RT Journal Article
SR Electronic
T1 Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2015.006064
DO 10.5731/pdajpst.2015.006064
A1 Cash, Patricia
A1 Narwal, Roja
A1 Levitskaya, Sophia
A1 Krause, Stephan
A1 Murphy, Derek
A1 Mazaheri, Maryam
YR 2016
UL http://journal.pda.org/content/early/2016/01/14/pdajpst.2015.006064.abstract
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 of 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.