The AAPS Journal

, Volume 16, Issue 1, pp 164–171 | Cite as

Automation Practices in Large Molecule Bioanalysis: Recommendations from Group L5 of the Global Bioanalytical Consortium

  • Ago Ahene
  • Claudio Calonder
  • Scott Davis
  • Joseph Kowalchick
  • Takahiro Nakamura
  • Parya Nouri
  • Igor Vostiar
  • Yang Wang
  • Jin Wang
Brief/Technical Note Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium
Part of the following topical collections:
  1. Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium

Abstract

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.

KEY WORDS

automation documentation large molecule bioanalysis robotic system 

Notes

Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  • Ago Ahene
    • 1
  • Claudio Calonder
    • 2
  • Scott Davis
    • 3
  • Joseph Kowalchick
    • 4
  • Takahiro Nakamura
    • 5
  • Parya Nouri
    • 6
  • Igor Vostiar
    • 7
  • Yang Wang
    • 8
  • Jin Wang
    • 9
  1. 1.XOMA (US) LLCBerkeleyUSA
  2. 2.Novartis Institute for Biomedical ResearchBaselSwitzerland
  3. 3.PPDRichmondUSA
  4. 4.Janssen Research & Development, LLCRadnorUSA
  5. 5.Shin Nippon Biomedical Laboratories, LtdKagoshimaJapan
  6. 6.Pfizer, IncGrotonUSA
  7. 7.Novartis Pharma AGBaselSwitzerland
  8. 8.Janssen Research & DevelopmentShanghaiChina
  9. 9.AmgenThousand OaksUSA

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