Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

By Jason Barker, Director of Analytical Development, Analytical Methods Transfer and Formulation Development

Scientist Using Tablet In Lab GettyImages-1354172577

As biotherapeutics continue to increase in complexity, drug sponsors must ensure regulatory compliance to receive drug approval. To develop a high-quality regulatory submission, a drug development team must procure a detailed understanding of their molecule’s structural properties and product- and process-related impurities – the defining characteristics of a protein’s identity – via advanced analytical techniques. In addition to improving compliance, a robust analytical panel will help developers gain early knowledge of a molecule’s characteristics to inform their process approach.

To guide biopharma products to approval, sponsors might consider the benefits of working with a CDMO that offer a wide array of advanced, non-platform analytical techniques. Interested in learning more? Download the full article to explore an array of advanced analytical tools that can be leveraged to de-risk processes, elucidate molecular structure, and characterize product purity all while achieving high throughput and using automation where possible.

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