Particles, whether visible or sub-visible, in a drug product are a very serious concern (e.g., obstruction of blood vessels, inducement of immunogenicity). Particles may result from external sources (e.g., dust), manufacturing (e.g., silicone oil), or interaction with the container/delivery systems (protein aggregates). This section presents papers on particle measurement, management and resultant effects.
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In order to better understand sub-visible particle contribution, particularly from silicone-treated stoppers, a study was designed to determine optimal methods to measure and identify SVP. This presentation will describe the sample preparation considerations for components and analytical technologies for SVP. Data sets will be compared to demonstrate the strengths and weaknesses of various methods.
This webinar examined management of particles in sterile drug products from a holistic perspective – as one of several factors that must be managed in the effort to deliver safe drug products. Covered were types of particles based upon origin, composition, and size – in particular those resulting from interactions of packaging with drug products. Also covered were experimental methods to measure and statistical methods to evaluate data.
<p><span style="color: #333333; letter-spacing: normal; background-color: #ffffff;">By Mike Haley, AbbVie; Dave Hile, Shire; Laurent Screve, GSK; Nick Dyar, Biogen; and Malcolm Gilmore, BioPhorum Operations Group</span></p>
<p>This paper explains currently used particle count methods, describes their differences, and provides suggestions for consistency and potential areas for improvement.</p>
<p>This review article considers in detail the risks caused by the presence of visible and sub-visible particles in parenteral drug products.</p>
<p><em>S. Bukofzer, et al. PDA Journal of Pharmaceutical Science and Technology, 69, 123-139 (2015)</em></p>
This article considers several aspects of particles in parenteral drug products: (a) sources, (b) composition/shape/size, (c) differing effects depending upon place/route of administration and condition treated, and (d) regulation.
<p><em>S.E. Langille. PDA Journal of Pharmaceutical Science and Technology, 67, 186-200 (2013)</em></p>
This presentation reviews methods for detecting particles of varying sizes and how those particles are viewed by regulatory agencies worldwide.
<p><em>J.G. Shabushnig (Insight Pharma Consulting, LLC) (June 2014)</em></p>