BD upgrades laboratory in Suzhou

Medical technology company BD announced on Friday that its laboratory in Suzhou, Jiangsu province, has been upgraded to BD Pharmaceutical Systems — Greater Asia Integrated Technical Center after the facility was certified by major certification systems, including Food and Drug Administration registration.

The move is aimed at better assisting Chinese biopharmaceutical enterprises that utilize BD's medical packaging materials — such as prefilled syringes and auto-injectors — for international expansion.

With a decade of experience, the facility previously focused on the Chinese domestic market and serving local needs.

BD stated that the transformation of the facility, one of a kind in the Asia-Pacific region in the company's global network, marks a milestone in its commitment to the China market and its deepened localization strategy in the country.

Offering end-to-end services covering pharmaceutical product development, market entry and full life-cycle support for clients, BD — with a presence of nearly three decades in the China market — said the upgrade is expected to accelerate research and development of drug-device combination products, facilitate global regulatory submissions and enhance quality management for pharmaceutical enterprises in China.

Eric Liu, vice-president of R&D, BD Greater Asia, said the upgraded facility will be an integrated part of BD's global research and development network, an excellent platform to engage local customers in Asia, and will help drive service and innovation to the next level through collaboration with local customers.

Industry insiders said that the biopharmaceutical market in China is undergoing robust development, and is at a critical stage in the transformation from scale expansion to innovation-driven development.

"By the end of this year, our forecast is that the overall market size of the China biopharmaceutical industry will reach around 1.2 trillion yuan ($167 billion). Such a market size will account for 18 percent of the global market," said Jiang Wei, vice-president of Pharmaceutical Systems of BD China.

Cedric Leprince, senior global business director of BD Pharmaceutical Systems, said that against such a backdrop, the company intends to bring the most innovative and advanced solutions to support growth in the domestic market, and support the strategic intent of Chinese enterprises to go overseas, including exploring opportunities in Europe and the United States.

"Chinese biologics enterprises are leading and reshaping the pharmaceutical market today. It provides a great opportunity for our company to stay in close contact with them," Leprince said, adding that China is one of the fastest-growing markets for BD in terms of pharmaceutical systems.

Pauline Yu, CEO of Shenzhen, Guangdong-province-based Hybio Pharmaceutical Co Ltd, said the upgrade of the BD facility will enhance their efficiency in critical areas, such as global R&D, testing and registration submissions.

"Its engineering verification system, compliant with US FDA standards, and the company's multidimensional simulation verification capabilities are expected to assist our drug-device combination products in GLP-1 (glucagon-like peptide) series in efficiently meeting FDA review requirements, facilitating our continued expansion in the US market," Yu said.

Luye Life Sciences Group has its products and services network in more than 80 countries and regions around the world. It has more than 10 new drugs undergoing registration and clinical research in the US, Europe and Japan, among other markets.

Xue Yunli, senior vice-president of Luye Life Sciences, applauded the upgrade of the BD facility as it not only expands its testing capabilities, but also secures authoritative good manufacturing practices certification.

"Also, its flexible service model aligns with our diverse R&D pace and needs, enabling us to obtain precise technical support at various stages of product development," Xue said.

The upgrade of the BD facility also touches upon more comprehensive service portfolios, which include global-standard testing in packaging compatibility and combination product functionality, and flexibility with customized solutions, such as offering small-batch assembly services, co-development and tailored pharmaceutical packaging solutions.