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Biologics Analytical Methods: Trends and Strategies to Accelerate Biologics Development

Summary: Over the past several years, the growing sales and revenue of biologics points towards a shift in the pharmaceutical market. The industry is investing more into expanding biologic pipelines, thus strengthening the long-term prospects for biologic growth.

In contrast to small molecules, biologics are more diverse and mostly consist of complex mixtures that are not easily identified or characterized. During the development of bioanalytical methods, the speed of analysis, method sensitivity and robustness are all considered as key elements to meet rigorous criteria requested by regulatory authorities for a validated method.

This webinar summarizes the current bioanalytical landscape and its challenges, and discusses strategies to overcome them. Experts describe how the stepwise approach for bioanalytical testing can be used to reduce risks and challenges present in biologics development. In addition, we also discuss how the bioanalytical plans can be tailored to fit study needs at all project stages and its implications for CMC regulatory submission of biologic products.

Learn more about:

• An introduction to the analytical testing landscape, and Catalent’s stepwise approach for analytical testing
• Common challenges in analytical testing of biologics programs, and strategies to overcome them
• Regulatory strategy of biologic development plans with a focus on analytical development packages

 

Click here to download the Webinar