Consortium formed to improve QbD software
The consortium will allow Blue Reference to cooperate with pharmaceutical companies to discover ways that its QbD software can be improved.
Unnamed pharmaceutical development and manufacturing companies are contributing their knowledge of regulatory workflow requirements, which Blue Reference believes will improve its software in line with the US Food and Drug Administration’s (FDA) QbD initiative.
Paul van Eikeren, President, and CEO of Blue Reference, said: "According to findings of the largest empirical study ever performed on the interplay of pharmaceutical manufacturing and the FDA, by postponing implementation of QbD practices the pharmaceutical industry is, in effect, wasting more than $50bn a year in manufacturing costs."
"Through collaboration with several global pharmaceutical companies, Blue Reference is creating an umbrella software solution for QbD that enables companies to substantially improve drug development productivity and timelines while reducing drug manufacturing costs and risks."
Knowledge gained through the consortium will feed into Blue Reference’s software packages, which cover QbD in development, preclinical pharmacology and manufacturing.
The software uses raw data and evaluates process interdependencies and their impact on quality to give users an understanding of areas of the system that can be improved.
