White papers are sponsored content and is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.

White Paper — Sponsored Content

In today’s rapidly evolving landscape of manufacturing and quality assurance, the need for efficient, accurate, and compliant process validation has never been more critical. This guide will explore the evolution of process validation, the challenges and opportunities it presents, and the benefits of adopting a fully digital process-centric and data-driven approach. You will learn how to...

White Paper — Sponsored Content

Temperature mapping is vital for preserving GxP product quality during manufacturing, storage, and distribution, especially for frozen products. Warehouses pose unique challenges for temperature mapping due to their size, study duration, and seasonal variations. However, the principles for temperature mapping remain consistent, whether for warehouses, chambers, refrigerators, or freezers.

White Paper — Sponsored Content

Your Comprehensive Guide to Navigating the New USP <797> and <800> Standards.  The pharmaceutical landscape is evolving, and with it comes a set of refined standards that will impact every aspect of compounding. This white paper offers a detailed analysis to understand these changes easily and quickly. Learn about the nuanced CSP categorizations, enhanced room pressure monitoring,...

White Paper — Sponsored Content

Ultrapure water is perhaps the most prevalent ingredient in biologics manufacturing. Compared to small-molecule drugs, therapeutic proteins produced by cell culture or microbial fermentation can use as much as 10 to 100 times more water. As more and more novel biologics scale up from the lab into commercial production, there is greater pressure to generate more water with higher energy demands...

White Paper — Sponsored Content

According to the Competence Centre on Technology Transfer of the European Commission: “Technology transfer (TT) refers to the process of conveying results stemming from scientific and technological research to the marketplace and to wider society, along with associated skills and procedures, and is as such an intrinsic part of the technological innovation process.”1

White Paper — Sponsored Content

The State of Validation is the world’s first annual research report for the validation industry. Each year, State of Validation tracks a wide range of topics and metrics through surveys and interviews with validation professionals from across the globe, analyzing the trends, pitfalls, opportunities, and changes facing validation professionals like you.