Case Study

Managing Risks In The Development And Manufacture Of Potent Pharmaceuticals Products

Source: Pharmaceutics International
Clean Room

Due to perceived and real risks, certain classes of pharmaceutical products have historically been manufactured in dedicated or segregated, self-contained facilities, in order to mitigate cross-contamination concerns.  Recent market reports suggest there’s an increasing number of niche and orphan drugs in development, rendering dedicated production facilities less practical.  Given the variety of products currently in development, including potent drugs, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, has proven to be an effective strategy.