BeiGene Ltd, a global oncology company, announced on Monday the completion of its antibody-drug conjugate production facility in Guangzhou, capital of Guangdong province, demonstrating its commitment to the industrialization of innovative medicines.
The launch of the ADC facility marks a major step forward in boosting the company's research and development capabilities, expanding manufacturing capacities and empowering innovative development of the biopharmaceutical industry, the company said.
The 58,000-square-meter ADC facility is expected to emerge as BeiGene's flagship and core base for ADC R&D and production globally.
Comprising two primary workshops and associated ancillary facilities, the initial stage of the project encompasses antibody conjugation, ultrafiltration purification, aseptic filling and lyophilization production lines.
Moreover, the facility boasts dedicated quality control analysis laboratories, along with sci-tech manufacturing and process development capabilities, to facilitate the technical transfer and commercial manufacturing of ADCs, BeiGene added.
Scheduled to commence production in the second quarter, the facility is expected to scale up its production capacity more than twofold to cater to the ever-growing demand for innovative solutions in the pharmaceutical market.
In July 2023, BeiGene and DualityBio, a Chinese pharmaceutical company, entered into an exclusive collaboration agreement, granting BeiGene the option for a global clinical, manufacturing and commercial license for preclinical ADC therapy for patients with select solid tumors.
With the official inauguration of the ADC campus, the new facility will provide clinical and commercial production support for preclinical medicines and more ADCs, jointly advancing the R&D and market launch of innovative medicines, BeiGene said.
The company will continue to leverage rich resources and its talent pool in Guangzhou and the Guangdong-Hong Kong-Macao Greater Bay Area — which plays a pivotal role in the biopharmaceutical industry — to build a biopharmaceutical ecosystem, said Wu Xiaobin, president and chief operating officer of BeiGene.
"We aim to accelerate the R&D, manufacturing and commercialization of innovative medicines, providing more accessible and affordable innovative therapies to patients worldwide," Wu said.
As the global ADC market is expected to grow to $64.7 billion by 2030, BeiGene is well prepared to produce a wide range of innovative medicines by establishing a comprehensive and advanced manufacturing infrastructure, said Kyu-Sung Lee, senior vice-president and global head of technical operations and manufacturing at BeiGene.
The company's manufacturing capabilities range from small-scale clinical trials to large-scale commercial production, helping ensure a seamless transition from research to the market, Lee said.
"Moreover, with a strong pipeline of innovative drugs, including ADCs and other biologics, our R&D capabilities are a key advantage in drug manufacturing," he added.
By harnessing key technology operations and developing in-house manufacturing capabilities, BeiGene has built a diverse global supply network, with its production sites already built in Guangzhou and Suzhou, Jiangsu province, as well as New Jersey in the United States.
"The global supply network helps the company effectively cater to the global demand for pharmaceutical commercialization and clinical trial supplies, powering the rapid advance of our highly differentiated value chain across the global industry," he said.
[來源: ChinaDaily]