Recent progress in Advanced Cell Therapies (ACT) is raising additional questions concerning the best and proper way to manipulate cell cultures while guaranteeing solid GMP compliance and the highest efficiency from the procedures. In particular, when we extend procedures from an occasional approach to daily production, it is fundamental to maintain flexibility, maximum operative efficacy, smooth workflows and successful procedure completion.
Processing in aseptic conditions appears to be one of the biggest challenges: it is currently performed in large space classified environments known as Cleanrooms. A valid alternative to the use of cleanrooms is represented by the adoption of isolation technology. Isolators are closed, sealed glove boxes, internally decontaminated, therefore classified as Class “A” environments. Isolators allow internal manipulation without any external contact, so the surrounding environment can be a Class “D” laboratory. This brings a set of advantages (less structural construction costs, reduced HVAC needs and consumption, more flexibility in positioning the work area, no need of gowning for the operators, more productive use of their time) and some challenges (equipment investment costs which need to be carefully evaluated.
Obviously this evaluation will need to take into consideration the space needed for the manipulations to be performed and the manual skills needed by the procedure, in order to choose the best approach for a given task, leading to the direction recommended by Annex 1 of the GMP: “The utilization of isolator technology to minimize human intervention in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment”.
Preliminary studies performed at our site, in collaboration with certified validation companies, show the installation costs of a cleanroom vs. an isolator can be similar. Conversely, running costs (energy, filters, gowning materials) will be lower by as much as 30% a year with the adoption of isolation technology, compared with a medium size cleanroom with a 4 gloves isolator. This justifies, along with better operator time management, the adoption of isolation technology in ACT, providing the feasibility of the technical and scientific approach is guaranteed.