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Automation practices in large molecule bioanalysis: Recommendations from group l5 of the global bioanalytical consortium

Ahene, A, Calonder, C, Davis, S, Kowalchick, J, Nakamura, T, Nouri, P, Vostiar, I, Wang, Y and Wang, J (2014) Automation practices in large molecule bioanalysis: Recommendations from group l5 of the global bioanalytical consortium. AAPS journal. pp. 164-171.


In recent years, the use of automated sample handling instrumentation has come to the forefront of bioanalytical analysis in order to ensure greater assay consistency and throughput. Since robotic systems are becoming part of everyday analytical procedures, the need for consistent guidance across the pharmaceutical industry has become increasingly important. Pre-existing regulations do not go into sufficient detail in regard to how to handle the use of robotic systems for use with analytical methods, especially large molecule bioanalysis. As a result, Global Bioanalytical Consortium (GBC) Group L5 has put forth specific recommendations for the validation, qualification, and use of robotic systems as part of large molecule bioanalytical analyses in the present white paper. The guidelines presented can be followed to ensure that there is a consistent, transparent methodology that will ensure that robotic systems can be effectively used and documented in a regulated bioanalytical laboratory setting. This will allow for consistent use of robotic sample handling instrumentation as part of large molecule bioanalysis across the globe. 2013 American Association of Pharmaceutical Scientists

Item Type: Article
Additional Information: NIBR author: Calonder, C institute: NIBR contributor address: (Ahene) XOMA (US) LLC, Berkeley, CA, United States (Calonder) Novartis Institute for Biomedical Research, Basel, Switzerland (Davis) PPD, 2240 Dabney Rd, Richmond, VA 23230, United States (Kowalchick) Janssen Research and Development, LLC, Radnor, PA, United States (Nakamura) Shin Nippon Biomedical Laboratories, Ltd, Kagoshima, Japan (Nouri) Pfizer, Inc, Groton, CT, United States (Vostiar) Novartis Pharma AG, Basel, Switzerland (Wang) Janssen Research and Development, Shanghai, China (Wang) Amgen, Thousand Oaks, CA, United States
Date Deposited: 13 Oct 2015 13:12
Last Modified: 13 Oct 2015 13:12