The $350m (€315m) investment is the latest spend by Pfizer in its biologics network, and comes just days after the firm broke ground on a $200m clinical biomanufacturing facility in Andover, Massachusetts.
The new facility in Hangzhou Economic Development Area (HEDA), China will make biosimilar products for the local market once production begins in 2018, Pfizer spokesperson Loucineh Mardirossian told Biopharma-Reporter.
“Not only will this Biotechnology Centre ensure the local production of high-quality, affordable biosimilar medicines that will benefit patients in China and across the world,” she said, but “it will also help contribute to the continued development of the biotechnology industry in China and support nation healthcare reforms.”
Production capacity is set to be 25 million vials per year, in the first phase, she added.
GE’s 'turnkey approach'
The site itself will use multiple 2,000L single-use bioreactors with associated downstream systems implemented through a strategic partnership with life sciences technology firm GE Healthcare, which is managing the facility set-up from conception to completion on behalf of Pfizer.
“GE Healthcare is providing a complete turnkey approach to Pfizer, including proof of concept, transportation and construction of the KUBio [GE’s modular facility platform], manufacturing process optimisation, validation of the facility and training of Pfizer’s manufacturing professionals in China,” GE’s Saara Nordenström told this publication.
She added the approach was similar to GE’s partnership with JHL, which saw the opening of the world’s largest modular cGMP biomanufacturing facility in Wuhan last month.
GE boasts its KuBio modular platform can significantly reduce a facility’s build time of 18 months, compared to the approximate three years for a traditional plant. “This rapid deployment translates to reduced risk and faster time to market,” Nordenström said.
But, she continued, the platform is customable, and thus Pfizer’s KUBio design differs from JHL’s and includes the additional feature of a fill/finish unit for packaging of the final product, constructed in the same off-the-shelf modular approach as the main KUBio.
Pfizer and Single-Use
Like the Andover investment, this latest news shows further support from Pfizer for single-use technologies within its own biologics network.
Mardirossian said the facility will be equipped with disposable technologies, and while it is not 100% single-use, "this Global Biotechnology Center in Hangzhou represents the most significant investment in single use technology within Pfizer to date."
She continued: "Pfizer is currently investing in GE technologies for the manufacture of biopharmaceuticals for our innovative development lab in Andover, Massachusetts. Combined with Hangzhou, and another new investment in GE technologies that we are making at our Global biotechnology site in Grange Castle, Ireland, Pfizer will have a fully integrated and standardized biotechnology development and manufacturing capability in one platform."