New Tools for Biopharma Development

Alongside Malvern’s established analytical suite for both large and small molecule development will be a range of 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 two new products: the thin-path wet cell for the 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, most especially in the area of subvisible particle characterization. The Morphologi G3-ID is now a powerful tool for answering the ‘what is it?’ questions that so frequently 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 new capabilities are proving especially valuable.

The Viscosizer TD utilizes 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 valuable resource for developability screening. 

These new systems augment Malvern’s established portfolio of instrumentation for large drug molecule development which includes: the Zetasizer range for high throughput size measurement and stability assessment during early formulation; NanoSight instrumentation which is especially helpful for subvisible particle size and count; and Archimedes, which employs Resonant Mass Measurement (RMM) technology to efficiently differentiate particles of proteinaceous or foreign origin in the subvisible size region, most especially silicone oil. OMNISEC, Malvern’s flagship Size Exclusion Chromatography (SEC) system will also be on display. It delivers detailed protein characterization for the rigorous investigation of protein aggregation, from just nanograms of 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 a particle size measurement, Hydro Sight eases the 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 market leading microcalorimeters will also be available at the booth, throughout the event for those looking to exploit this highly 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.