Search results for " identity"

Article Regulatory Challenges in the QbD Paradigm
This section also describes the need for conducting appropriate validation, including clinical and nonclinical studies to demonstrate that the change has no adverse effect on the identity, strength, q…

Article QbD and PAT in Upstream and Downstream Processing
NMR could change the face of bioprocess development and monitoring because it provides access to component identity, plus quantitative data, rapidly and easily from a single analysis. NMR profiling ca…

Article Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.  ABSTRACT The use of small-interf…

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