A Faster And More Economical Path To Investigational New Drug Applications

By William C. Barrett, Ph.D. and Doug Puzia, Gore PharmBIO Products

It is a long, expensive, risky, and time-consuming process to get a drug ready for an investigational new drug (IND) application. With many companies developing competing molecules for the same indications, the potential to make billions can come down to who gets their drug through FDA clearance first. A few weeks can make a big difference in the sales needed to recoup the investment.

With all that is at stake, biopharma companies are looking for smarter and more flexible paths to IND. They not only want to reach this stage faster but also need to get more molecules ready for an IND application to increase their chances of success. With a smaller footprint and faster cycle times, new membrane-based protein A affinity chromatography technology can greatly shorten the time it takes to get to IND while also making the process less expensive and more adaptable.