The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs. The 27-page draft guidance is ...

The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at ...

At INTERPHEX 2026, David Chau and Stuart Tindal discuss automation, single-use durability challenges, and the shift to ...

In recent years, fed-batch biomanufacturing has begun giving way to continuous manufacturing processes, as developers face pressure to balance affordability with high manufacturing quality. Although ...

Interest in intensified manufacturing is driving innovation in downstream technologies, according to the team behind a new predictive freeze-drying model designed with continuous processes in mind.

The U.S. Food and Drug Administration (FDA) will hold a virtual 2023 NanoDay symposium on October 11, 2023, on the continuous manufacturing of nanomaterials. In the symposium, FDA will provide an ...

The antibiotic cefazolin is an essential drug according to the World Health Organization (WHO). It is usually produced via batch manufacturing, but this multistep process is time-consuming, wasteful ...

Biologics manufacturing is entering a new phase where agility and proximity matter as much as scale. For decades, the industry relied on the philosophy that “bigger is better,” constructing massive, ...

This activity was supported by Contract/Grant No. HHSP233201400020B between the National Academy of Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or ...

Historically, making medical devices has been a complicated task, often due to the sheer number of parts produced, all in differing sizes and complexities. When you take into consideration the added ...