Article | October 4, 2021

The Importance Of CMC Developability Assessments: A Conversation With AltruBio's Dr. Gene Lee

Source: Cytiva

By Cytiva

iStock-1293772969-lab-microscope-scientist-research

A great deal of trust is required when launching a drug’s clinical development – trust in a molecule, a process, facilities and teams, and a therapy’s ultimate potential. And this trust is built at the earliest stages, while a solid business case and fundamental science are inspiring confidence and encouraging investment.

The business case for any therapeutic starts with a chemistry, manufacturing, and control (CMC) developability assessment, according to Dr. Gene Lee, Vice President of Technical Development at AltruBio. Dr. Lee says Performing a CMC assessment is not unlike building a car. Both require taking a concept from design to prototype. He shares, “You build several versions of those early designs. See if they work; put them out on the racetrack; see what kind of range they have. Not all designs are going to work well.”

Dr. Lee discussed getting the developability question right and why it’s important to understand your end game as early as discovery in a recent episode of The Business of Biotech, produced by BioProcess Online and supported by Cytiva.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Bioprocess Online? Subscribe today.

Subscribe to Bioprocess Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Bioprocess Online