New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

An international team of researchers led by the University of California San Diego has developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are ...

Adam Kovalčík showed off a poster about his research at the Regeneron International Science and Engineering Fair in Columbus, Ohio.Chris Ayers Photography/Licensed by Society for Science When Adam ...

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...

From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

The pharmaceutical contract manufacturing market is driven by increased outsourcing of complex processes to CMOs, enabling ...

Scientists have developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are commonly used to manufacture protein-based drugs for treating cancer, ...