This publication details the “harmonization” efforts between NIAID GCLP and RQA GCLP, which was led by the CFAR CQAU.
Sarzotti-Kelsoe M,, Cox J., Cleland N., Denny T., Hural J., Needham L., Ozaki D., Rodriguez-Chavez I.R., Stevens G., Stiles T., Tarragona-Fiol T., Simkins A. Evaluation and Recommendations on Good Clinical Laboratory Practice (GCLP) Guidelines for Phase I-III Immunol resClinical Trials. PLoS Medicine 2009, 6(5): e1000067.
This publication details the establishment of an international proficiency testing program for the Neutralzing Antibody Assay for HIV-1 in TZM-bl Cells.
Todd C, Yu X, Ozaki DA, Greene KM, Gao H, Wood B, Wang M, Gilbert P, Montefiori DC, Sarzotti-Kelsoe M. Development and Implementation of an International Proficiency Testing Program for a Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells. J Immunol Methods. 2011, Sep 22, 2012; 375 (1):57.
This publication details technology transfer of the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells to an international network of laboratories operating under GCLP compliance.
Ozaki D.A., Gao H., Todd C.A., Greene K.M., Montefiori D.C., Sarzotti-Kelsoe M. International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials. PLoS One. 2012, 7(1):e30963.
This publication details the various steps of establishing an international quality assurance program to oversee the integrity of PBMCs’ collection and long-term storage.
Sarzotti-Kelsoe M, Needham LK, Rountree W, Bainbridge J, Gray CM, Fiscus SA, Ferrari G, Stevens WS, Stager SL, Binz W, Louzao R, Long KO, Mokgotho P, Moodley N, Mackay M, Kerkau M, McMillion T, Kirchherr J, Soderberg KA, Haynes BF, Denny TN. The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells. J Immunol Methods. 2014 Jul; 409:21-30.
This publication details the steps taken to implement GCLP in domestic laboratories previously operating in a research and development environment, as part of an NIH-funded contract.
Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014 Jul; 409:91-8.
This publication details the validation efforts led by the CFAR CQAU for the Neutralizing Antibody Assay for HIV-1 in A3R5 Cells.
Sarzotti-Kelsoe M, Daniell X, Todd CA, Bilska M, Martelli A, LaBranche C, Perez LG, Ochsenbauer C, Kappes JC, Rountree W, Denny TN, Montefiori DC, Optimization and validation of a neutralizing antibody assay for HIV-1 in A3R5 cells Kappes JC, Rountree W, Denny TN, Montefiori DC. J Immunol Methods. 2014 Jul; 409:147-60.
This publication details the validation efforts led by the CFAR CQAU for the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells.
Sarzotti-Kelsoe M, Bailer RT, Turk E, Lin C, Bilska M, Greene KM, Gao H, Todd CA, Ozaki DA, Seaman MS, Mascola JR, Montefiori DC, Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1, J Immunol Methods. 2014 Jul; 409:131-46.
This publication details the validation efforts led by the CFAR CQAU for the Qualified Biolayer Interferometry Avidity Measurements of Malaria-specific antibodies.
Dennison SM, Reichartz M, Seaton KE, Dutta S, Wille-Reece U, Hill AVS, Ewer KJ, Rountree W, Sarzotti-Kelsoe M, Ozaki DA, Alam SM, Tomaras GD. Qualified Biolayer Interferometry Avidity Measurements Distinguish the Heterogeneity of Antibody Interactions with Plasmodium falciparum Circumsporozoite Protein Antigens. J Immunol. 2018 Aug 15; 201(4):1315-1326