Analysis and quantitation of subvisible particles is critical to ensuring product quality and demonstrating that internal and industry standards are met.  Current analytical methods that measure subvisible particles are manual operations and therefore very labor intensive.  Based on a multi-year, cross-functional program within Amgen, an automated light obscuration sampling (HIAC) instrument for high throughput subvisible particle analysis has been achieved.  This new automated technology couples the manual Beckman Coulter HIAC 9703+ detector with Amgen-developed hardware and software, which is a first of its kind in the pharmaceutical industry.  The automated system provides flexible sampling options, a user-friendly software interface for designing protocols, sample mixing standardization, increased throughput and significant time savings.  Side-by-side testing of the manual and automated HIAC methods for a panel of Amgen molecules showed good comparability in measured particle concentrations and sizes.<br/>While this technology was initially developed for formulation development, it has broader applications across functions, especially in the manufacturing setting with Quality Control.  The design and building of a second generation automated HIAC is in progress to improve safety, further increase sample processing speeds, reduce the unit cost, and minimize the footprint.

Development and implementation of an automated HIAC approach for high throughput subvisible particle analysis

253rd National Meeting (2017)

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