Across biopharmaceutical development, LC-MS has been a foundational technology for the discovery and characterization of biotherapeutic attributes—including post-translational modifications such as ...

In process monitoring is important for optimizing cell culture conditions such as nutrient concentrations, cell viability, and metabolite production as well as product quality attributes such as ...

There is limited evidence about what process attributes of clinical genetics services may be highly valued by patients and service providers. The aim in this qualitative grounded theory study was to ...

In this paper, the authors review the various analytical methods that can enable use of PAT. The success of process analytical technology (PAT), a recent initiative by FDA, depends to a large extent ...

The PAT guidance indicates a variety of risk-based approaches to managing the introduction of on-line analysers into existing processes with the aim of minimizing the regulatory burden for the ...