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#Product Trends

New tools for biopharma development take center stage on the Malvern AAPS 2015 booth

01 October 2015: Malvern, UK: New tools from Malvern that answer to specific analytical challenges in biopharma development will take center stage at this year’s AAPS Annual Meeting and Exposition, in Orlando, USA (Orange County Convention Center, 25 - 29 October 2015). 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, NanoSight instrumentation and Archimedes.

Details

  • Malvern WR14 1XZ, UK
  • Malvern Instruments

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