The process of building a cell or gene therapy can be long and complex, with substantial challenges encountered on the road to regulatory approval. A drug developer can enhance their chance of success ...

One billion dollars. That can be the list price for bringing a new cancer-fighting agent from preclinical design through approval by the US Food and Drug Administration, according to Michael R. Grever ...

Drug development is an unforgiving business. Discovering a novel molecule is difficult enough, but then it can take years of preclinical studies and molecular tweaking to mitigate a drug’s toxicity, ...

The vast majority of drug compounds fail in the preclinical stage, and pharmaceutical and biotech companies are continuously looking for preclinical process improvements to better manage costs and ...

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 ...

Over the past year, drug discovery has gotten a massive boost from the CAS BioFinder Discovery Platform, which allows scientists to explore known and predicted data that accelerate the preclinical ...

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced a strategic partnership with Kibur Medical to offer exclusive access to its implantable ...

At the heart of this approach is the integration of real-time analytical techniques with process control systems, a capability that underpins both PAT and Quality by Design (QbD) frameworks. In this ...