GMP Cell Therapy Manufacturing
Translating scientific discovery to clinical-grade products for use in therapeutic trials requires advanced specialised facilities.
Our GMP (good manufacturing practice) laboratories, part of our Keith and Faith Taylor Cancer Research Laboratories, enable us to manufacture and develop new therapeutic products such as CAR T-cells and cancer vaccines for use in clinical trials.
More sterile than an operating theatre, our GMP laboratories ensure we meet the strict safety requirements for human trials. They provide an important step in translating discoveries to treatments and cures.
What’s special about a GMP lab?
- GMP labs are held under positive air pressure to prevent outside (non-sterile) air getting in. The walls have to be reinforced with steel so they can withstand this pressure!
- Air entering and leaving the labs goes through medical-grade HEPA filters which removes over 99.95% of particles ≥ 0.3um.
- We use an air sampler and a particle counter to monitor air in the cleanroom – this identifies the number and size of particles present in the production environment and any viable organisms in the air.
- The suite is regularly cleaned using sterile special cleanroom reagents. Each month we send samples from surfaces and equipment for sterility testing to ensure the environment and product we’re manufacturing pose no infection risk to patients.
- GMP technicians have to dress from head to toe in sterile gowning before entering the suite and follow strict protocols while inside.
- All equipment, supporting infrastructure and operating protocols must be regularly validated and approved by Medsafe, New Zealand’s safety regulator for medicines.
- Every item which is taken into the production clean room has to be sterilised, including flasks, gowns, pens and microscopes.