03.01.23 -- 6 Risk-Mitigating Solutions For Your Biologic's Development

In today's complex world of biologics, drug developers are investing in advanced analytics much earlier in the development process. Learn why the relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

The biopharma industry is constantly advancing and innovating. Stability testing is one area that may be considered a victim of the status quo. What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

In response to the increasing biologics manufacturing industry shift into single-use closed system processing technologies, as well as increasing regulatory requirements to de-risk processes, one of our facilities is moving routine expansion of suspension cells into a closed process format. Learn about our transition and its comparison to traditional processing.

Global regulatory guidance requires drug manufacturers to implement measures to prevent, remove, and detect contaminants to ensure patient safety. A revision to the ICH Q5A guideline was needed due to the emergence of new technologies. Explore regulatory expectations for incorporating alternative methods with a focus on comparability and strategies.