We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
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.
Measurement of particles requires the use of multiple methods – depending upon the size and type of particles examined. Nanoparticle tracking, microfluidic resistive pulse sensing, and resonance mass measurement can detect particles as small as 30-50 nm. Particles from 0.3-10 μm can be detected by oil-based flow microscopy, total holographic characterization, and quantitative laser diffraction. Particles larger than 10 μm can be detected with light obscuration and dynamic fluid imaging. Dynamic flow imaging, holographic characterization and resonance mass measurement can distinguish not only size, but type (e.g., protein aggregates, silicone oil droplets).
West employs all these methods, for development as well as for addressing customer issues. A strategy for mitigating particles is proper selection of container and delivery systems. Knowing component characteristics, and understanding interactions with drug products, helps that selection. For example, work at West has demonstrated that for several therapeutic proteins, a container system comprising Daikyo Crystal Zenith® cyclic olefin polymer vials and FluroTec® laminated stoppers results in a far lower level of particle formation under stress, than a comparable glass system.
For more on how West can assist in addressing particle issues, visit our analytical services - particle analysis section of the website or contact an Account Manager or Technical Customer Service (TCS) representative.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTec® technology is licensed from Daikyo Seiko, Ltd.
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
To promote patient safety and the stability and efficacy of protein-based drugs, including mAbs, it is important to store the drugs in compatible container and delivery systems. From the time of storage until the drug reaches the patient, the protein interacts with the surfaces of these systems, which can impact the drug’s stability. The drug also can be affected by the various mechanical stresses and elevated temperatures to which it may be exposed during shipping, handling, and delivery.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
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 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>.
English
Chinese
