Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

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

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.