Biopharmaceutical downstream processing requires precise control of multiple unit operations—from chromatography and filtration to viral inactivation—to ensure product quality and therapeutic efficacy ...
BOSTON--(BUSINESS WIRE)--908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, announces the launch of MAVERICK, an optical in ...
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 ...
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 ...
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...
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 ...
A “digital bioprocess replica” is, as the name suggests, a computer model of a bioprocess. The aim is to simulate the entire process, including all critical parameters and quality attributes, to ...
Pharmaceuticals have a prominent role in healthcare, and their manufacturing requires innovative tools and scientific and engineering knowledge, and must at the same time comply with strict ...
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