A pioneering research and training institute is promoting the benefits of measuring multiple quality attributes simultaneously during biologics manufacturing. Ireland’s National Institute for ...

In nearly all regions and industries, markets for products reflect the impact of globalization. The tactic of competing on price is increasingly giving way to a wider range of factors—including ...

Biotherapeutics require extensive characterization and quality control (QC) testing prior to product release. These tests are resource intensive, time-consuming, and require updating as manufacturing ...

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer. The QbD paradigm performs a risk assessment during ...

There is high consumer demand globally for salmon, as it is a popular fish. This demand has generated a requirement for efficiency from the raising of salmon to its processing in the plant. Rapid ...

The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives. The US Food and Drug Administration's Office of Generic Drugs (OGD) and ...

Authors explore complexities in scaling gene-therapy production with special attention is to monitoring and enhancing ...