BioDuro Launches as Unique Contract Research & Drug Manufacturing Organization

BioDuro, LLC recently announced the formal launch of the BioDuro organization, having merged with Formex to become an end-to-end solution provider for integrated drug discovery and development, API synthesis and optimization, formulation and cGMP manufacture of drug products.

“I am thrilled to introduce this truly unique organization to the global contract research and manufacturing markets,” said Cyrus K. Mirsaidi, President and Chief Executive Officer, BioDuro. “We have delivered on a strategic objective to establish a contract organization that meets market demand for full-service drug discovery, development, formulation, and manufacturing to increase probabilities for drug candidate success. We have made significant investments in the combined company for expansion, training, and highly differentiated platforms, and are committed to grow and increase our service offerings both organically and through acquisitions to broaden our value offerings for our partners and clients.”

BioDuro recognizes the increasing pressures on the pharmaceutical industry to reduce discovery and development time and cost, and offer ways to improve weak success rates while speeding the course of development.

BioDuro, a US-owned research and development contractor founded in 2005, with laboratories in San Diego, Beijing, and Shanghai, is a full-service preclinical research and clinical development service provider that offers discovery and development solutions from lead identification and optimization through to dosage form development and manufacturing. Until the company’s recent merger with Formex, BioDuro focused primarily on preclinical discovery, and early clinical development of pharmaceuticals.

With the addition of Formex, customers gain access to a 44,000-sq-ft, purpose-built cGMP manufacturing facility in San Diego, with proven expertise in formulation, development, and manufacture of drug product. Using advanced and proprietary technologies, the newly merged companies offer services to enhance the 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 offer clients Phase I-III clinical development as well as clinical and commercial manufacture of drug product.

BioDuro’s global operations include a 100,000-sq-ft facility in Beijing, focused largely on biosimilars, synthetic, medicinal and computational chemistry, formulation development, and analytical support for conducting bioequivalence studies in support of CFDA filings, and a 92,000-sq-ft state-of-the-art facility in Shanghai, which houses BioDuro’s drug screening, DMPK, integrated biology, and a turnkey 18,000-sq-ft vivarium, as well as Good Laboratory Practices (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.

The strategic merger of BioDuro with Formex provides end-to-end solutions for integrated drug discovery and development, API synthesis and optimization, formulation and cGMP manufacture of drug products. The companies have completed 25 IND and NDA filings with 10 to 200-fold solubility enhancement on insoluble compounds performed. Using advanced and proprietary technologies, the newly merged company offers services to enhance the 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 offer clients Phase I-III clinical development as well as clinical and commercial manufacture of drug product, with purpose-built cGMP manufacturing in San Diego. www.bioduro.com.