Recommendations on ELISpot Assay Validation by the GCC

References

• Premkumar N , LowesS, JerseyJet al. Formation of a global contract research. Bioanalysis2(11), 1797–1800 (2010).
   PubMed Web of Science ®Google Scholar
• Breda N , GarofoloF, CruzCaturla Met al. The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis3(24), 2721–2727 (2011).
   PubMed Web of Science ®Google Scholar
• Lowes S , JerseyJ, ShoupRet al. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover. Bioanalysis4(7), 763–768 (2012).
   PubMed Web of Science ®Google Scholar
• Nicholson R , LowesS, CruzCaturla Met al. 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis4(19), 2335–2342 (2012).
   PubMed Web of Science ®Google Scholar
• Rocci M , LowesS, ShoupRet al. 7th GCC: use of incurred samples; fit-for-purpose validation; solution stability; electronic lab notebooks; hyperlipidemic matrix testing. Bioanalysis6(20), 2713–2720 (2014).
   PubMed Web of Science ®Google Scholar
• Bower J , FastD, GarofoloFet al. 8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation. Bioanalysis6(22), 2957–2963 (2014).
   PubMed Web of Science ®Google Scholar
• Hayes R , LeLacheurR, DumontIet al. 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks. Bioanalysis8(6), 487–495 (2016).
   PubMed Web of Science ®Google Scholar
• Cape S , IslamR, NehlsCet al. The 10th GCC closed forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud. Bioanalysis9(7), 505–516 (2017).
   PubMed Web of Science ®Google Scholar
• Islam R , BriscoeC, BowerJet al. 11th GCC closed forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation. Bioanalysis10(7), 433–444 (2018).
   PubMed Web of Science ®Google Scholar
• Briscoe C , HughesN, HayesRet al. 12th GCC closed forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability; and immunogenicity. Bioanalysis11(12), 1129–1138 (2019).
   PubMed Web of Science ®Google Scholar
• Lowes S , JerseyJ, ShoupRet al. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. Bioanalysis3(12), 1323–1332 (2011).
   PubMed Web of Science ®Google Scholar
• Sangster T , MaltasJ, StruwePet al. Recommendations on ISR in multi-analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC). Bioanalysis4(14), 1723–1730 (2012).
   PubMed Web of Science ®Google Scholar
• Boterman M , DoigM, BredaMet al. Recommendations on the interpretation of the new EMA guideline on bioanalytical method validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis4(6), 651–660 (2012).
   PubMed Web of Science ®Google Scholar
• Lowes S , BotermanM, DoigMet al. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). Bioanalysis4(17), 2117–2126 (2012).
   PubMed Web of Science ®Google Scholar
• Hougton R , GoutyD, AllinsonJet al. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis4(20), 2439–2446 (2012).
   PubMed Web of Science ®Google Scholar
• Lowes S , LeLacheurR, ShoupRet al. Recommendations on incurred sample stability (ISS) by GCC. Bioanalysis6(18), 2385–2390 (2014).
   PubMed Web of Science ®Google Scholar
• Islam R , KarS, RitzénHet al. Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis. Bioanalysis11(7), 645–653 (2019).
   PubMed Web of Science ®Google Scholar
• Nels C , BuonaratiM, CapeSet al. GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline. Bioanalysis11(18s), 1–228 (2019).
   Google Scholar
• Bower J , ZimmerJ, McCowanSet al. Recommendations for the content and management of certificates of analysis for reference standards from the GCC for bioanalysis. Bioanalysis13(8), 609–619 (2021).
   PubMed Web of Science ®Google Scholar
• Maecker HT , HasslerJ, PayneJKet al. Precision and linearity targets for validation of an IFNγ ELISPOT, cytokine flow cytometry, and tetramer assay using CMV peptides. BMC Immunology9(9), (2008). 10.1186/1471-2172-9-9
   PubMedGoogle Scholar
• Janetzki S , SchaedS, BlachereNEet al. Evaluation of ELISpot assays: influence of method and operator on variability of results. J. Immunol. Methods291, 175–183 (2004).
   PubMed Web of Science ®Google Scholar
• Britten CM , GouttefangeasC, Schoenmaekers-WeltersMJPet al. The CIMT-monitoring panel: a two-step approach to harmonize the enumeration of antigen-specific CD8+ T lymphocytes by structural and functional assays. Cancer Immunol. Immunother. doi:10.1007/s00262-007-0379-z (2007).
   Web of Science ®Google Scholar
• Cox JH , FerrariG, JanetzkiS. Measurement of cytokine release at the single cell level using the ELISPOT assay. Methods38, 274–282 (2006).
   PubMed Web of Science ®Google Scholar
• Dubey S , ClairJ, FuT-Met al. Detection of HIV vaccine-induced cell-mediated immunity in HIV-seronegative clinical trial participants using an optimized and validated enzyme-lined immunospot assay. J. Acquir. Immune Defic. Syndr.45, 20–27 (2007).
   PubMed Web of Science ®Google Scholar
• NCCLS . Performance of single cell immune response assays; approved guidelines. NCCLS document I/LA26-A (2004).
   Google Scholar
• US FDA, Center for Drug Evaluation and Research . Draft guidance for industry: Clinical immunogenicity considerations for biosimilar and interchangeable insulin products (2019). https://www.fda.gov/media/133014/download
   Google Scholar
• European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) . Guideline on Bioanalytical Method Validation. London, UK (2011).
   Google Scholar
• Janetzki S , PanageasKS, Ben-PoratLet al. Results and harmonization guidelines from two large-scale international ELISpot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol. Immunother.57, 303–315 (2008).
   PubMed Web of Science ®Google Scholar
• Piccoli S , MehtaD, VitalitiAet al. 2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3 – recommendations on 2019 FDA immunogenicity guidance, gene therapy bioanalytical challenges, strategies for critical reagent management, biomarker assay validation, flow cytometry validation & CLSI H62). Bioanalysis11(24), 2207–2244 (2019).
   PubMed Web of Science ®Google Scholar
• Corsaro B , YangTY, MurphyRet al. 2020 white paper on recent issues in bioanalysis: vaccine assay validation, qPCR assay validation, QC for CAR-T flow cytometry, NAb assay harmonization and ELISpot validation (part 3 – recommendations on immunogenicity assay strategies, NAb assays, biosimilars and FDA/EMA immunogenicity guidance/guideline, gene & cell therapy and vaccine assays). Bioanalysis13(6), 415–463 (2021).
   PubMed Web of Science ®Google Scholar
• Cox JH , FerrariG, KalamsSAet al. ELISpot Collaborative Study Group. Results of an ELISpot proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials. AIDS Res. Hum. Retroviruses21, 68–81 (2005).
   PubMed Web of Science ®Google Scholar
• Moodie Z , PriceL, GouttefangeasCet al. Response definition criteria for ELISPOT assays revisited. Cancer Immunol. Immunother.59, 1489–1501 (2010).
   PubMed Web of Science ®Google Scholar
• Hagen J , KalyuzhnyAE. Essential controls for ELISpot assay. Methods Mol. Biol.1808, 31–41 (2018).
   PubMedGoogle Scholar
• Global CRO Council for Bioanalysis (2021). http://www.global-cro-council.org
   Google Scholar