Design of Experiments Gains Ground in Biopharma Development

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development, as equipment evolves and use of process analytical technology increases.

Design of experiments (DoE) is used by drug developers to gain deeper insights into their products and processes.

By using statistical methods to perform multivariate analysis, the approach allows users to assess the impact of various factors on each other and on an outcome or may make these techniques easier to apply.

Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 14–16

Citation

When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," Pharmaceutical Technology Regulatory Sourcebook eBook (December 2019).