Environmental Monitoring In The Manufacturing Of Cell And Gene Therapies

Environmental monitoring (EM) is an important laboratory control that provides information on the cleanliness of the area where aseptic processing is executed. A stringent EM program is critical to the success of biological products such as cell and gene therapies (CGTs). This blog post will provide an overview of EM and some key considerations.

EM is performed routinely and during active manufacturing runs. The main goal of an EM program is to ensure that the facility meets the regulatory requirements for manufacturing of safe and effective products. EM will not provide a direct readout of batch sterility, but instead generates important information about the cleanliness of equipment and clean rooms, performance of air handling systems, effectiveness of cleaning operations, and whether proper aseptic technique is being used by personnel.