GE Healthcare Life Sciences and Germfree are joining expertise to develop a fully integrated, expandable manufacturing solution for emerging biotherapeutics, including gene therapy.

Current market indicators predict a compound annual growth rate of more than 36% in the cell and gene therapy market during 2019-2025 i. With more than 700 cell and gene therapies currently in clinical trials, demand exceeds supply. The collaboration with Germfree represents a significant contribution to increase capacity and capability in the gene therapy market.

The manufacturing solution will feature a Germfree modular bioprocessing environment based on GE Healthcare’s proprietary design and equipped with FlexFactory, GE Healthcare’s integrated single-use biomanufacturing platform. This will be the latest addition to GE Healthcare’s KUBio prefabricated manufacturing facility offering.

“With Germfree, we will bring reliable and scalable technologies for modular solutions to the gene therapy space,” says Olivier Loeillot, General Manager, BioProcess at GE Healthcare. “Modular capabilities can reduce timelines, lower capital and operating costs, as well as give flexibility for potential expansion,” says Olivier Loeillot.

Carol Houts, Germfree’s Vice President Quality and Business Strategy says: “The collaboration with GE Healthcare provides rapidly deployable process-ready cleanroom and bioprocessing platforms to an industry where resource constraints limit the progress of emerging biotherapeutics. Germfree has longstanding global expertise in producing biocontainment environments and biotherapeutics cleanroom solutions.”

Germfree is a biotech company globally recognized for its pioneering manufacturing of process ready cleanroom facilities. The solution developed by Germfree and GE Healthcare will provide tools and technology for biomanufacturing in an integrated and flexible Good Manufacturing Practice (GMP) environment. This is expected to speed novel therapies to market and accelerate the accessibility of personalized medicines.

This is how GE Healthcare’s modular solutions transform the global ecosystem of biomanufacturing:

• To date, four KUBio facilities and 63 FlexFactory platforms have been acquired by manufacturers of biopharmaceuticals.

• In 2019, Bayer broke ground on a site in California to make biologic therapies using GE Healthcare’s FlexFactory biomanufacturing platform.

• In 2018, Lonza announced an agreement with GE Healthcare, under which GE Healthcare will develop a biologics center featuring a KUBio biomanufacturing facility. The center is expected to be operational in 2020.

• In 2016, Pfizer announced an investment to establish a biotechnology center in China based on GE Healthcare’s KUBio.

Sources:

i Bloomberg (August 2019) Global Cell and Gene Therapy Market to Reach $11.96 Billion by 2025

By GE Healthcare Life Sciences