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Solution Reference Standards for Protein Based Pharmaceuticals

Authors: Matthew Borer, Margaret McInerney, Kimberly Dancheck, David Lytle, Tamara Tarbox, Isil Dilek, Uma Sreenivasan, Mitzi Rettinger, Kevin Gates
Presented at 11th International Symposium on Pharmaceutical Reference Standards, Strasbourg, France, September 2012

The increasing prevalence of monoclonal antibodies and other biopharmaceuticals as drugs and drug candidates presents new challenges in pharmaceutical analysis. Many of these molecules are hygroscopic, air sensitive, highly potent, and can be impossible to isolate as neat powders without loss of biological activity. The traditional approach of using neat powders as the reference standards is therefore not the best practice for many biomolecules. Alternatives, such as lyophilized materials, are generally stable but present issues such as high cost and variability in material content from vial to vial. Lyophilized vial manufacturing can also have a higher rate of failure, which is problematic for high-value source materials such as biologics.
A solution-based reference standard is an alternative format that mitigates the handling issues associated with these materials and promotes consistency in testing. Storage in an ampouled format maintains concentration, protects from air and light, and can promote stability.

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