The AAPS Journal

, Volume 14, Issue 1, pp 105–112 | Cite as

Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

  • Sheldon S. Leung
  • Joel Usansky
  • Robert Lynde
  • Theingi Thway
  • Robert Hendricks
  • David Rusnak
Commentary Theme: Ligand Binding Assays in the 21st Century Laboratory

KEY WORDS

21 CFR Part 11 automated data interchange common data standard ligand-binding assays metadata 

ABBREVIATIONS

API

Application programming interface

ERES

Electronic Records and Electronic Signatures regulations (US FDA 21 CFR Part 11)

GLP

Good Laboratory Practice regulations (21 CFR Part 58)

GUID

Globally unique identifier

IT

Information technology

LBA

Ligand-binding assay

LC/MS

Liquid chromatography/mass spectrometry

LIMS

Laboratory information management system

SDK

Software development kit

USB

Universal serial bus

Notes

ACKNOWLEDGMENTS

The authors would like to acknowledge Jim King’s efforts in initiating this effort, Chad Briscoe’s participation on this subcommittee, and Ago Ahene, Marian Kelley, Denise O’Hara, Jean Lee, and Philip Oldfield for their review and comments. This manuscript was prepared by members of the 21st Century Bioanalytical Laboratory: eSolutions Subcommittee of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG).

Conflict of interest

This article describes two commercial systems: MasterPlex® from Hitachi Solutions America and Integration Manager from Thermo Scientific. Robert Lynde and Joel Usansky are employees of Hitachi Solutions America and Thermo Scientific, respectively. These two systems were provided as examples of commercially available systems that do not provide a complete solution. To the authors’ best knowledge, due to the lack of a universally accepted automated data interchange process, there are currently no commercially available systems that provide the complete solution that we seek.

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Sheldon S. Leung
    • 1
  • Joel Usansky
    • 2
  • Robert Lynde
    • 3
  • Theingi Thway
    • 4
  • Robert Hendricks
    • 5
  • David Rusnak
    • 6
  1. 1.Pfizer Inc.AndoverUSA
  2. 2.Thermo Fisher ScientificPhiladelphiaUSA
  3. 3.Hitachi Solutions America, Ltd.South San FranciscoUSA
  4. 4.Amgen Inc.Thousand OaksUSA
  5. 5.Genentech Inc.South San FranciscoUSA
  6. 6.BioAgilytix Labs, Inc.DurhamUSA

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