Advancing Innovation in Pharmaceutical and Biologics Manufacturing

FDA Voice: FDA Budget Matters: Investing in Advanced Domestic ManufacturingIn a U.S. Food and Drug Administration’s FDA Voice blog post, FDA Budget Matters: Investing in Advanced Domestic Manufacturing, FDA Commissioner Dr. Scott Gottlieb opened noting:

Advanced manufacturing, which includes various technologies, such as continuous manufacturing and 3D printing, holds great promise for improving the American market for drugs and biologicals.

Emerson's Ron Rossbach


Emerson’s Ron Rossbach shared his thoughts with me on this post. He noted that both pharmaceutical & biologic manufacturers and the FDA share a common goal of having a greater patient-centric focus with great accessibility to medicines and therapies.

What has held back some of the innovations needed to achieve this goal is the inability to engage in early discussions of novel technologies with regulatory agencies like FDA, absent formal submissions.

Dr. Gottlieb signals the willingness of regulators to take a much more collaborative approach between manufacturers and regulators:

The bottom line is this: Drug makers won’t switch to these systems [continuous manufacturing and 3D printing] until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals. The FDA recognizes that it’ll require additional investment in policies and programs that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.

Switching from batch to continuous manufacturing is a huge change from the tried and true. One of the last steps on the path to market for a new drug or therapy is approval of the manufacturing process. Ron observed that this collaborative approach can reduce the fears of possible delays in the approval process.

Dr. Gottlieb highlights the benefits of continuous manufacturing processes. They are:

…more ideally suited to new trends in drug development, such as personalized medicine and regenerative medicine products. Drugs that target small patient populations will require much greater manufacturing flexibility. The small scale of continuous manufacturing equipment works well for these endeavors. Close and continuous manufacturing systems can provide cost-effective drug product for early stage clinical development and yet can easily ramp up production for commercialization.

Ron pointed to the FDA’s Center for Drug Evaluation and Research (CDER) as an area where this collaboration has been occurring with tablets and other formed medicines. Dr. Gottlieb’s thoughts expressed in this post signals an extension of this collaborative spirit to Center for Biologics Evaluation and Research (CBER) for the biologics-based medicines.

For manufacturers the benefits of continuous manufacturing are clear:

Continuous manufacturing technologies could save 30 percent in manufacturing costs. This estimate does not include the savings from potential future technologies. That totals $60 billion per year in savings in the United States. This can help reduce drug costs.

Read the blog post for more on fostering these innovations through a more collaborative approach between manufacturers and regulators.

Ron noted that the Emerson Life Sciences industry consultants and project teams are working with several major manufacturers implementing continuous manufacturing for a more modular and flexible approach across the drug development lifecycle. Learn more about the technologies and expertise that can help drive these innovations in the Life Sciences & Medical section on Emerson.com.

You can also connect and interact with the Life Sciences industry consultants at the October 1-5 Emerson Exchange conference in San Antonio and/or in the Life Sciences group in the Emerson Exchange 365 community.