Applications Nanoparticle analysis of protein aggregation
Spectradyne’s microfluidic technology enables detection of any nanoparticle type!
The Spectradyne nCS1TM employs a novel implementation of the resistive pulse sensing method (MRPS) to count and size nanoparticles quickly and with high resolution. Sizing precision of ±3% is typically achieved, with measurement rates up to 10,000 particles/s.
“Submicron protein particle characterization by Resistive Pulse Sensing results in high size resolution and provides an estimate of particle counts, thereby, provides better insight into particle size distribution compared to the traditional light scattering techniques.” G.V. Barnett, J.M. Perhacs, T.K. Das and S.R. Kar, Submicron Protein Particle Characterization using Resistive Pulse Sensing and Conventional Light Scattering Based Approaches in Pharm Res. 35, 58 (2018) doi: 10.1007/s11095-017-2306-0 A publication from Bristol-Myers Squibb
Protein aggregation
Spectradyne’s nCS1 delivers two significant advantages for detecting aggregates in protein solutions: First, individual particle measurements (no ensemble-averaging) deliver accurate size distributions in highly polydisperse samples such as these. Second, the non-optical electrical detectionmethod ensures that protein aggregates, which are low-index contrast materials, are accurately represented in the distribution.
Particulates in parenteral drug development and production have always been a serious issue. In biologics, the issue is compounded by reported impacts of aggregates and particles on the product’s efficacy, safety and immunogenicity. FDA regulations strongly recommend in-depth characterization of the identity and quantity of particles in protein therapeutics.
While regulations require measurement of larger particles (>1 μm), it is desirable to detect and characterize protein aggregates long before they are that large. Crucial decisions about formulation, processing, storage conditions, etc. must be made with an eye towards minimizing protein aggregation throughout the drug life-cycle.
Spectradyne’s nCS2TM
Spectradyne’s nCS2 is ideally suited for accurate quantification of submicron protein aggregates. The figure below demonstrates the power of the nCS2 to quantify protein aggregation in real world samples. Five formulations that had been stressed to varying degrees (0, 10, 20, 30, and 60 minutes) were provided by a large biopharmaceutical customer and analyzed “as received” on the nCS2 – no dilution or additives were required. The range of concentrations measured by the nCS1 spanned over four orders of magnitude in this instance. The quantitative results clearly show that increased stress causes more aggregates in this formulation.
Spectradyne’s ARCTM
Spectradyne’s ARC combines the MRPS functionality of the nCS2 with a fluorescence detection capability, allowing the fast and rapid detection of fluorescent tags combined with the accurate sizing and concentration measurements provided by microfluidic resistive pulse sensing (MRPS). This adds an extra dimension to your nanoparticle and protein aggregate detection capability.
Spectradyne’s nCS2 enables earlier detection of smaller aggregates
