Developing Solutions for Rare Diseases
Science devoted to curing the most challenging unmet needs
Scientists in Evotec’s Chemical Development Division have been working on developing scalable processes for small molecule manufacture for over 25 years. During this time, the teams have supported partners by supplying more than 250 different API’s for use in clinical trials. Some of our partners have been successful in taking their products all the way to market and Evotec continues to supply these small molecule API’s. Others have had block busting success and, under the appropriate technocommercial factors, Evotec has assisted in the technical transfer to large scale, dedicated commercial manufacturing plants.
Developing small molecule treatments for rare diseases presents some unique challenges. Fast track designations means that CMC timelines are short, analytical methods must be quickly made fit for purpose and raw materials must be made accessible through qualified supply chains, with optimised cost of goods and timelines. Evotec’s drug development strategies are focussed on integrated services that combine to rapidly create safe and robust processes that can be scaled-up in optimum timeframes to supply critical materials into drug development from pre-clinical studies and small volume market supplies. At Evotec’s Europe-based development facilities, scientific functions in synthetic chemistry, analytical chemistry and manufacturing operations are co-located, creating an ideal environment for integrated problem solving that is required to quickly transition an asset from the discovery phase into clinical development and beyond. Evotec’s integrated drug discovery centres are located at Campus Curie in Toulouse, France, and Campus Dorothy Crowfoot Hodgkin in Abingdon, UK. Evotec’s site in Verona, Italy, is a premier site for small molecule integrated drug development with over 40 years’ experience of drug development. The Verona site covers the whole drug development continuum and has capability to produce commercial drug product at volumes compatible with Rare Disease demand.
Following the acquisition of Just Biotherapeutics (now Just-Evotec Biologics) in 2019, Evotec can offer under one roof the discovery, development, clinical, and commercial manufacture of biological based therapeutics. With the anticipated launch of the J.HALsm, AI-based monoclonal antibody (mAb) discovery platform, Just-Evotec will offer full-humanized antibodies devoid of significant manufacturing liabilities thereby reducing the discovery and development timeline by several months. With regard to cell-line development, clinical and commercial manufacturing of biologics, Just-Evotec’s platform is specifically well suited for the rare-disease space as it was designed from its inception to provide the highest manufacturing yields while reducing COGS using its perfusion-based continuous-manufacturing platform. For rare-disease indications this approach is especially attractive: high yields reduce the need for multiple manufacturing campaigns thereby keeping overall development cost lower.
Combining this benefit with Evotec newly acquired preclinical development capabilities (IND-enabling studies) and first-in-human (FIH) clinical study support streamlines the timeline to the clinic also saving precious time and development costs. Importantly, the Just-Evotec team have over 250 combined years of experience in the development and manufacturing novel biologics, biosimilars, and next-generation processes.