Search results for "PAT" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
Lively, PhD, director of biopharmaceutical services, PPD; Scott Lorimer, VP Global Operations, Patheon Biologics; Eugene McNally, PhD, executive director, PPD Consulting; Rekha Patel, global director,…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Konstantinov writes that FDA is in the position to offer incentives to vendors “to develop required continuous unit operations (particularly downstream) and PAT [process analytical technology] instrum…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Tainsh and Pugh cited, as an example of innovation, liquid dispensing with process analytical technologies (PAT), such as near infrared (NIR) inspection, ultraviolet (UV) solution analysis, droplet we…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Control strategies such as process analytical technology (PAT) may be allowed for better control, a reduced NOR and, therefore, reduced variation relative to its PAR. A lower likelihood (occurrence) o…
Article
Quality by design for biotechnology products—part 1
Thus, to implement QbD, it is critical to have a fundamental understanding of the functional relationships between patient needs, product quality attributes, analytical capabilities, and the manufactu…