Peptides are a complex drug class, and have historically proven challenging from a manufacturing standpoint. They are, however, experiencing a renaissance due to improvements in peptide synthesis, the development of…

Earlier this month we wrote a piece on the Five Challenges Scaling Up an Active Pharmaceutical Ingredient (API). In the post’s conclusion, we discussed the role of QbD in aiding…

The changes we’ve witnessed in the fields of science and medicine over the last decade or two have been truly astonishing. When we stood at the beginning of the ‘omics…

Several posts ago, I discussed an article on the ‘shifting sands’ of contract provider/pharma relationships, and how smart providers were responding to pharma’s needs, rather than establishing fixed models of…

A recent market report on APIs by Future Market Insights (FMI) paints a generally rosy economic picture of the industry over the next decade, but in this case the report’s…

In today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool. In fact, the phrase, “essential instead of optional” reminds me of the…

Deuterated compounds – in which a drug molecule’s carbon-hydrogen bond is replaced with a carbon deuterium bond to extend the drug’s half-life – continue to show promise in potentially boosting the…

Chemical synthesis of very long peptides and certain sequences considered difficult is always a challenge. In this post, we’ll share a few practical tips for improving various critical aspects of…

Continuous drug manufacturing is reported to have begun with Novartis and MIT a decade ago, but no one would dare argue that it’s taken off like a rocket ship in…

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…