Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...

In the last 10 years, there has been significant development in computer simulation of pharmaceutical materials, processes and product performance. Gradually, more mechanistically based models are ...

Formulation development serves as a vital bridge between a drug substance and a drug product that will remain stable and ...

Particle size, shape, surface charge, and stability can all affect texture, mouthfeel, appearance, shelf life, and processing performance. This article explores how particle characterization helps ...

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

Offers Lifecore Key Access Point into Manufacture and Fill/Finish of Next-Generation Biotherapeutic Formulations with Potential to Deliver Significant Benefits to Patients Worldwide CHASKA, Minn., Oct ...