Isolator Design for Cell Therapy Facilities
Jan 20, 2020
Allan Bream, Bioprocess Specialist at CRB, was recently featured in Pharma’s Almanac, with an article entitled, “Isolator Design in Cell Therapy Facilities.”
Cell and gene therapy manufacturing must be performed under aseptic conditions and with good aseptic handling practices to ensure patient safety. The use of isolators can help address this critical need, but designing isolators for advanced therapy medicinal product (ATMP) processes can be challenging.
Allan addresses some of the following challenges that designing isolators for ATMP processes can present (excerpts below):
Rich Pipeline Driving Market Growth and Capacity Demand
The cell and gene therapy segment of the pharmaceutical market is evolving at lightning speed. Only a few years ago, these treatments comprised the smallest fraction of products in the clinical pipeline.
Facility Design Challenges
Designing new facilities for cell therapy manufacturing is a challenging task. Commercialization remains in the nascent stage, with only a few facilities constructed to date. Production experience thus far has largely been limited to the laboratory scale, and, particularly for cell therapies, most processes involve highly manual operations.
Moving to Isolators
All cell therapies cannot be terminally sterilized. Therefore, very rigorous quality control is essential in their production, regardless of the batch size — whether it is a patient-specific autologous therapy or a large-volume batch of an allogenic, off-the-shelf product. The entire production process must be performed aseptically, including extensive in-process and final product quality control testing, in a manner that ensures sterility and efficacy with a high degree of certainty.
The Need for Customization
The use of isolators presents its own set of challenges, however. Isolators have traditionally been designed for aseptic fill-finish and non-aseptic potent compound manufacturing operations, not for small-volume, manual cell and gene therapy production.
Regulatory Uncertainty
Given the nascent nature of cell and gene therapies, regulatory agencies have only begun to focus on the specific requirements for these products with respect to development and manufacturing.
The Ultimate Goal: Closed Processes
While there is much that can be done to standardize equipment use for cell and gene therapy within an isolator environment, which would then allow for more standardization of isolator designs, the use of isolators is not the ultimate goal for ATMP production.
