The CRDMO BioDuro has announced a joint venture with Cenra API Solutions, also known as Chunghwa Chemical Synthesis & Biotech Co. (CCSB), a prominent pharmaceutical chemical manufacturer in Taiwan.
The new collaboration aims to enhance the commercial-scale active pharmaceutical ingredient (API) manufacturing capacity at Cenra's facility in Taipei, Taiwan, integrating it into BioDuro's global network.
The joint venture will leverage BioDuro's expertise in early-stage drug development and integrate it with Cenra's capabilities in commercial-scale GMP API manufacturing.
The collaboration aims to provide global clients with a comprehensive API solution, covering everything from early development to large-scale manufacturing.
The Taipei campus is equipped with 10 GMP API production lines, boasting a total reactor volume of more than 350,000 litres.
The facility can support an annual API output of up to 200 metric tons. It has successfully passed inspections by several major international regulatory agencies, including the US FDA, EMA, Japan's PMDA and Taiwan's TFDA.
"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 minimises the risks of technology transfers," said Dr Armin Spura, CEO of BioDuro.
"This collaboration allows us to provide customers with truly integrated services and a drug substance solution that spans discovery chemistry, process R&D, regulatory starting materials, advanced intermediates and clinical-to-commercial-scale API production, both inside and outside mainland China, accelerating the advance of innovative therapies to market, for patients worldwide."
"BioDuro serves more than 1500 global customers annually with industry-leading R&D and manufacturing capabilities," added Wayne Hsiao, President of Cenra API Solutions.
We are excited to join forces to deliver highly integrated solutions and greater value to customers around the world.