BioDuro has established a new drug discovery center for chemistry and biology in San Diego, CA. The goal of the discovery unit is to help drug developers advance into the clinic with confidence.
The new biology discovery unit features 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 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.
"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."