The success of the mRNA vaccines for COVID-19 led to explosive growth in lipid nanoparticle (LNP)-mediated drug delivery for RNA vaccines and therapeutics. As these projects scale into clinical trials ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

As industry shifts to continuous biomanufacturing, engineers integrate process design, digital tools, automation, and ...

U.S. food manufacturers face a lot of challenges today. They must produce high-quality food products while using fewer ...

It's an exciting time to be in cell therapy manufacturing and commercialization, particularly in the oncology space. This year alone, we've seen the US approval of three cell therapy products: Iovance ...

Pascal Touchon serves as global strategy advisor to RoslinCT and board director, bringing over four decades of international experience in the biopharmaceutical industry, combining operational ...

Kite Pharma's viral vector plant in Southern California has been cleared for liftoff, and, with that, the Gilead Sciences company is touting its position as the only cell therapy player able to make ...

The biopharmaceutical industry is expanding rapidly, driven by an increasing demand for complex biomedicines. Today, manufacturing biomolecules presents unique challenges, like cost pressure and ...

Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer. NRx has completed confirmatory GMP audits of ...