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

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 ...

A new 3D-printed fabrication approach means a cleanroom is now optional ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

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 ...

Researchers have found a new way to use biocatalysis to improve the production of critical raw materials required for essential drugs, making the process quicker, more efficient, and environmentally ...

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

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, ...

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 ...

A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...