Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

What are some real-life SIPOC applications in the field of manufacturing? While Lean Six Sigma tools and methodologies can be applied to any industry, they truly excel when pointed toward something ...

The successes seen in a number of clinical studies on viral vector-based gene therapies (AAV, retroviral, and lentiviral vectors) are well documented, with an ever-broadening pipeline of products ...

In the lab, various phases of drug development occur in life sciences as new drugs and therapies are discovered and developed through extensive research. Labs are then used to ensure quality control ...

A "deviation" in manufacturing is when manufacturing steps are changed in some way from the set guidelines. Production guidelines are very detailed based on supply contract specifications, product ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

This new article publication from Acta Pharmaceutica Sinica B, discusses an AI-integrated quality prediction and diagnostics framework that could transform small-sample pharmaceutical manufacturing ...

Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.

Will Kenton is an expert on the economy and investing laws and regulations. He previously held senior editorial roles at Investopedia and Kapitall Wire and holds a MA in Economics from The New School ...