The US$7m investment will triple its cleanroom capacity for manufacturing single-use products for the biopharmaceuticals industry
Global demand for single-use products is predicted to exceed US$3bn as biologic producers move from stainless to disposables
GE Healthcare’s Life Sciences business, a solutions provider to the biotech industry, is spending US$7m on its single-use technology manufacturing facility in Westborough, MA, US.
The expanded site will manufacture a range of single-use products, including cell growth bags, based on a newly developed film platform resulting from GE’s strategic alliance with Sealed Air.
With global demand predicted to exceed US$3 billion by 20201, single-use bioprocessing technologies are playing an increasingly vital role to biologic producers, helping them accelerate capacity expansion and improve productivity to support faster delivery of targeted therapies to patient populations.
GE’s tripling of production-dedicated cleanroom capacity at Westborough and upskilling of over 300 personnel will enable the business to meet increasing market demand well into the future. The current facility and quality management system are certified against ISO 9001:2008, and all handling is performed to the standard of an ISO 14644-1 cleanroom class 7 environment.
In addition, the installation of automated production lines will drive manufacturing efficiency and improved process controls to ensure product quality and consistency.
The new film platform, developed in collaboration with Sealed Air expressly for biomanufacturing, supports exceptional cell growth and application robustness.
It will be used in the manufacture of all single-use products at the Westborough site.
In parallel, GE Healthcare Life Sciences has established an enlarged extractables and leachables (E&L) analytical laboratory in Uppsala, Sweden.
This laboratory will support in-depth characterisation of the potential impact of E&L compounds across all production processes and future novel single-use technology materials.
Jan Makela, General Manager, BioProcess at GE Healthcare’s Life Sciences business said: 'Biopharmaceuticals are complex to make, requiring a dependable, consistent supply of high quality manufacturing technologies.'
He added: 'The launch of our new film with Sealed Air, the investment in single-use manufacturing in Westborough, MA and the enlarged E&L capabilities in Sweden confirm our on-going commitment to minimising risk and assuring security of supply for our customers around the globe.
1 BCC Research, Single-Use Technologies for Biopharmaceuticals, 2015.