Keys to Successful Method Transfer

Mechanistic toxicity hypotheses is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The author highlights the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

This article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.