With a substantial manufacturing base already locked down in China, CRDMO BioDuro is taking a short jaunt down to Taiwan for its latest drug ingredients production play.
BioDuro, headquartered in California, has set up a new joint venture with long-standing Taiwan-based pharmaceutical ingredient (API) manufacturer Cenra API Solutions. The collaboration will see Cenra’s commercial-scale facility in Taipei folded into BioDuro’s production network, which is split across multiple facilities in mainland China.
BioDuro will bring its early-stage development know-how to the table, with the final venture expected to yield an end-to-end API offering spanning early development through commercial manufacturing, according to a March 4 press release.
Cenra’s campus in Taiwan’s capital, Taipei, is equipped with 10 API production lines and boasts a total reactor volume of more than 350,000 liters, which BioDuro said can support 200 metric tons of drug ingredients output per year.
"By combining BioDuro's integrated CMC expertise with Cenra's nearly six decades of GMP manufacturing excellence and enviable international regulatory history, our joint venture strengthens both companies' global supply chain resilience and minimizes the risks of technology-transfers," BioDuro’s chief executive, Armin Spura, Ph.D., said in a statement.
Taiwan's Cenra API Solutions, registered as Chunghwa Chemical Synthesis & Biotech Company, was founded back in 1964. Cenra became the first API manufacturer in Taiwan to receive FDA sign-off and presently works with customers in more than 50 countries, according to BioDuro’s release.
A little over a year ago, BioDuro strengthened its production foothold in China with the debut of a new peptide synthesis manufacturing facility at its campus in Shanghai.
The CRDMO in its present form emerged when then-early-stage CRO BioDuro merged with contract manufacturer Formex in 2015, expanding its U.S. production presence and maintaining its China research capabilities in parallel.
Up until recently, BioDuro boasted drug product manufacturing in Irvine, where the CRDMO is headquartered. But in January, it completed the sale of its facility there to Forma Life Sciences.
BioDuro stressed that the move “does not change the company’s identity or strategic footprint in the United States,” noting that it remains a U.S.-headquartered company with a dedicated drug product team still onboard in China.
"This divestiture is a strategic step that allows BioDuro to further sharpen our focus on our core strengths in drug discovery and drug substance development and manufacturing," CEO Spura said of the move earlier this year.
Editor's Note: This story has been corrected to clarify that Cenra is registered as Chunghwa Chemical Synthesis & Biotech Co.