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European Biopharmaceutical Review

Protein Productivity

The marginal stability of proteins substantially complicates the safe and efficacious delivery of biopharmaceuticals, making the investigation and control of stability a primary focus throughout product development. Liquid – as opposed to lyophilised – formulations offer the significant clinical advantage of greater ease of administration and are generally the preferred option for delivering biologics. However, they are challenging from the perspective of stability.

Identifying the excipients and handling strategies that maximise the physical stability of a candidate molecule and minimise any chemical degradation is an essential task. Analytical tools that enable the confident assessment and prediction of stability are consequently of significant value to formulators, especially when they provide data that correlate well with the accelerated or long-term stability studies required ahead of regulatory approval.

There is widespread recognition within the industry that, when it comes to comprehensively understanding stability, no singular approach holds all the answers. Rather, an array of orthogonal techniques is needed. Selecting a suite of the most relevant and informative methods is crucial as stability investigations ramp up from pre-formulation onwards, but so too is understanding how to rationalise what can be extensive and non-converging datasets.

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Lisa Newey-Keane is the Life Sciences Sector Marketing Manager for Malvern Instruments, based at the company’s head office in Britain. She holds a PhD in microbiology/ protein biochemistry from the University of Birmingham, UK, and her industry background is within contract manufacture and research, primarily for biopharmaceuticals and anti-infectives.
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Lisa Newey-Keane
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