Article | May 11, 2020

Meeting Stability Testing Expectations In Today's Complex Pharma Landscape

By Daniel Galbraith, Director of Global Product Characterization, MilliporeSigma

Vial analysis

The biopharma industry is constantly advancing and innovating, but what does this mean for processes? Standard approaches are not viable long term due to regulatory changes, more cutting-edge drugs, and new markets. Stability testing is one area that may be considered a victim of the status quo, and this can be misleading because higher expectations are being placed on data quality. Specifically, the regulatory demands are focused on extensive and in-depth analysis more than ever before. This amplifies the responsibility of drug developers to evaluate testing and optimize processes, resulting in complex processes for manufacturers to confirm the quality, efficacy, and safety of drug formulations. A framework for stability studies exists; however, specific testing requirements vary considerably between markets. So, how can drug developers mitigate risks, avoid costly mishaps, and stay current? Let’s explore these questions and their impacts.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of BioProcess Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: