Process Control, Automation, and PAT

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

This article presents first-hand perspectives from industry users to suppliers of single-use sensors.

MedicalRF.com/Science Photo Library-ANDRZEJ WOJCICKI/Henrik Jonsson/Stocktrek Images; Dan Ward

FDA provides recommendations for submitting analytical procedures and methods validation data.

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.

The authors review the various analytical methods that can enable use of PAT.

The authors discuss the technology and guidance required to achieve good KM in a biopharmaceutical company.

Combine cost analyses with QbD to improve operations and lower costs.

To speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how.

To assess current trends in information technology, automation, and process control, BioPharm International turned to Rick E. Cooley, market development manager?process analytics, Dionex Corporation, and James Erickson, president and chief executive officer, Blue Mountain Quality Resources, Inc.

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.

Understanding the relationship between the process and CQAs.

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

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

Using multivariate experiments to define acceptable ranges.

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

Emerging therapies pose challenges for standardizing QC.

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

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit.

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