01.12.21 -- What You Need To Know To Avoid Costly Delays In Your API Scale-Up

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.

To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

This presentation highlights how innovative protein analysis technologies have been adopted for better comparability, release testing, and impurity monitoring to improve characterization and productivity.

Greg Sears, Ph.D., Global Director, Process Characterization, Head of Manufacturing Science & Tech, Pharma Services, Biologics at Thermo Fisher Scientific, discusses process characterization basics.