- Drugmakers in China and India, anticipating greater demand for biologic medicines in their home country, are tapping automated biomanufacturing technology from GE Healthcare to more quickly ramp up production.
- Clover BioPharmaceuticals, a clinical-stage Chinese biotech, is the latest to ink an agreement with the healthcare arm of the industrial conglomerate, announcing it will install the so-called FlexFactory at a new facility being built in Zhejiang, China.
- Based on single-use bioreactor bioreactor technology, GE's FlexFactory is designed to manufacture monoclonal antibodies and vaccines under GMP standards. The platform installed at Clover's facility will consist of two 2,000-liter bioreactors and, according to the companies, will be up and running later this year.
Long known for prowess in mass-producing cheap copycat medicines, Chinese and Indian drugmakers have more recently aimed at climbing the value chain to manufacture novel drugs and biologics.
China's government, in particular, has made innovation in biopharmaceuticals a priority, clearing some of the regulatory hurdles that traditionally stood in the way for manufacturers — both foreign and domestic.
Making the kind of advances that China envisions, though, will require a similar jump in manufacturing capabilities. Biologics and cell therapies like CAR-T are more complex than the small molecule drugs Chinese companies are accustomed to producing.
Clover, along with several other Chinese biotechs, have turned to GE and its FlexFactory platform to help kick start that process.
"GE's FlexFactory represents the latest in biomanufacturing technologies, and it will help us establish flexible production capacity quickly, while fulfilling good manufacturing practices (GMP) requirements," said Peng Liang, Clover's co-founder and president, in a statement.
That GMP aspect is an important one. As an industry, Chinese and Indian manufacturers have struggled to maintain GMP production standards, attracting the notice of inspectors from the Food and Drug Administration.
GE's FlexFactory operates as an automated system and its single-use technology eliminates much of the cleaning and contamination risk from multi-use bioreactors.
Asides from Clover, BeiGene Ltd., Shanghai-based Cellular BioMedicine Group Inc. and Taiwanese JHL Biotech have all announced plans to use GE's technology in recent years. Last May, Dr. Reddy's became the first Indian drugmaker to install the FlexFactory platform.
Domestic companies are also building up single-use bioreactor capacity. Wuxi Biologics Inc., for example, announced in December it had started manufacturing operations at its new 500,000 square-foot facility in Wuxi city. The site boasts 30,000 L of bioreactor capacity, spread across two 1,000 L bioreactors for perfusion processes and 14 2,000 L bioreactors for batch cell cultures.