BioDuro, LLC, a global CRO leader focused on preclinical chemistry, biology, and fully outsourced integrated drug development services for pharmaceutical partners, announced the merger of its US operations with Formex, LLC, a leader in pharmaceutical API formulation, development and cGMP manufacturing, with turnkey 44,000 sf manufacturing facility in San Diego, California.
Under the terms of the agreement, the combined companies will operate under the corporate structure of BioDuro, LLC, headquartered in San Diego, California. The formulation and manufacturing group at Formex will continue to operate in San Diego, as a wholly-owned subsidiary of BioDuro.
BioDuro's global operations include a 100,000 sf facility in Beijing, focused largely on biosimilars, synthetic, medicinal and computational chemistry, and a 92,000 sf state of the art facility in Shanghai, that houses BioDuro's drug screening, DMPK, and integrated biology, as well as GLP bioanalysis, PK/PD, biomarker and translational research. The combined teams of highly experienced staff, with a 1:4 ratio of PhD to non-PhD scientific staff, have successfully managed many drug discovery and development programs for pharma partners, including repurposed drugs, biosimilars, and novel therapeutic programs. With the addition of Formex, BioDuro gains access to a 44,000 sf, purpose built cGMP manufacturing facility in San Diego, with proven expertise in formulation, development, and manufacture of drug product, using advanced and proprietary technologies to enhance bioavailability of poorly soluble compounds, to provide seamless translation of high value clinical candidates developed by BioDuro's preclinical group, into more efficacious clinical trial material (CTM), using gram-scale quantity of API for initial formulation, while providing scalable operations that will provide clients with Phase I-III and commercial manufacture of drug product.
Leading the merger, is BioDuro's Chairman, Dr. Masood Tayebi, who was the original founder of BioDuro in 2005. Since then, Dr. Tayebi's continued investments in the healthcare/biotech sector have resulted in world class companies in CRO and CMO services, such as Molecular Response and Formex. The executive team for the merged companies will comprise of Cyrus K. Mirsaidi, current CEO at Formex, who will lead as President and CEO of the combined entities, and long term BioDuro management, Dr. TJ Deng, who will continue as General Manager, China Operations.