Process Analytical Technology (PAT) Articles - BioPharm International

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Process Analytical Technology (PAT) Articles

Monitoring of Biopharmaceutical Processes: Present and Future Approaches

May 1, 2009

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)

January 1, 2009

Understanding the relationship between the process and CQAs.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1

December 1, 2008

Using multivariate experiments to define acceptable ranges.

How to Make the Business Case for Quality by Design

December 1, 2008

No time for QbD? How to convince management to make it a priority.

The New Era of Process Validation

December 1, 2008

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

How to Ensure Smooth Technology Transfer

March 1, 2008

A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.

Evaluation of Dendritic Cell Products Generated for Human Therapy and Immune Monitoring

March 1, 2008

Emerging therapies pose challenges for standardizing QC.

Presenting Data Effectively

February 1, 2008

The key to a good graphical presentation is to select the method that best fits the data.

Quality: Design Space for Biotech Products

April 1, 2007

Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.

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