Process Development

Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.

The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.

A report commissioned by FDA evaluates the QbD paradigm.

Two case studies show how advanced information technologies make process development more efficient.

Computational fluid dynamics can resolve performance problems.

Computational fluid dynamics is a powerful tool to optimize processes.

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

How will implementing Quality by Design strategies affect your compliance status?

The nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.

Regulatory flexibility can make continuous improvement possible.

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

A case study in capturing indirect costs and benefits.

Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.

QbD for QA? Try a two-step approach

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.