With the kick-off meeting on July 14th, 2015, in Barcelona, a consortium of eight different partners with complementing background and expertises in the pharmaceutical industry joint together to initiate the set up of a novel scientific and commercial platform on drug impurities and degradation products.
Aim of this unique “INNOVATIVE IMPURITY INITIATIVE” project is to collect, explore, furnish and evaluate data on pharmaceutical impurities using an innovative and multi-disciplinary approach to maximize scientific outcome and commercial benefit for each partner and provide information for the pharmaceutical community.
In general, the availability and quality of data and information on drug impurities and degradation products is very poor, and it is a tedious job to deal with this issue. Hence, a main focus of the joint project lies on collecting, processing and organising data and information and to provide it to science, industry and regulatory authorities. It will be the first step for establishing a database on impurities and degradation products which could be used by many people with different educational background. This database should contain data on chemistry, physical behaviour, stability, physico-chemical properties, biological, pharmcological and toxicological effects, data on environmental behaviour etc. useful for chemists, pharmacologists, pharmacists, toxicologists from academia and industry but also for people from regulatory authorities. This information will be enriched and complemented by further data, which mainly have to be determined in silico or by additional experiments like anti-target effects, target binding profiles, ADMET properties etc.
It is also intended to have the compounds available in physical form (coming from synthesis or isolation) to set up an impurity and degradation product library for further use or processing.
First activities started in July 2015 with the exporation of the first drug class and the data first package including in silico and experimental data as well as novel impurities, etc. will be available by Q1 2016!
For any information please contact RD&C!
