Additive manufacturing relies on the precise deposition and consolidation of fine powders to produce complex three-dimensional parts with tailored properties. Central to process performance is the ...

AstraZeneca study strengthens the case for microscale chromatography in biologics process characterization and manufacturing control.

Additive manufacturing (AM) encompasses a suite of layer-by-layer fabrication techniques that enable the rapid production of complex geometries from digital models. Central to the industrial adoption ...

GranuTools enhances powder understanding by offering cutting-edge physical characterization tools. Integrating years of experience in scientific instrumentation with fundamental studies on powder ...

Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

Process analytical technology in biomanufacturing has undergone a fundamental transformation over the past two decades, moving quality control from the analytical laboratory to the manufacturing floor ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

In drug development many applications are found for lipid-based nanoparticles (Lb-NPs) as successful transporters for poorly water-soluble drugs and oligonucleotides in gene therapy. Major advantages ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...

Process manufacturing is a production method in which goods are created by combining supplies, ingredients or raw materials using a predetermined formula or "recipe." The approach is frequently ...