Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

In this age of technology, the vision of manufacturing industries built of smart factories is not
a farfetched future. As a prerequisite for Industry 4.0, industrial sectors are moving towards …

Quality by design for biopharmaceuticals | Nature Biotechnology Skip to main content Thank
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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 …

Abstract The “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st
Century—A Risk Based Approach” initiative announced by the FDA in August 2002 to …

Process monitoring systems are necessary for ensuring the long-term reliability of the
operation of industrial systems. This article provides some perspectives on progress in the …

Bioprocess scale‐up is a fundamental component of process development in the
biotechnology industry. When scaling up a mammalian cell culture process, it is important to …

This article provides a perspective on control and operations for biopharmaceutical
manufacturing. Challenges and opportunities are described for (1) microscale technologies …

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 …

With recent advances in digitisation and big data analytics, more pharmaceutical firms are
adopting digital tools to achieve modernisation. The biological phenomena within …