By Mark Schofield, Ph.D.
The increased flexibility, efficiency, and quality that come with continuous processing are just some of the benefits driving the growth of this innovative alternative to batch manufacturing. From a regulatory perspective, the FDA has been encouraging industry efforts to move the industry to this modernized approach for the last several years. That is because the agency recognizes the advantages of continuous processing, where smaller equipment and facilities are leading to fewer steps and lower capital, operational, and environmental costs. The overall savings are then passed on to both the industry and, most importantly, the patients. However, among other regulatory questions surrounding this transition is the uncertainty around implementing an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.