A Comparison of Background Membrane Imaging versus Flow Technologies for Subvisible Particle Analysis of Biologics

Publication date: Available online 27 January 2020Source: International Journal of PharmaceuticsAuthor(s): Stephanie K. Vargas, Aydin Eskafi, Eric Carter, Natalie CiaccioAbstractA recently developed high-throughput background membrane imaging (BMI) technique, the HORIZON, was assessed for its ability to quantify subvisible particles (SVP) generated during protein therapeutic development. The HORIZON platform method was optimized and compared to three well-characterized SVP counting techniques: light obscuration, micro-flow imaging (MFI), and FlowCam®. A head-to-head comparison was performed for precision, linearity, SVP concentration, and morphological output of BMI compared to the other three techniques using two unique enzymes under investigation. We found that dilution requirements for BMI are protein-specific, and membrane coverage is the critical instrument parameter to monitor for dilution suitability. The precision of BMI ranked similarly to all other techniques. Analysis of the same sample dilution, run in triplicate, across all four techniques indicated the BMI provides SVP concentrations that are comparable with the flow imaging techniques. Morphological information from the BMI was generally less practical when compared with flow microscopy. The major drawback of the BMI was that the current software indiscriminately clips large particles, potentially resulting in a misrepresentation of SVP size distribution. Despite this phenomenon, the concentration and size dat...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research