In 2012, GE Healthcare acquired US production tech firm Xcellerex which expanded the firm’s biomanufacturing offering by adding a single-use bioreactor range and the Flexfactory modular production line system.
But the deal also added an inactivated cell-culture based vaccine for yellow fever, XRX 001, and this week Ontario, Canada-based PnuVax Incorporated announced it has bought the rights to the candidate.
Currently, immunisation against yellow fever is carried out using a live vaccine, PnuVax CEO Donald Gerson told Biopharma-Reporter at BIO in San Francisco this week. “This would be the first inactivated yellow fever vaccine allowing access to groups of people such as babies, the elderly, and people with severe immunodeficiency.”
XRX 001 is a cell-based vaccine, rather than egg-based as with current yellow fever offerings, and made using Vero cells grown on microcarrier beads. Xcellerex had taken the product through Phase I trials before the project was put on hold due to the GE Healthcare acquisition, and had produced the clinical material using a 50L system running at 25L.
“Our eventual target is to scale-up to 2,000L, and we’re already planning the facility to put that in,” Gerson told us. The site will use GE Healthcare Life Sciences FlexFactory biomanufacturing platform but financial details and further details could not be disclosed.
Changing the vaccine paradigm
Gerson, a seasoned veteran in the biopharma and vaccine industries having served as head of vaccine manufacturing at Wyeth, believed that taking a single-use approach to vaccine manufacturing could revolutionise an industry which has seen little change in its processes for decades.
“There are a large number of legacy vaccine products that large pharma companies still make using technologies that were really good in 1962 – I’ve made them all – and as a rule the large companies have not been willing to invest in these products.
“To some extent regulatory agencies have imposed improvement on the environment, equipment and validation steps, but not on the fundamental process,” he continued, adding that a company like PnuVax starting afresh with disposable equipment could drive a re-evaluation of the whole industry.
Parrish Galliher, CTO of upstream bioprocessing at GE agreed, telling us the paradigm shift has already begun as demonstrated by Korea’s SK Chemicals, which makes commercial volumes of licensed seasonal flu vaccines using single-use technology at a 2,000L scale.
“There are vaccine companies already out there building commercial plants now licensed to use single-use technology. The benefits [of single-use systems] are being recognised, and single-use is penetrating the vaccine industry.”
Most of the advantages of using disposable technologies for biopharmaceuticals – faster facility build, reduced capital and operating costs, simplified cleanability etc. – are relevant for vaccine production, he added, as is the elimination of cross-contamination.