The selection of the appropriate primary packaging for an injectable drug product is one of the most crucial considerations in the drug development process – the wrong choice can cost significant time and resources. The increasing number of complex and sensitive biologics is only adding to the pressure to get it right first time.
A particular challenge when it comes to biologics is the issue of sensitivity. It has always been a problem for the pharmaceutical industry, but it is even more of an issue now that more drugs are biologics and highly concentrated. By some estimates, 20-30% of drug formulations now have sensitivity issues – reacting to one or more elements of their primary packaging and losing their stability.