In late September, the U.S. FDA issued a final guidance for industry, “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization,” in an effort to improve reliability and safety and help lower the cost of pharmaceutical manufacturing.
"We’re at an inflection point in the practice of medicine, not only in terms of novel therapies, but also when it comes to the advanced technology being used to manufacture these products. In recent years, we’ve seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D-printed drug. These advancements have led to improved products for patients and consumers and the opportunity to have a more stable and lower cost supply chain,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to continuing to foster advances in innovative pharmaceutical manufacturing, which ultimately has the potential to improve drug quality and safety.”
The agency’s press release on the subject reported that incorporating promising emerging and novel technologies into the drug manufacturing process is critically important for maximizing quality and minimizing manufacturing issues. Modernizing manufacturing technology can lead to a better product design and a more robust manufacturing process with fewer interruptions in production, fewer product failures, and greater assurance that the drug products will provide their expected clinical performance.
Theguidance provides recommendations to companies that are interested in participating in the FDA’s Emerging Technology Program (ETP). The ETP program promotes the adoption of innovative approaches to pharmaceutical manufacturing and product design. It also provides a route for companies to engage with the FDA early, prior to regulatory submission, to submit questions and proposals regarding the use of specific emerging technologies. The scope of the program focuses on innovative and novel technologies that have the potential to improve drug product safety, identity, strength, quality and purity. The FDA has found that early engagement enables the identification and resolution of potential challenges concerning the implementation of emerging technologies.
The ETP features an Emerging Technology Team (ETT) that includes representation from all FDA pharmaceutical quality functions. ETT considers emerging technologies for small molecules, for larger biological molecules and for multiple products, including:
• Closed aseptic filling system
• Isolator and robotic arm for aseptic filling
• Novel container and closure systems for injectable products
FDA says, “Applications to the ETT are appropriate if (a) the proposed technology has the potential to improve product safety, identity, strength, quality and purity, and (b) the new technology includes one or more elements subject to quality assessment for which the Agency has limited review or inspection experience. Examples of such elements include an innovative or novel:
- Product technology (e.g., dosage form or packaging such as a container and closure system);
- Manufacturing process (e.g., design, scale-up or lifecycle approaches); and/or
- Control strategy (e.g., testing technology or process controls).