How to Reduce Risks in Your Biologic’s Development Process

The global biologics industry is on a roll. By 2027, it is expected to exceed a market value of €389.3B ($456.8B), a great leap from the 2019 estimate of €217.5B ($255.2B). But despite its success, failure rates in preclinical and clinical biologics drug development remain high.

Learn how to optimize your biologic’s analytical program for greater risk reduction and better chances of success!

This new report by Merck* BioReliance® discusses how risks in biologics drug development can be reduced by optimizing your biologic’s analytical program. Analytical methods are needed throughout upstream and downstream development to ensure the desired biologic is being produced with the necessary purity.

In these analytical stages, it is important to confirm that the molecule is the right one, but also to determine its quality in terms of glycosylation, oxidation, aggregates, activity, and
concentration. Moreover, the analytical package is responsible for making sure that all impurities from manufacturing processes and the environment are removed from the molecule.

biologics, analytical development

Why is the analytical process so important? Well, determining the activity and concentration of the desired biologic will ensure that it is safe for human dosing as well. Hence, this process follows Critical Quality Attributes to prevent adverse events in humans once the biologic enters clinical development.

Throughout a biologic’s development journey, numerous attributes have to be assessed through the development and implementation of analytical methods. Following these critical steps, therefore, lowers risks and increases the chances of success throughout the biologic’s journey.

But the strategy for establishing the analytical program can vary greatly, depending on the company’s stage. Here, it is essential that an appropriate balance is kept of speed, risk, and cost, while still ensuring the highest possible quality.

Learn more about the essential steps you need to take throughout your analytical program to ensure lower risks and increased chances of success for your biologic!

Header image via E. Resko, text images via Merck.

*The life science business of Merck operates as MilliporeSigma in the U.S. and Canada

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