Cell therapy and gene therapy are the buzz words most commonly heard in modern laboratories.
In yester year you would have entered a laboratory to find powder handlers and pill making machines along with fume cupboards and chemical storage devices and scientists creating pharmaceutical and performing microbiological testing.
The laboratories of today are tightly controlled and validated cleanroom facilities filled with state-of-the-art clean air technology in the form of class II microbiological safety cabinets, isolators all ensuring the air within the work space is clean of any particles.
Air coming into and out of the cleanroom is filtered as well as the air passing into and out of the equipment within. Laboratory personnel must pass through a rigorous entry process including wearing multiple layers of protective clothing and sometimes such lengths as wet showers. All to ensure the cleanliness of the facility.
Grade H14 HEPA filters are used to ‘clean’ the air entering and exiting controlled facilities as well as within work zones within
equipment such as class II microbiological safety cabinets. H14 HEPA filters are used to remove 99.995% of particles down to size 0.3 microns.
The air within a class II microbiological safety cabinet is pulled in via the front aperture/sash opening, passing below the work space and behind the back wall of the cabinet. The air is now within the engine of the cabinet and is pushed down through the main HEPA filter and into the work space by the main motor. This air now within the work space is clean and passes over the apparatus and samples within without causing contamination.
The air is now deemed as dirty, having passed over the materials within the cabinet and so the air is drawn down beneath the work surface to re-enter the pattern of air entering via the front aperture. In addition, 30% of air is expelled via the exhaust HEPA filter each time the air moves into the engine of the cabinet, thus allowing air to enter via the front aperture and maintain the cycle of cleaning the air within and only expelling clean air back into the laboratory.
The requirement to maintain acute cleanliness is due to the high-profile nature of the cell therapy being performed by the modern-day scientist.
CAR-T cell therapy is the process whereby T cells are extracted from a patient’s body and modified to seek and destroy cancer cells by implanting a chimeric antigen receptor (CAR) in the cell.
T cells are a type of white blood cell which move round our bodies searching for abnormalities and infections. They play a huge part in our immune response to any infection or disease including cancer. There are two types of T cell ‘helper’ and ‘killer. Killer cells, seek out and destroy infected cells whereas helper cells stimulate our immune system to respond to the infection or disease.
These CAR-T cells are produced in the laboratory and multiplied before being transfused back into the patient’s body. The necessity to keep these cells ‘clean’ is paramount and rely on solid clean air technology to prevent patient infection during transfusion.
CAR-T cell therapy has been used by cancer research bodies throughout the world in ground-breaking work including that of the Cancer Research Institute who are leaders in the fight against paediatric cancers.
Controversially, stem cell research is also an increasingly common form of laboratory work today. Stem cells can be used to grow a ‘new’ trachea in progressive regenerative medicine.
We at Biopharma Process Systems (BPS) understand the stringent validation requirements of cleanroom facilities as well as clean air equipment which must be maintained to meet the expectations of MHRA. BPS are the ideal partner who understand and can support document preparation and execution to maintain a clean laboratory.