Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
I was interviewed back in April for a Pharmaceutical Technology (PharmTech) article about demand drivers for small-molecule APIs. The article by Agnes Shanley – Pharma APIs: It’s Still a Small…
I’ve mentioned the importance of route scouting in the past. Now I’d like to share some of the properties of API synthesis that can affect the yield, purity, and delivery date…
In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…
It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management. The consensus seems to be that the FDA shifted the responsibility…
Earlier this month, I wrote a post about the growth of interest in peptide therapeutics. I wanted to expand on that a bit and share three common Fmoc strategies we…
Since pioneers such as Bodanszky and Du Vigneaud first produced them synthetically in the 1950’s, peptides have always held tremendous – but unrealized – promise for human health. Despite their…
Genotoxic impurities were around long before humans first began boiling bark. Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…
We announced in late January that Neuland will be receiving a CMO Leadership Award for the third consecutive year – this time in the Quality category. This follows another recent…
