Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

The tailor-made comprehensive offering spans a diversified clinical and commercial portfolio of innovative modalities, ...

A single type of chemical structure that shows up again and again in modern medicine is the amide bond that links a carbonyl group (C=O) to a nitrogen atom. They're so ubiquitous that 117 of the top ...

What is Pharma 4.0? The term Industry 4.0 refers to the fourth industrial revolution, associated with the application of advanced technologies that have dramatically changed the landscape of ...

Demand for GLP-1 drugs such as semaglutide is exposing capacity gaps across peptide APIs, sterile fill-finish facilities, ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...