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Hospitals Management

February 2013, e-Newsletter
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KnowledgeBank
Ambient Stable Biologics - Stable Aqueous Erythropoietin

Challenge
Erythropoietin (EPO) is known to aggregate under heat stress, which prevents storage of liquid compositions at ambient temperature. The key challenge of this study was to demonstrate that the application of the ArestatT tools can reduce significantly aggregation of EPO at an elevated temperature, compared with a marketed liquid formulation

ArestatT solution
A liquid EPO product was reformulated and the key parameters, such as pH, osmolality and the nature of the surfactant were kept unchanged in the new formulation. The critical change was the nature of the buffering species, which were selected to ensure minimal proton exchange between the protein molecule and excipients, and to minimise hydrophobic interactions. Incubation of the currently marketed EPO formulation at 40°C for 24 weeks resulted in considerable (>50%) high molecular weight species formation (HMWS, measured by size-exclusion chromatography). In contrast, the reformulated EPO, using the ArestatT alternative buffering species, showed virtually no aggregation following the same treatment.
The rate of aggregation of EPO (82 µg/ml) at 40°C in ArestatT formulation compared with the control.

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Industry Updates
News
Elcelyx Therapeutics Completes $20 Million Series C Financing to Advance NewMet and Lovidia
SAN DIEGO, Feb. 14, 2013
Elcelyx has raised a total of $43 million since it was founded in 2010 and advanced its two first-in-class Gut Sensory Modulators (GSM) for the treatment of diabetes and weight loss into late-stage clinical development.
Press Release
Research and Markets: Other Cancer - Pipeline Review, H2 2012
Thursday 14 Feb, 2013
DUBLIN Research and Markets has announced the addition of Global Markets Direct’s new report “Other Cancer - Pipeline Review, H2 2012” to their offering.
Events and Exhibition
4th Drug Delivery and Formulation 2013
Feb 18 2013 - Feb 20 2013

Maritim ProArte
Hotel Berlin
Germany
World Trade Group Limited
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