BioDuro, a leading global life sciences contract research and development organization announced that it has established a new drug discovery center for chemistry and biology in San Diego (USA).
The goal of the discovery unit is to help drug developers advance into the clinic with confidence, by allowing researchers to learn more about the chemistry and biology of their drugs earlier than ever before.
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.
Chemistry, manufacturing, and control (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.
BioDuro (San Diego, USA) is a leading, global life sciences research and development organization that provides biopharmaceutical clients and partners with fully integrated drug discovery services spanning target identification to IND filing, through to GMP manufacture of drug substance for clinical trials.