Prestige Biologics, a Contract Development and Manufacturing Organization (CDMO) company specializing in biopharmaceuticals, announced on the 19th the establishment of a ‘US Biosecurity Act Response TFT’ to expand its entry into the US CDMO market.
CDMO production typically requires discussions on technology transfer and GMP (Good Manufacturing Practice) certification at least one year in advance. This decision was made swiftly in response to a surge in inquiries and factory requests seeking CDMO companies to replace Chinese CDMO firms.
This TFT focuses on absorbing the volume from Chinese CDMO companies, including Wuxi Biologics (hereafter Wuxi), which the US has restricted transactions with. The strategy is to aggressively target the approximately 1.4 trillion KRW market gap left by Wuxi in the US, leveraging the TFT’s sales capabilities and technical expertise.
The TFT will strengthen business competitiveness through △forming a dedicated sales team for Chinese CDMO clients in the US △hosting conferences related to single-use technologies △applying for US cGMP certification.
The company explained that the US-dedicated TFT has been staffed with balanced talent to lead growth in expertise and organization in the US CDMO market and single-use technology. Yang Jae-young, Executive Director, who graduated from Seoul National University’s Department of Microbiology, worked as a researcher at Allergan in the US, and recently secured orders from Celltrion as Prestige Biologics’ head of technical sales, will lead this TFT. Additionally, personnel with extensive experience in domestic and international CDMO and GMP certification, including technical and sales specialists, as well as US-educated planning team members, will actively support the US market entry.
Hosting conferences on scale-out technology based on single-use (Single Use; disposable plastic bags), which is most similar to Wuxi’s approach, is also a role of the TFT. Wuxi has gained attention for increasing production efficiency and yield by flexibly scaling production through adding multiple 2,000-liter single-use bioreactors using scale-out technology. This is analyzed as an opportunity factor for Prestige Biologics, which implemented a factory based on a single-use system from the start.
The schedule for US GMP certification will also be expedited. Prestige Biologics operates a state-of-the-art factory meeting international standards, with experience in Korea’s MFDS KGMP and Europe’s EU-GMP certifications. Recently, it completed trial production of the Avastin biosimilar HD204 from its parent company, Prestige Biopharma, at Plant 4 and is preparing for US cGMP certification. Based on its know-how from passing the stringent European GMP certification, the company plans to proceed quickly with US GMP certification according to customer demands.
A company representative stated, “Prestige Biologics is a global CDMO company equipped with the production scale, certification capabilities, and productivity that clients desire. With sufficient competitiveness compared to Chinese companies, we will respond swiftly and proactively to seize the emerging opportunities and absorb large-scale volumes.”
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
