Cytiva and Germfree unveil collaboration to advance modular manufacturing of novel biotherapeutics
Marlborough, Massachusetts and Ormond Beach, Florida – September 10, 2019 – Cytiva 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 2019-2025i. 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 Cytiva’s proprietary design and equipped with FlexFactory, Cytiva’s integrated single-use biomanufacturing platform. This will be the latest addition to Cytiva’s KUBio prefabricated manufacturing facility offering.
Germfree modular bioprocessing environment (credits: Germfree)
“With Germfree, we will bring reliable and scalable technologies for modular solutions to the gene therapy space,” says Olivier Loeillot, General Manager, BioProcess at Cytiva. “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 Cytiva 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 Cytiva 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 Cytiva’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 Cytiva’s FlexFactory biomanufacturing platform.
- In 2018, Lonza announced an agreement with Cytiva, under which Cytiva 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 Cytiva’s KUBio.
Sources:
i Bloomberg (August 2019) Global Cell and Gene Therapy Market to Reach $11.96 Billion by 2025
About Cytiva
Cytiva helps therapy innovators, researchers and healthcare providers accelerate how precision diagnostics and therapies are invented, made and used. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE (NYSE: GE). With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, Cytiva helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world. Visit our website https://www.gelifesciences.com/about-us for more information.
About Germfree
Germfree creates environments that serve life science innovation and advance global health. Germfree designs and manufactures flexible cGMP-compliant cleanroom buildings and high-containment facilities which are process or containment-ready upon deployment. Our facilities are designed to integrate with Germfree’s core equipment including our lines of interchangeable laminar flow hoods and containment equipment. Established in 1962 Germfree’s leading-edge fabrication technology, engineering teams and subject-matter experts are located at our 173,000 square foot (16,000 square meter) US manufacturing plant. Visit our website https://www.germfree.com for more information.