To encourage the use of Nanomaterials in medical products, the FDA published guidance for the industry on “Drug Products, Including Biological Products, that Contain Nanomaterials.”
Given their size-dependent properties, the new guidance seeks to address the unique risks and challenges associated with these novel materials.
Andrei Ponta, Ph.D., Review Chemist at CDER’s Division of Product Quality Assessment, shared his insights in a recent FDA podcast to clarify the Agency’s approach to regulating drug products that contain nanomaterials. This article is based on the FDA podcast.
What are Nanomaterials?
According to Dr. Ponta, “Nanomaterials fall under the umbrella of “nanotechnology” which basically means a material that has one or more external dimension, or an internal or surface structure, within the nanoscale range. A nanometer is one billionth of a meter, and the nanoscale range is approximately 1 nanometer to 100 nanometers.”
Nanomaterials are engineered to have one or more dimensions within the nanoscale range. While the general nanoscale range is up to 100 nm; the FDA has not determined a regulatory definition of nanomaterials and, as such, may consider products with one or more dimensions in the range of 1000 nm as nanomaterials.
According to FDA’s guidance, Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document) serve various functions as active or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination.”
Overview of the Guidance
The Agency’s guidance addresses nanomaterials’ potential risks in drug products, focusing on their characterization, control, testing, and qualification.
These products must meet the same safety, efficacy, and quality standards as other drugs. This guidance will help the FDA and companies address concerns and unknowns that may arise when using this new technology.
Scope of the Guidance
This guidance applies to drug products that contain nanomaterials, including cancer treatments and anemia drugs. However, the nanomaterial regulatory standards do not apply to products with naturally occurring nanoscale dimensions or those with incidental nanoscale particles from standard manufacturing processes.
Characterizing Nanomaterials
Due to their minuscule size, the characterization of nanomaterials poses a significant challenge. The nanoscale dimension of these materials prevents the usage of standard microscopes for characterization and requires specialized techniques. Proper characterization of these materials is imperative, as particle size distribution can affect the product’s properties. Size distribution is directly tied to drug efficacy, product quality, and safety, and as such, the materials must be adequately characterized to minimize patient risk.
Nanomaterials as Excipients
The new guidance also recognizes the role that nanomaterials may serve as excipients in active ingredients and drugs. As excipients, these materials can play critical roles in supporting and ensuring the desired effects of the active ingredients and supporting the drug’s structure or function.
Manufacturing of Products Containing Nanomaterials
As nanomaterials can be sensitive to manufacturing conditions and scaling up, it is crucial to identify critical quality attributes (CQAs) early. Doing so can allow manufacturers to establish effective in-process controls to ensure the nanomaterials provide the proper CQAs. Additionally, drug products containing nanomaterials must meet stability and testing requirements during premarket evaluations to prevent common issues like size, morphology, or aggregation changes.
How are Drugs Containing Nanomaterials regulated?
FDA regulates all drugs, regardless of the size of their ingredients, in the same way. “We have exactly the same expectations for safety, efficacy, and quality across the board. We expect manufacturers to follow current good manufacturing practice requirements and to provide adequate characterization and testing for the FDA to make an informed decision on any regulated product marketed in the U.S.,” concluded Dr. Ponta.
In Brief
The use of nanomaterials in drug products and pharmaceuticals has innumerable implications for the pharmaceutical industry. While these novel materials provide countless opportunities for new technologies and medicines, implementing new technology can also introduce uncertainty and risk. The FDA has shown its commitment to enhancing the industry’s understanding of nanomaterials and using their unique properties to save lives.
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