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The AAPS Journal

, Volume 16, Issue 3, pp 504–515 | Cite as

Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

  • Lindsay E. KingEmail author
  • Esme Farley
  • Mami Imazato
  • Jeannine Keefe
  • Masood Khan
  • Mark Ma
  • K. Susanne Pihl
  • Priya Sriraman
White Paper 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

The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation.

KEY WORDS

critical reagents ligand binding assays lot changes recommendations stability 

Notes

Acknowledgments

We would like to acknowledge and thank the many scientists who provided feedback on the draft recommendations and completed the survey questionnaire. The feedback and information we received were very important in framing our final recommendations. We would also like to thank those who critically and carefully reviewed the final recommendations and manuscript.

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Lindsay E. King
    • 1
    Email author
  • Esme Farley
    • 2
  • Mami Imazato
    • 3
  • Jeannine Keefe
    • 4
  • Masood Khan
    • 5
  • Mark Ma
    • 6
  • K. Susanne Pihl
    • 7
  • Priya Sriraman
    • 8
  1. 1.Pfizer, Inc.GrotonUSA
  2. 2.Quintiles Bioanalytical LabsA Quintiles Company and ADME LabManassasUSA
  3. 3.Novartis Pharma K.K.Minato-kuJapan
  4. 4.Biogen Idec, Inc.CambridgeUSA
  5. 5.KCAS, LLCShawneeUSA
  6. 6.Amgen Inc.Thousand OaksUSA
  7. 7.H. Lundbeck A/SValbyDenmark
  8. 8.Celgene CorporationSummitUSA

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