Protecting Protein Stability With A Novel Grade Of Sucrose
By Daniel Weinbuch and Andrea Hawe, Coriolis Pharma; Markus Greulich and Nelli Erwin, Merck KGaA, Darmstadt, Germany
Ensuring the chemical and physical stability of the therapeutic protein is critical to the safety and efficacy of biopharmaceuticals and presents one of the major challenges in formulation. A number of excipients, including sugars, can be used to solve this problem.1 Sugars are stabilizers that maintain conformational stability by preferential exclusion2 and function as cryo- and lyoprotectors in lyophilized formulations. Given these properties, it is not surprising that sucrose is one of the most widely used stabilizers in marketed drug products.3
A challenge with the use of sucrose as an excipient, however, is that nanoparticle impurities (NPI) in a size range of 100–200 nm have been detected in pharmaceutical grade sucrose.4 This white paper provides an overview of NPIs found in commercially available sucrose, their origin and impact on protein stability and describes a novel sucrose purification process designed to minimize the presence of NPIs.
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