With significant manufacturing sites already under lockdown in China, CRDMO BioDuro is on a short trip to Taiwan for its latest pharmaceutical raw material production activities.
California-based BioDuro has formed a new joint venture with Cenra API Solutions, a long-established Taiwan-based pharmaceutical ingredient (API) manufacturer. The partnership will bring Cenra’s commercial-scale facility in Taipei into BioDuro’s production network, which is split across multiple facilities in mainland China.
According to a March 4 press release, BioDuro will leverage its early-stage development know-how, and the final project is expected to provide an end-to-end API from initial development to commercial production.
Cenra’s campus in Taiwan’s capital Taipei is equipped with 10 API production lines with a total reactor volume of more than 350,000 liters, which BioDuro says can support annual production of 200 tons of pharmaceutical raw materials.
“By combining BioDuro’s integrated CMC expertise with Cenra’s almost 60 years of excellent GMP manufacturing and enviable international regulatory history, our joint venture will strengthen the resilience of both companies’ global supply chains and minimize technology transfer risks,” BioDuro CEO Dr. Armin Supra said in a statement.
Cenra API Solutions is part of Taiwan’s Chunghwa Chemical Synthesis & Biotech Company, founded in 1964. According to a BioDuro release, Cenra became the first API manufacturer in Taiwan to receive FDA approval and currently works with customers in more than 50 countries.
A little more than a year ago, BioDuro strengthened its production footprint in China by debuting a new peptide synthesis manufacturing facility on its Shanghai campus.
CRDMO in its current form was created in 2015 when BioDuro, then an early-stage CRO, merged with contract manufacturing company Formex to expand its manufacturing presence in the U.S. and maintain research capabilities in China in parallel.
Until recently, BioDuro boasted drug manufacturing in Irvine, where CRDMO is headquartered. However, in January the company completed the sale of its facilities there to Forma Life Sciences.
BioDuro stressed that the move “does not change the company’s identity or strategic location in the United States,” noting that the company remains headquartered in the United States and has a dedicated pharmaceutical team in China.
CEO Supra said of the move earlier this year, “This sale is a strategic step that will enable BioDuro to further focus on our core strengths in drug discovery and active pharmaceutical ingredient development and manufacturing.”
