Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

After its founding in 1976, scientists at Genentech worked methodically toward the development of its first biotechnology product. It was nearly a decade later that the FDA approved Protropin, a ...