Materials characterization company Malvern Instruments Ltd. (Malvern, UK) has signed an exclusive distribution agreement with Affinity Biosensors LLC (Santa Barbara, CA, USA) which will extend the range of solutions that Malvern offers to the biopharmaceutical sector. The distribution agreement covers all geographies outside the USA and Canada

Under the terms of the agreement Malvern will distribute the Archimedes Particle Metrology system, developed and manufactured by Affinity Biosensors, through its subsidiaries in Europe and Asia. Malvern will establish a co-marketing arrangement with Affinity Biosensors in North America.

Archimedes, which won the Pittcon Editors Gold Award in 2010 and an R&D100 Award in 2010, employs a unique patented technology co-invented by the Massachusetts Institute of Technology (MIT) and Affinity Biosensors. Using the technique of Resonant Mass Measurement (RMM), Archimedes detects and counts particles and determines their mass and size with high resolution and accuracy, in small sample volumes. A key area of application is the measurement of protein aggregation in biotherapeutic formulations, which provides critical information needed to speed development and improve drug safety and efficacy. Archimedes provides the technology to both count and characterize aggregates, making it invaluable to biopharmaceutical manufacturers and developers.

“We are very pleased to be involved with this exciting new technology and to be adding it to our growing range of solutions for biopharmaceutical researchers,” said Duncan Roberts, Business Development Director for Malvern. “Protein aggregation is a significant challenge in the development of protein-based drugs, and an area of increasing interest and potential regulation. Archimedes will sit alongside Malvern’s Zetasizer and Viscotek systems, all of which deliver complementary solutions for customers in this fast growing pharmaceutical industry sector.”

Affinity Biosensors’ CEO Ken Babcock commented, “Archimedes has been adopted at many leading US biopharmaceutical companies. Our partnership with Malvern will extend Archimedes’ reach worldwide, and we are glad to see it alongside Malvern’s leading materials characterization technology. Archimedes users are sure to benefit from Malvern’s world-class support and applications expertise.”

Archimedes allows precise measurement of size and mass of particles with diameters down to 50nm. Measurements are unaffected by optical or shape variations, and gentle fluidics ensure that fragile aggregates are not disrupted. The instrument can measure high viscosity samples and consumes as little as 100µl of precious protein formulation. Archimedes can accept particle concentrations up to 1x109 per ml, allowing direct study of undiluted high concentration formulations.

Archimedes can also differentiate between protein aggregates and silicone oil droplets in an injectable biopharmaceutical using buoyant mass measurement, something that no other technology can do at the submicron size scale.

Details of Malvern’s rapidly expanding range of protein characterization solutions are available at www.malvern.com/protein-aggregation, with full descriptions and specifications for the new Archimedes systems at www.malvern.com/archimedes