Malvern’s rapidly growing analytical toolkit for all stages of the pharmaceutical and biopharmaceutical product lifecycle will be on show at this year’s AAPS Annual Meeting and Exposition, in San Diego, USA (San Diego Convention Center, 2 - 6 November 2014). The company’s characterization solutions for both small and large molecule applications have expanded over the past 18 months, both through the acquisition of new technologies and the launch of novel accessories for its established product ranges. The portfolio now encompasses a number of complementary characterization technologies designed to accelerate development and manufacture, and support the application of Quality by Design (QbD).
In October 2014, Malvern introduced two new accessories for the market-leading Mastersizer range of particle size analyzers. These include the innovative Hydro Sight imaging accessory, designed to enable rapid method development through providing real-time visual monitoring of liquid sample dispersions. This helps save time and resource, so that methods can be validated quickly and transferred from analytical R&D into routine use. Alongside this, the new Hydro SV small volume liquid sample dispersion unit supports reliable particle size analysis using just a few milliliters of dispersant. This is especially important during early stage development where sample may be scarce. Both of these new accessories are designed to support the needs of the pharmaceutical industry, providing access to reliable particle size data at all stages in the product development lifecycle.
The recent acquisition of MicroCal has added market leading microcalorimeters to Malvern’s offering, extending the company’s technology portfolio into drug discovery. Malvern 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.
To support the development of biologics, Malvern this year introduced the Zetasizer Helix, which combines dynamic light scattering with Raman spectroscopy. Its primary application is in determining the secondary and tertiary structure of protein-based biotherapeutics to gain a better understanding of protein conformation as part of early-stage screening. Alongside this, Malvern’s acquisition of NanoSight and the purchase of the Archimedes system from Affinity Biosensors have expanded its analytical technologies for determining formulation stability and detecting aggregates within biologic formulations.
The Archimedes system employs the technology of Resonant Mass Measurement (RMM) and also offers the ability to distinguish between particles of proteinaceous or foreign origin in the sub visible size region. It has important applications in biopharmaceutical safety assessments, such as identifying and quantifying silicone oil contaminants in pre-filled syringes.
For more information on Malvern’s solutions for pharmaceutical and biopharmaceutical analysis, visit www.malvern.com/industry-applications
For more information about AAPS, visit http://2014aapsam.zerista.com/
Malvern, Malvern Instruments and Mastersizer 3000 are registered trademarks of Malvern Instruments Ltd.