PT  - JOURNAL ARTICLE
AU  - Cash, Patricia W.
AU  - Narwal, Roja
AU  - Levitskaya, Sophia V.
AU  - Krause, Stephan
AU  - Murphy, Derek
AU  - Mazaheri, Maryam
TI  - Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
AID  - 10.5731/pdajpst.2015.006064
DP  - 2016 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 134--142
VI  - 70
IP  - 2
4099  - http://journal.pda.org/content/70/2/134.short
4100  - http://journal.pda.org/content/70/2/134.full
SO  - PDA J Pharm Sci Technol2016 Mar 01; 70
AB  - Visible particles must be monitored as part of the control strategy for pharmaceutical products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In biopharmaceuticals, formation of protein particles is recognized as an inherent quality attribute. All protein therapeutics contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter) and, as part of the control strategy, biopharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein therapeutics. A new, semi-quantitative method using particle standards for assessing the levels of small, inherent visible particles is presented. This method can be used during product development to identify a formulation that minimizes particle formation and also during release and stability testing to monitor and control inherent proteinaceous visible particles.LAY ABSTRACT: Visible particles must be monitored as part of the control strategy for parenteral biopharmaceutical drug products. In these products, formation of protein particles is a natural occurrence. All protein drugs contain particles that vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter), and pharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. There is an industry-wide unmet need for particle standards for visual inspection of protein drugs. A new, semi-quantitative method using particle standards for assessing the levels of small, naturally occurring visible particles is presented. This method can be used during drug development to identify a formulation that minimizes particle formation and also during testing of final clinical or commercial drug product to monitor and control naturally occurring proteinaceous visible particles.