New tools from Malvern that address specific analytical challenges in biopharma development will take centre stage at this year’s AAPS Annual Meeting and Exposition, in Orlando, US.
The event will take place at Orange County Convention Center from 25 – 29 October. Alongside Malvern’s analytical suite for large and small molecule development will be complementary and orthogonal characterization technologies with proven value for accelerating innovator and generic product development.
Malvern’s ongoing strategy of working closely with the biopharmaceutical industry to rapidly commercialize the analytical technology needed to advance safe and efficacious products is evident in the thin-path wet cell for Morphologi G3-ID and the Viscosizer TD.
The new thin-path wet cell enables measurement of the size, shape and chemical identity of suspended particles in their native state with no requirement for filtration.
Its introduction, alongside new flexible software tools and access to Bio-Rad’s KnowItAll 2015 software, transforms the value of Morphologi G3-ID for biopharma development, especially in the area of subvisible particle characterization.
The Morphologi G3-ID is a powerful tool for answering the ‘what is it?’ questions that arise during development, manufacturing and stability programs, when particles cannot be reliably and fully characterized using standard light obscuration and flow imaging techniques.
Identification of the nature and provenance of subvisible particles is a good example of where these capabilities are valuable. The Viscosizer TD uses the technique of Taylor dispersion analysis to deliver unique solution-based molecular sizing capabilities, combined with relative viscosity measurement.
Ultra-low sample volumes, fully automated measurement protocols and precise environmental control for sample storage and measurement make this new system highly suitable for stability and formulation studies and a resource for developability screening.These systems augment Malvern’s established portfolio of instrumentation for large drug molecule development.
The portfolio includes the Zetasizer range for high throughput size measurement and stability assessment during early formulation and NanoSight instrumentation, which is helpful for subvisible particle size and count.
It also includes Archimedes that has resonant mass measurement (RMM) technology to differentiate particles of proteinaceous or foreign origin in the subvisible size region, especially silicone oil.
OMNISEC, Malvern’s flagship Size Exclusion Chromatography (SEC) system will also be on display. It delivers detailed protein characterization for rigorous investigation of protein aggregation, from nanograms of a sample.
A key focus for small molecule development will be Hydro Sight, an innovative imaging accessory for the Mastersizer 3000.
Capable of capturing images in real-time during particle size measurement, Hydro Sight eases method development and method transfer tasks associated with the optimal and secure application of laser diffraction particle size analysis across the product life cycle, from formulation, through scale-up and into manufacture.
Expert advice on the application of Malvern’s MicroCal range of microcalorimeters will also be available at the booth throughout the event for those looking to exploit this informative technique.
MicroCal isothermal titration calorimeters and differential scanning calorimeters provide information on drug binding and protein stability, and are used at almost every stage of drug discovery, development and formulation.