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Particulates in injectable drug products continue to be an area of great interest in the industry. The main reason is the potential clinical effects on patients, which can range from emboli to inflammations to infections. There are a series of clinical risk factors that should be considered in evaluating and mitigating these challenges. These factors are route of administration, patient population, and particulate composition (i.e., number, size, and shape). All are critical inputs to understanding risk and determining corrective and preventative actions.
The greatest area of concern is extrinsic particulates, as these are considered foreign to the drug product. The presence of these particulates resulted in 212 recalls of injectable drug products from 2009 through early 2019 [Sheena Hailin Wang, Ph.D. (FDA/CDER/OPQ Office of New Drug Product II), Regulatory Perspective on Inspection of Injectable Products for Visible Particulates. 2019 PDA Visual Inspection Forum, Washington, DC (4/23/19). See also U.S. FDA Rep Offers Overview on Visible Particulates located at https://www.pda.org/pda-letter-portal/home]. A review of the timeline shows that recalls peaked in 2014, but since have declined. This is an improvement, but clearly there is room for further improvement.
In order to achieve further improvement, it is critical to understand testing approaches and all factors that could impact particulate formation and drug product contamination. At West, particulates are a thrust area. We have the expertise and facility not only to measure particulate levels and types precisely, but we are also actively engaged in developing new measurement methods.
For more on how West can help, contact an Account Manager or Technical Customer Support (TCS) representative.
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.
As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.
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