Reducing Variability in Cell-Based Methods Using Process Controls
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Deadline: March 06, 2019 | Date: March 06, 2019
Venue/Country: U.S.A
Updated: 2019-02-07 15:59:38 (GMT+9)
Call For Papers - CFP
Cell-based methods are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays that use cells have unique requirements due to the variable nature of critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters helps assist laboratory scientists, laboratory managers, QC, and QA personnel identify and manage trends that could lead to OOS/OOT results. Since the number of parameters evaluated is dependent on the cell-type, assay-type, and number of critical component or reagents.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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