The new biology discovery unit features significant translational oncology and immuno-oncology capabilities centered around high fidelity patient-derived tumor models, such as in vitro 3D human tumor microenvironment (hTME-3DX Screen and Verify™), or in vivo patient-derived xenograft (PDX). The site features advanced immuno-oncology capability with development of patient-matched tumor/immune cell models, originating from the world's largest bank of tumor, immune and stromal cells—more than 100,000 viable specimens. Additionally, the San Diego discovery center offers researchers a regional site for oncology studies requiring local capability. These new capabilities complement the large existing oncology footprint in Shanghai, including in vitro screening, in vivo cell line-derived xenograft (CDX), syngeneic and PDX.
"The addition of the translational oncology site in San Diego allows our oncology clients to study their drugs in real patient-based tumor and immune cell models," said Thomas B. Broudy, EVP Translational Sciences. "These models more accurately represent the clinical population, and that helps our drug development partners to build confident clinical strategies—from cancer type to patient selection to combination approaches."
CMC operations under the same facility provide drug product development, analytical testing and GMP manufacturing for clinical trial materials, further accelerating timelines and maximizing success by ensuring that candidates entering the clinic have the optimal profile.
To facilitate efficient transition from Discovery to Drug Product Development, BioDuro's Global CMC team has adapted techniques used in later stage development to solve problems encountered in candidate selection. For example, using amorphous processing techniques, non-toxic preclinical formulations for increasingly encountered insoluble drugs can be generated that rely less on organic solvents or surfactants, giving cleaner results in efficacy or toxicology studies. These approaches, coupled with BioDuro's powerful screening techniques allow significant formulations design decisions to be made utilizing only milligrams of API at a stage of development when API supplies are very limited. Furthermore, these formulations approaches can be scaled from milligram to kilogram scale under GMP, significantly shortening development times and de-risking many aspects of the development process.
"San Diego is regarded as one of the largest biotech hubs worldwide, and its geographical location makes it readily accessible to our domestic and international partners", said Cyrus K. Mirsaidi, President and CEO. "Expansion of our San Diego facilities, and growth of our Drug Discovery capabilities, reflects our commitment to providing continuous and innovative service offerings to reduce the time and cost of new drug development."
BioDuro is a leading, global life sciences research and development organization that provides biopharmaceutical clients and partners with comprehensive, fully integrated drug discovery services spanning target identification to IND filing, through to GMP manufacture of drug substance for clinical trials. With depth and breadth of therapeutic expertise in small and large molecule discovery, development and scale up, combined with unique technology platforms such as high content 3D drug screening, in-vivo translational models, and bioavailability enhancement of insoluble compounds, BioDuro is well positioned to help biopharmaceutical partners significantly accelerate their lead discovery programs, and de-risk development programs for higher value outcomes. Visit www.bioduro.com
BioDuro is a portfolio company of the Bridgewest Group, a closely held investment company with significant assets under management in hi-tech and wireless technology, biotech and pharmaceuticals, real estate, banking and capital markets.
SOURCE: BioDuro LLC.