The identification and analysis of particles is a key task involved in the development and manufacture of such diverse products as vaccines and virus-like particles (VLPs), exosomes, and biological drugs, to ensure that they are well-characterized, safe and effective.
Malvern Panalytical provides an analytical toolset that delivers unique and supporting data for the quantification, identification and characterization of bioparticles, ranging in size from those that are visible, through the subvisible range, down to submicron-sized particulates.
Our bioparticle characterization solutions are truly orthogonal and produce high resolution data sets informing on particle populations in biologically-relevant samples – including complex solution conditions - providing insight and information which has previously been inaccessible to researchers.
Extended submicron/subvisible particle characterization
Control of subvisible particle populations in biotherapeutics is a regulatory requirement, as their presence can impact efficacy and increase immunogenic risk. Quantifying the submicron particle population (0.1 - 1 mm) provides a more complete aggregation profile of bioformulations, and this size range is attracting more regulatory attention.
- Extended characterization methods provide information on subvisible particle populations down into the nanoparticle-scale range – including differentiation between proteinaceous and non-proteinaceous particles
Contaminant particle identification
The presence of particulate matter is one of top ten reasons for recall of parenteral products, and is subject to regulatory requirements. Robust procedures are essential for identifying and analyzing inherent, intrinsic and extrinsic particulates in drug products, and as a critical part of process control for manufacture.
- Combining automated particle imaging of proteinaceous and non-proteinaceous particles with direct chemical identification provides diagnostic capabilities and traceable data for process and product control
Research activities into understanding exosomes and wider classes of extracellular vesicles and microvesicles are burgeoning, due to their potential for diagnostic, therapeutic and drug delivery use. Characterization of these biological particles in their natural environment is of significant value in elucidating their role in disease pathways.
- Rapid and high resolution assays for exosomes and microvesicles for quantification of particle populations, and for stability and purification assessment and control
Particle profiling of viruses and vaccines
Investment into vaccine development is increasing rapidly to tackle the evolving threat of communicable diseases and address larger emerging markets. As newer and more expensive vaccines get to market faster, emphasis on the production, yield, purity and stability of vaccines and virus-like particle formulations is increasing in importance.
- Rapid methodologies for total particle profiling and aggregation state for virus and virus-like particle preparations and vaccine developments to assess biological function, stability and purification