What Role Does QbD Play In Pharmaceutical Feasibility Studies?

By Lonnie Barish, MBA, VP of Business Development and Marketing, Bora Pharmaceuticals

We are often asked, “Why do we need Pharmaceutical Feasibility Studies?”. In the development of a new drug, it is important to note that a feasibility study is probably the single most important consideration.

This is where, as your manufacturing partner, we begin to stress and optimize the formula, the process, the equipment train, and all the upfront variables that must be evaluated and confirmed. Because development can present many challenges including issues with quality or inefficient processes, it is always necessary and in both party’s interest to jointly develop a feasibility plan where the key processing parameters and steps are tested. This is an important first phase of any product or process development work you may be considering, for a new product or an existing drug.