GE launches range of 'off the shelf' MAb facilities
The facilities – known as KUBio – are 1,200sqm, current good manufacturing practices (cGMP) compliant units that combine GE’s range of single-use technologies and purification medias with manufacturing platforms the firm gained with the acquisition of Xcellerex.
Olivier Loeillot, general manager of enterprise solutions, told in-Pharmatechnologist.com that GE will be making the facilities in collaboration with firms it partnered with under the billion dollar biomanufacturing investment programme it launched in September last year.
“The modular facility sections of the KUBio are manufactured and fitted out prior to shipping, in Germany by our subcontractor M+W. As you will be aware we are already in an alliance with M+W a leading global engineering, construction and project management company, so this is a strong fit of expertise.”
He added that the “single-use components of the production line are manufactured at GE Healthcare’s global manufacturing sites in Westborough and Sweden. The KUBio arrives at a customer’s location in modular sections which are assembled onsite, at which point the production line components are also installed.”
GE claims that KuBio plants – which will initially be configured for monoclonal antibody production - can be fully operational in between 14 and 18 months, which it says is a significant time saving compared with the 24 to 36 months it takes to set up a traditional biomanufacturing facility.
Loeillot declined to say how much the new plants would cost, on the basis that each of the modular units is unique and bespoke for each customer. However, he did indicate that the facilities would be cheaper than traditional set ups.
“Depending on the location, installing a KUBio compared with a traditional stainless steel facility could reduce capital investments by up to 30 per cent.”
He also claimed that when operational, each facility will have the capacity to produce over 100kg of monoclonal antibody (MAb) each year.
GE has already had some expressions of interest in the KUBio plants according to Loeillot, who said: “We’re in talks with a number of interested parties from pharmaceutical companies wanting to expand production capacity in new locations, through to governments wanting to develop in-country manufacturing capability.”
