Validation of accuracy and precision of important assays used for dose finding and stability studies, dossiers and release protocols are of key importance for all industries in the pharmaceutical or healthcare industry. So you need a partner that can provide you with the linearity and precision on the dot. Can we be that partner? We, the creative out-of-the-box thinking NotYourOrdinaryScientists? Should we be that partner?

-Yes. Because we are a team where we’ve made an effort to cover all corners of the Myers-Briggs space and that is very often more needed than found. Here is a case when a technical validation was going to be made for an assay of a notoriously unstable compound. When the reference is not stable, you need to bring your thinking hat in to the lab and you need to mix the physical-chemist, analytical chemist with the inorganic chemist (how many teams in pharma do at all have an inorganic chemist?!).

The molecule HOCl is deceivingly simple. The method, UV spectroscopy is deceivingly simple. Well, deceiving is the word and we tricked it back in place. Through clever use of a solid reference (that melted in room temperature), black-hatted in-house characterisation of the same (do not ever take data sheets for a fact), notorious checks of all ingoing solvents and their relevant stabilities, we came up with the most linear of linearities, clear boundaries in relevant concentrations for our client and a transferable protocol for any GLP organisation that they want to partner with for their next step towards the market.

We are creative and this is not in contrast to accurate, no more than Michelangelo was sloppy on details (yes, I just compared us to Michelangelo). The technical validation we did for our client SoftOx gave an amazing accuracy and unheard of precision and it was made by people who respect and use their different competences. For the key importance of validation, the multifaceted team of CR is the key resource.

 

Picture “First day of creation” one of the panels by Michelangelo for the Sistine Chapel created between 1508 and 1512. Provided by Wikimedia Commons.