A steady increase of product titers and the corresponding change in impurity composition
represent a challenge for development and optimization of antibody production processes …

Quality by design (QbD) has been receiving a lot of attention in the pharmaceutical
community of late. Successful QbD implementation requires a thorough understanding of the …

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FMEA is a systematic method of identifying and preventing system, product and process
problems before they occur. It is focused on preventing problems, enhancing safety, and …

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical
processes following a Quality by Design (QbD) approach, there have been many …

Most biotechnology unit operations are complex in nature with numerous process variables,
feed material attributes, and raw material attributes that can have significant impact on the …

Implementing real‐time product quality control meets one or both of the key goals outlined in
FDA's PAT guidance:“variability is managed by the process” and “product quality attributes …

This review focuses on recent progress in the technology of high throughput (HTP)
cultivation and its increasing application in quality by design (QbD)-driven bioprocess …

In the post-genomic era, the demand for faster and more efficient protein production has
increased, both in public laboratories and industry. In addition, with the expansion of protein …

Over the last years, the pharmaceutical industry has faced real challenges regarding quality
assurance. In this context, the establishment of more holistic approaches to the …