Sparx Therapeutics to Build Commercial Antibody Manufacturing Facility in China

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

On July 8, 2021, Sparx Therapeutics, a US-headquartered, research-based development-stage biopharmaceutical company, announced its plan to build a 1.2 million-ft2 manufacturing facility in Yangzhou, China, bringing it closer to its goal of becoming a commercial-stage biopharmaceutical company.

Sparx's Yangzhou manufacturing site will be located east of Shanghai. As part of its plans, the company intends to build a 400,000-ft2 current good manufacturing practice (CGMP) cleanroom on a 10-acre parcel of land. The facility will have a total bioreactor capacity of 80,000 liters housed in separate cleanroom suites, with the capability to support the manufacturing needs of five commercial products in parallel as well as the chemistry, manufacturing, and controls needs for more than 12 programs in clinical trials at various stages of development. The company expects the facility to be operational by the end of 2022.

Sparx specializes in multi-specific antibody and antibody drug conjugate (ADC) discovery platforms, leveraging artificial intelligence to drive its proprietary target mining engine, which allows identification of cellular targets that can best be used for optimal and synergistic biological activity. The company’s target discovery platform combines an integrated multi-component SAILING antibody optimization system with four ADC technologies to markedly improve the success rate of empowered antibody drug development.

"The global pharmaceutical market is growing with strength and empowered antibody discovery is taking the center stage in driving these efforts," said Gui-Dong Zhu, CEO of Sparx, in a company press release. "The current [C]GMP pilot plant is not able to meet our development needs, and the planned facilities, with a total bioreactor capacity of 80,000 liters, will provide sufficient quantities of drug substances and drug products to support preclinical and clinical development and, ultimately, commercial launch."

Source: Sparx Therapeutics