Biopharmaceutical downstream processing requires precise control of multiple unit operations—from chromatography and filtration to viral inactivation—to ensure product quality and therapeutic efficacy ...

The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...

Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

Process analytical technology (PAT), a quality assurance program for the pharmaceutical industry developed by the US Food and Drug Administration, enables pharmaceutical manufacturers to control ...

Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...

As bioprocessing moves forward, companies hope to keep better track of production. A key goal is in-line analysis. This “enables continuous monitoring and control of critical process parameters in ...

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes. Process development is a key factor in the development and ...