Cambridge, UK 21 March 2019 – Abzena, the leading biologics target to GMP partner research organisation (PRO), announced its Cambridge UK site has brought together its extensive discovery, immunogenicity assessment, protein engineering, formulation, bioassay and analytical expertise to launch a developability assessment and optimization service to assist customers in selecting and developing the best lead candidate to take forward for manufacture.
The new Developability Service reduces the time, risk and cost required to take multiple lead candidates through cell line development and manufacturing. Biologics have potential liabilities for safety, functionality, stability and scalability and when these issues are identified early alternate leads can be selected, liabilities engineered out or measures can be taken to mitigate risk. The Developability Service also enables the selection of drug candidates most aligned with the target product profile by evaluating a range of functionality and specificity readouts.
The service is adapted to the stage of development and the properties of the molecule and provided on a dedicated FTE basis, ensuring flexibility and depth of exposure to the lead candidates. Customers can then seamlessly transition the program into cell line development using Abzena’s proprietary cell line.
Dr Campbell Bunce, Abzena’s SVP of Scientific Operations and Cambridge UK site head commented: “Abzena is excited to combine solutions where we have deep expertise and resource into a single low-cost Developability Service. Our customers rely on our ability to significantly shorten timelines, derisk lead optimization and improve clinical outcomes. Our Developability Service is provided on an FTE basis and typically requires only a few months per project to evaluate several drug candidates. We are delighted to add this service to our existing integrated discovery, cell line development, process development and biologics GMP manufacturing capabilities.”
Dr Jonathan Goldman MD, Abzena CEO added: “Abzena is the only PRO dedicated to target to GMP for large molecules, ADCs and complex small molecules. We are delighted to announce this expansion of our integrated capabilities. Our goal is to assist customers in translating complex scientific concepts to safe and effective clinical products and rapidly bring these to patients in need.”
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Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and ADC drug development services in the pharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com.
Abzena’s Developability assessment runs parallel to the drug development pathway with high-throughput in silico analysis of drug candidates following antibody discovery, moving to comprehensive physical property, formulation, in vitro and in vivo assessments allowing shortlisting of candidates for cell line development and manufacture.