White Paper

Taking Charge Of Your Stability Program

By Pamela Hamill, Ph.D.; Amy Glekas, Ph.D.; Greg Pirozzi, Ph.D.

Handshake GettyImages-1174007938

Conducting stability studies is a critical aspect of the drug development process, as the information gained determines key clinical development decisions and becomes an essential component of the submission package required by regulatory authorities globally. For any biological therapy, there is a set of attributes that is critical to maintaining the product’s safety and efficacy; the purpose of stability studies is to analyze these attributes at predetermined timepoints during the study to understand how they may be impacted by storage in different environmental conditions.

With the high costs and long timelines needed to bring a drug to market, improving efficiency and reducing risk wherever possible can accelerate your product development and de-risk complex studies such as stability. Learn how consolidating stability testing with a single partner offers these benefits and more.

access the White Paper!

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 Biosimilar Development? Subscribe today.

Subscribe to Biosimilar Development X

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


Subscribe to Biosimilar Development