Process Development

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.

The FDA's QbD pilot program is supporting good manufacturing on a global basis.

A review of some recent contributions in process chromatography.

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

Process-modeling tools can ensure smooth tech transfer.

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

More informed submissions may lead to regulatory flexibility for postapproval changes.