Testing is a key part of any product development cycle. Done right, it turns up unknown bugs and problems, and allows for them to be fixed prior to shipment. However, it can be a costly and ...

In this webcast, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. Process characterization and validation is an ...

The Intensified Design of Experiment (iDoE) approach has the potential to significantly reduce the time needed for process development and characterization. “We’ve proved iDoE on a 20 L scale and ...

Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...

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