Design of Experiments (DoE), introduced in the 1920s, is a valuable modelling tool to support in amongst the systematic development of (bio)pharmaceutical products, processes and analytical methods. Especially in combination with risks assessments (e.g. FMEA), DoE is paramount of importance to establish quantitative relationships between potential critical parameters (related to e.g. product, process, method) and a defined response (e.g. product quality).
Compared to other industries, the (bio)pharmaceutical industry has been a relatively late adopter of DoE. Nowadays, DoE has become a recognized tool likely boosted by the implementation of Quality by Design (QbD), the approach to design a quality product and a well understood, controlled and high performing manufacturing process.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).
