My name is Colman Byrne, and I am the head of analytical services for DSI. I have been with the organization for nearly 17 years and have over 40 years of industry experience working with a variety of companies in the analytical area. I started as a bench chemist and then ran a contract testing lab that focused on biological and protein peptide-related types of samples.
I then joined a few small virtual pharma and biotech companies, coordinating their analytical services and bioanalytical testing and managing the activities of contract test organizations. I joined DSI when it started and, since then, have worked in many areas, from early-stage analytical method development through method validation, specification and shelf life justifications and on regulatory filings and post-filing support for Complete Response Letters, out to post-approval release testing of commercial products and analytical investigations. Analytical services are at the crux of all pharmaceutical developments activities because they are required for the active material to establish it's purity/quality from the beginning of development, and they are required to establish the efficacy and safety of the drug product at the time of release.
Testing ensures adequate stability of the product and establishes the shelf life. Purity is ensured initially by having the API and drug product well manufactured, under control and under cGMP, but appropriate, specific and adequately sensitive analytical tests verify it..
