With PAT, pharmaceutical manufacturers achieve real-time process control, enhancing drug quality and accelerating the ...

What is Real-Time Release Testing? Real-Time Release Testing (RTRT) is an advanced approach to biopharmaceutical manufacturing quality control that improves upon current systems. RTRT is defined as ...

Optimization-by-design and early process development decisions determine downstream material, energy, solvent, and water intensity, making sustainability primarily a chemistry and engineering choice ...

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined ...

The pharmaceutical industry is one of the most relevant sectors in today's economy. For more than a century, pharmaceutical production has relied on batch production, but this lacks the agility, ...

In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, ...

Fragmented plant data across silos drives late investigations and corrective action; connected architectures unify PAT, sensors, batch, quality, and maintenance signals to enable earlier risk ...

Researchers at Lawrence Livermore National Laboratory (LLNL) have modernized high-explosive (HE) manufacturing by adapting ...

What it takes to produce complex OSD drug products from the earliest stages of development to rapid, low-risk tech transfer ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...