New technologies generating successful cell and gene therapy approaches have contributed to a global growth of institutions that cultivate stem cells, T cells and other primary cell types under stringent conditions. These cells are exquisitely reactive to their environment and challenging to manage. For any therapeutic designed for use in a human patient, careful safeguards are inherent to the development and production. Good manufacturing practices (GMP) must be followed. As part of GMP, working in a cleanroom setting helps to produce a therapy which is safe and effective, pure, and of high quality. Culturing cells in a cleanroom under GMP comes with new challenges, and require a CO₂ incubator that can help meet these challenges by reducing risk to the therapy, including features to control particulates and contamination, compatibility with enhanced cleaning procedures, documentation to support validation processes and certification for ISO Class 5 and Grade A/B use in accordance with ISO 14644-1.

 

Learning Objectives