In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…
While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…
A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…
It’s a common misconception that process chemistry refers strictly to process scale-up. While it’s true that process chemistry is a crucial component of optimizing the scale up of an active…
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…
Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…
Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…