CELL & GENE THERAPY CLEANROOMS
Cell and gene therapies are both forms of regenerative medicine. Cell therapy involves transferring live, intact cells into a patient to lessen or cure a disease. The cells may be from the patient (autologous) or from a donor (allogeneic). Gene therapy involves transferring genetic material into a patient to change how a single protein or group of proteins is produced by the cell.
These are relatively new treatment options, but many healthcare professionals are optimistic about the safer, more targeted, less invasive way to treat serious illnesses.
All that said, the various processes that go into developing cell and gene therapies require a controlled cleanroom environment. Tasks like cellular engineering and genetic engineering, growth, and purification all require stringent cleanliness standards, so that their results can be safe, effective, and repeatable.
Something that can jeopardize that environmental control? The various types of equipment housed within the space. Below, we’ll talk about cell and gene therapy cleanroom equipment, what risks it can pose, and what steps you can take to mitigate those risks.
RISKS ASSOCIATED WITH CELL & GENE THERAPY CLEANROOM EQUIPMENT
While designing a cell and gene therapy cleanroom, it’s important to consider the pieces of equipment that are required for your operations and how they may affect the surrounding cleanroom environment. Many pieces of cell and gene therapy equipment can emit heat and contaminants, which presents a bit of a challenge during the design process. Depending on the risk they carry, you may need to determine if this equipment should be located in a classified or external support area, or if other accommodations need to be made to ensure a high level of safety and control.
Here are a few of the main risks associated with cell and gene therapy cleanroom equipment, along with considerations you should take to mitigate them:
Equipment material – Equipment should be manufactured using non-shedding materials that can withstand sanitation and decontamination practices, which could include exposure to vaporized hydrogen peroxide (VHP) and other biocides. Materials should also have low electrostatic properties in order to reduce particle adherence.
Equipment surface – All equipment surfaces should be smooth, with no joints, cracks, or crevices for contaminants to accumulate. Also, surfaces that come into contact with products and consumables should be non-absorbent and non-reactive.
Particle emission – Oddly enough, the equipment used to safely carry out cleanroom operations can be a contributor to particle emission as well. For these types of equipment, you may need to either find an external storage area, conduct additional sanitation procedures, or boost your filtration efforts.
Heat gain – Many pieces of cell and gene therapy cleanroom equipment can increase the temperature in cleanrooms, which means you may need to include additional cooling systems and account for the heat loads in the design. Also, when writing a user requirement specification (URS), you should include details for what equipment will be located in which area so that heat load calculations can be made easily.