Validation of a novel preclinical development platform to enable high value therapeutic co-formulations

There is an unmet need to develop advanced therapies that combine two or more therapeutic products in one dose to improve patient convenience. This leads to better compliance, improved health outcomes and a better patient experience. However, it is often impossible to develop these co-formulations due to very different formulation conditions required to stabilise individual pharmaceutical ingredients in the same aqueous environment. Highly innovative formulation platforms are therefore essential to enable many of these commercially attractive combination products. Arecor has developed and successfully commercialised a proprietary formulation technology that delivers superior stability of therapeutic proteins compared with coventional formulation optimisation. To date the technology has only been successfully applied to single pharmaceutical ingredients, and the purpose of this project is to adapt the technology to overcome additional issues associated with co-formulations. Issues such as drug-drug interactions, in-vivo bioequivalence, stabilisation under non-optimal conditions, device compatibility and toxicological safety will all be evaluated under this preclinical platform. To ensure efficiency a validated state-of-the-art robotic liquid handling and multivariate design combined with high throughput analytics will be employed. Whilst the primary objective is to adapt and validate an innovative pre-clinical platform, co-formulations with high commercial potential will be a secondary output.