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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.
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