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

Adam Kovalčík, age 19, innovated a cheaper, faster way to produce an antiviral drug. Galidesivir targets RNA viruses like COVID-19, Ebola, and Zika but hasn't completed clinical trials. Kovalčík won a ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

HRV Pharma’s innovative “virtual manufacturing” model connects FDA-approved facilities to prevent prescription shortages and ...

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a grant worth up to $35 million over the next five years to improve drug ...

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, ...

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 ...

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...

Antibiotic factories release resistance genes at levels 100x higher than city sewage. Pharmaceutical pollution is fueling ...