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United States Pharmacopeia (USP) held a two-day workshop, Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.
A range of topics were covered:
Day-1
Day-2
Key take-aways were noted:
The issue of particles is challenging; clearly needed is a cross-industry approach, comprising industry, academia, regulators, and suppliers, to consider life-cycle management and improve clarity. West remains at the forefront of particle technology – active in organizations addressing them, and developing new methods to measure them – always with the focus of patient safety. To read more on particle technology visit West's Knowledge Center on our website.
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, & Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.
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