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European Biopharmaceutical Review

Definitive Screening Designs

The ability to quickly develop reliable and robust analytical test methods is an important aspect of navigating the technical path to a successful investigational new drug (IND) submission. Often, an insufficient amount of time is allocated to understanding analytical methods and reference materials and how they perform at in-process test points.

Charge Heterogeneity

Analytical comprehension is particularly challenging for proteins expressed in mammalian cells, which can present extensive charge heterogeneity resulting from variations in post-translational modifications (PTMs). The milieu parameters in any given bioprocess can impact charge heterogeneity, which, when not properly understood and controlled, can cause unwanted batch-to-batch variation in product quality.

Therefore, early detection of charge heterogeneity, using a robust method with good resolution, is an important capability for process development. Some PTMs result in charge differences on the molecule that are likely to alter the protein’s stability or activity.

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Dr Srividya Suryanarayana has over five years’ industry experience at Cytovance Biologics and over seven years’ academic experience in R&D. She is a subject matter expert on charge-based analytical methods using icIEF and has a strong background in enzymology, protein biochemistry, analytical method development, qualification and validation. Srividya is a method validation lead scientist in Quality Control at Cytovance Biologics, leading method validation activities for several client-specific projects. She holds a PhD in biochemistry/biophysics from the University of Kansas, US, and has completed post-doctoral training from the Medical College of Wisconsin, US.
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Dr Srividya Suryanarayana
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