fact is why ATMP contamination control cannot simply borrow the conventional sterile playbook.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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