FDA Issues Draft Guidance on Continuous Manufacturing

By Patricia Van Arnum - DCAT Editorial Director

February 28, 2019

The US Food and Drug Administration (FDA) has issued draft guidance, Quality Considerations for Continuous Manufacturing, to specify key quality considerations and provide recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small-molecule, solid oral drug products that are produced via a continuous manufacturing process.

The draft guidance clarifies the FDA’s current thinking regarding continuous manufacturing approaches to help resolve potential issues some companies have as they consider implementation, such as concerns that use of new continuous manufacturing technology might impact the time the FDA takes to assess applications for new products and for switching from a batch to a continuous-manufacturing process for existing products.

In addition to the draft guidance, FDA Commissioner Scott Gottlieb outlined in a February 26, 2019 statement the other steps that the FDA has taken to advance continuous manufacturing. He said that the FDA also proposed development of a guidance on continuous manufacturing to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH assembly accepted the FDA’s proposal and set a goal of finalizing the guidance by 2021. “This harmonized guidance will help advance the brand and generic drug industries ability to obtain approvals for products manufactured using CM [continuous manufacturing] processes in multiple regions,” he said in the agency statement.

Gottlieb said that the agency has taken other steps to advance the adoption of these technologies, including a request for funding to help advance continuous manufacturing as part of the President Donald Trump’s 2019 budget.

He added how the agency can also address concerns that companies may have in changing over from a batch to a continuous manufacturing process, such as in the cost of new equipment. “The FDA can help address these issues by providing clear guidance on what process and control strategy designs (including equipment) are needed to meet regulatory considerations and how a CM [continuous manufacturing] platform technology can be used to manufacture multiple products, so that product developers can have more certainty about the capital investments they need to make,” said Gottlieb in the agency statement. “This can provide sponsors with more assurance about the costs of adopting these new methods and the payoffs they can anticipate from making these investments.”

He also stressed the importance of the FDA in providing regulatory clarity for companies using continuous manufacturing processes. “Since processes and facilities for CM [continuous manufacturing] differ from traditional operations, some companies have questions about how using this new technology will impact the way the FDA and other regulators assess new drug applications when the products are being produced using these methods, and how regulators will approach facility inspections,” he said in the agency statement. “It’s incumbent on the FDA to ensure that companies clearly understand our regulatory approach so they’re confident in making this investment.”

To date, Gottlieb said there are four companies manufacturing five approved products using continuous manufacturing. He added that approximately 20 additional companies, both brand and generic, have engaged the FDA in their efforts to develop and implement continuous manufacturing processes.

Source: US Food and Drug Administration