White Paper

The Importance Of End-To-End Thinking During Drug Product Development

By Dr. Kashif Ghaffar, Pharmacist for Process Validation, Pfizer CentreOne

Healthcare data

During early drug development there is a tendency to adopt a ‘fit-for-purpose’ strategy when producing formulations for clinical trials. This approach is understandable considering that only one in ten compounds that enter clinical trials will become registered products. Nevertheless, it is important to build in robustness for manufacture early in development and to prepare for scale-up.

There may be reasons for changing formulation or process strategy during early product development (e.g. direct compression to granulation approach). As a result, being agile through having access to a broad range of processing equipment with scale-up capability is extremely advantageous.

The use of continuous processing strategies, such as roller compaction and continuous mixing, offer great potential for batch size flexibility. For larger batch sizes you simply run the process for longer. The FDA’s ‘scale-up and post approval changes’ (SUPAC) guidelines1,2 provide a useful framework for manufacturing scale-up and it is highly beneficial if equipment of the same SUPAC class is available for development, scale-up and commercial manufacturing.

Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

VIEW THE WHITE PAPER!
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 Pharmaceutical 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: