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Ligand Binding Assays in the 21st Century Laboratory: Automation

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Fig. 1

Abbreviations

AP:

Assay plate

CFR:

Code of Federal Regulations

CO2 :

Carbon dioxide

cGMP:

Current good manufacturing practice

DOE:

Design of experiment

ELISA:

Enzyme-linked immunosorbent assay

IQ:

Installation qualification

IT:

Information technology

LBA:

Ligand binding assay

LIMS:

Laboratory information management systems

OQ:

Operational qualification

PK:

Pharmacokinetics

PQ:

Performance qualification

QC:

Quality control

RFID:

Radio frequency identification

SBS:

Society for Biological Science

USB:

Universal Serial Bus

References

  1. Morrow C. Application of automation in ligand binding assays. In: Khan MN, Findlay JW, editors. Ligand binding assays: development, validation and implementation in the drug development arena. 2010. p. 287–326.

    Google Scholar 

  2. Universal Serial Bus Specification Revision 2.0 April 27, 2000. Compaq, Hewlett-Packard, Intel, Lucent, Microsoft, NEC, Philips.

  3. Universal Serial Bus Implementers Forum, Inc. http://www.usb.org/about.

  4. Society for Biomolecular Sciences. Published Microplate Standards. ANSI/SBS 4-2004: Microplates Well Positions. Jan 9, 2004. http://www.sbsonline.org/i4a/pages/index.cfm?pageID=3598.

  5. Clinical Laboratory Improvement Amendments Act (CLIA) 42 CFR Part 493 (2004 Codification).

  6. Good Laboratory Practice Regulations (GLP) 21 CFR Part 58.

  7. Current Code of Good Manufacturing Practice 21 CFR Part 110.

  8. Food and Drug Administration Electronic Records, Electronic Signatures 21 CFR Part 11.

  9. DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885–900.

    Article  PubMed  CAS  Google Scholar 

  10. Pandya K, Ray C, Brunner L, Wang J, Lee J, DeSilva B. Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification. J Pharm Biomed Anal. 2010;53(3):623–30.

    Article  PubMed  CAS  Google Scholar 

  11. Ray C, Patel V, Shih J, Macaraeg C, Wu Y, Thway T, et al. Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J Pharm Biomed Anal. 2009;49:311–8.

    Article  PubMed  CAS  Google Scholar 

  12. Joelsson D, Moravec P, Troutman M, Pigeon J, DePhillips P. Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments. J Immunol Methods. 2008;337:35–41.

    Article  PubMed  CAS  Google Scholar 

  13. Sittampalam GS, Smith WC, Miyakawa TW, Smith DR, McMorris C. Application of experimental design techniques to optimize a competitive ELISA. J Immunol Methods. 1996;190:151–61.

    Article  PubMed  CAS  Google Scholar 

  14. United States Department of Labor OSHA Occupational Safety and Health Standard, 29 CFR Part 1910.

  15. Cacace A, Banks M, Spicer T, Civoli F, Watson J. An ultra HTS process for the identification of small molecule modulators of orphan G protein-coupled receptors. Drug Discov Today. 2003;8(17):785–92.

    Article  PubMed  CAS  Google Scholar 

  16. Webster GK, Kott L, Maloney TD. Considerations when implementing automated methods into GxP laboratories. JALA. 2005;10:182–91.

    CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. XOMA Corporation, 2710 Seventh Street, Berkeley, California, 94710, USA

    Ago B. Ahene

  2. Genentech, South San Francisco, California, USA

    Chris Morrow & Brian Sue

  3. BioAgilytix Labs, Durham, North Carolina, USA

    David Rusnak

  4. MedImmune, LLC, Gaithersburg, Maryland, USA

    Susan Spitz

  5. Thermo Fisher, Philadelphia, Pennsylvania, USA

    Joel Usansky

  6. Hamilton Company, Reno, Nevada, USA

    Holger Pils

  7. Amgen, Thousand Oaks, California, USA

    Francesca Civoli & Kinnari Pandya

  8. Tecan, Durham, North Carolina, USA

    Daniel Leach

  9. Janssen Research Development, LLC, Radnor, Pennsylvania, USA

    John Derent

Authors
  1. Ago B. Ahene
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  2. Chris Morrow
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  3. David Rusnak
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  4. Susan Spitz
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  5. Joel Usansky
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  6. Holger Pils
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  7. Francesca Civoli
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  8. Kinnari Pandya
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  9. Brian Sue
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  10. Daniel Leach
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  11. John Derent
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Corresponding author

Correspondence to Ago B. Ahene.

Additional information

Guest Editors: William Nowatzke, Ago Ahene, and Chad Ray

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Ahene, A.B., Morrow, C., Rusnak, D. et al. Ligand Binding Assays in the 21st Century Laboratory: Automation. AAPS J 14, 142–153 (2012). https://doi.org/10.1208/s12248-012-9323-z

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  • DOI: https://doi.org/10.1208/s12248-012-9323-z

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