AUC for modern Pharma and Biotech
Nanoparticles are important entities for the modern pharmaceutical industry – but often challenging to characterize and control. Viral vectors (VV), lipid nanoparticles (LNP), and exosomes are examples of vehicles for gene therapy, protective drug product formulations for modern modalities like mRNA, or advanced therapy medicinal products (ATMPs) in itself. The thorough analysis of these complex products requires specialized expertise in complex particle characterization.
Aggregates of biopharmaceuticals on the other hand are typically undesired and require tight control, as they can result in patient safety issues. While chromatographic methods interact with the sample and matrix, AUC is a neutral observer that does not stress the therapeutic protein.
Benefits and Applications of AUC
- Orthogonal analytical method, complementing routine assays (electrophoresis, spectroscopy, or chromatography), e.g. for root cause investigations, extended product characterization, or empty-to-full ratio of capsids.
- Separation and quantification of particles with identical surface properties based on size, shape, weight ,or density, e.g. quantification of protein aggregates, aggregate profiling for biosimilarity studies, exosome size distributions (extracellular vesicles).
- Quantification of identical particles, which only differ in their hidden inside cargo, and scientifically sound characterization of the cargo: e.g. empty-to-full ratio of viral capsids or liposomes and lipid nanoparticles (LNPs).
- Advanced AUC techniques, such as 4D-AUC, allow for the characterization of the particle or its hidden cargo, in the same experiment while separating and quantifying the particles.
- AUC is a neutral observer: Testing is performed in the original concentration, storage buffer ,or drug product formulation. No interaction with the sample and matrix that could stress the sample and result e.g. in artificial aggregation due to the testing conditions. No dilution of high-concentration formulations that could put low aggregate results in doubt.
Nanolytics provides specialized analytical services to the pharmaceutical industry, with more than 20 years of experience and superior, world leading detection options for analytical ultracentrifugation (4D-AUC, AIDA).
We support e.g. research, process development, root cause investigations, comparability studies for biosimilars, or extended product characterizations by AUC.
In addition to pharmaceutical applications, Nanolytics has broad expertise in AUC analysis of colloidal systems and other nanoparticulate systems (e.g. applications in material science).
Nanolytics provides quick response times. Typically, analyses are run within a few days upon sample receipt. Reports are compiled within a few more days.