GE Healthcare will provide its proprietary design work for the facility, alongside its FlexFactory single-use biomanufacturing platform, while Germfree will provide process-ready cleanroom facilities to round out the offering.
A spokesperson for GE Healthcare told us that the solution will include a biosafety level 2 (BSL-2) environment design, which is suitable to be paired with the company’s biomanufacturing platform for gene therapies.
Together, a platform will be developed that will increase ‘capacity and capability’ in the gene therapy market, the companies stated.
A spokesperson for GE Healthcare told us that the technology can be scaled up to meet customers’ needs: “This good manufacturing practice compliant solution will allow manufacturers of biotherapeutics to expand their capacity (scale-out/scale up) through clinical and commercial manufacturing. The modular design will allow customers to expand by adding new modules as needed.”
The development comes as larger companies in the gene therapy have taken the step to build out their own gene therapy manufacturing capabilities.
Iovance recently increased its clinical and commercial capabilities with a $75m (€67.3m) investment and Pfizer recently chose to do the same ahead of the start of a Phase III clinical trial for its Duchenne muscular dystrophy gene therapy candidate.
GE Healthcare and Germfree’s manufacturing offering comes amid a wider regenerative medicine market that is predicted to grow at compound annual growth rate (CAGR) of 23.8%.
The spokesperson told us the technology would be available by the end of October.
