Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

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 ...

Raman Spectroscopy is an optical spectroscopy technique that provides a molecular fingerprint of a sample. Used as a practical analysis technique used inside and outside of the laboratory, Raman ...

The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set ...

The compliance process at pharmaceutical manufacturers is complicated because many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ...

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 ...

Granulation is a critical unit operation in pharmaceutical manufacturing, where fine powders are agglomerated into granules to improve flow properties, uniformity, and compaction performance. The ...

AI-driven decision engines and intelligent orchestration layers are crucial for navigating geopolitical risks and manufacturing inefficiencies in the pharmaceutical sector. Digital twins and unified ...

The Wegovy pill's approval signifies a shift from injectable to oral dosage forms, driven by patient preference for ...

Robust project management is essential in any manufacturing business, particularly where strict regulations and complex production processes require maximum alignment between all involved functions.

The EPA’s Presidential Green Chemistry Challenge award was given to Merck in 2006 for developing a green catalytic synthesis route for beta-amino acids. The EPA’s challenge award is just one example ...