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Immunology Core: Central Quality Assurance Unit

The Duke Center for AIDS Research (CFAR) Central Quality Assurance Unit (CQAU), (Director:M. Sarzotti-Kelsoe) was created in 2002 to implement a quality system for the HVTN Endpoint Assay Laboratories. Today, the CQAU (named currently Quality Assurance for Duke Vaccine Immunogenicity Programs, QADVIP) serves CFAR laboratories at Duke complying with GCLP in the following assays for HIV-vaccine phase I-III clinical trials immunogenicity endpoint assessmen. Examples of these are: Binding Antibody Multiplex Assays (BAMA), Enzyme-linked ImmunoSpot (ELISPOT) Assays, Neutralizing Antibody (NAb) Assays, Antibody-dependent Cell-mediated Cytotoxicity Assays (ADCC), Intracellular Cytokine Staining Assays (ICS), and Peripheral Blood Mononuclear Cell (PBMC) processing/isolation.  Additionally, the CQAU has expanded its operations within the CFAR community and to its strategic partners. This has involved monitoring/managing quality and establishing proficiency testing programs for multiple HIV vaccine consortia associated with both Duke CFAR-GAP and Duke Human Vaccine Institute (DHVI) laboratories conducting immunogenicity endpoint assays for phase I-III clinical studies (EQAPOL). The CQAU also assists laboratories conducting HIV viral isolation, culture, viral load, viral infectivity testing, sterility testing, and immunogen production (CHAVI, EQAPOL, DHVI Accessioning Unit and DHVI Protein Production Facility).

Implementing a quality system for the HVTN Endpoint Assay Laboratories.
Services Offered

Assistance with Regulations/Guidance
The CFAR CQAU can assist the laboratory in the interpretation and application of various federal and international regulations/guidance necessary for compliance to Sponsor requirements, such as ISO17043 and College of American Pathologists (CAP).

Quality Consultation
The CFAR CQAU has extensive experience in advising on implementing quality into basic research and development laboratories. This typically involves an initial site-visit of the laboratory with a report of observations and recommendations as follow-up.

GCLP Training
The CFAR CQAU can provide customized training on the applicable elements of Good Clinical Laboratory Practice as endorsed by the NIAID, RQA, and EMA.

SOP creation and Document Control
The CFAR CQAU can assist laboratories in the creation and implementation of Standard Operating Procedures and in the development of mechanisms for document control.

Certificate of Analysis (COA) Review
The CFAR CQAU offers review services of raw data, submitted in conjunction with the associated COA’s providing QA signatory approvals, compliant with GCLP and ISO/IEC.

Assay Validation
The CFAR CQAU can assist laboratories in formal process of assay/method validation following ICH Q2 (R1) and FDA guidance through training in validation, development of validation plans, planning the conduction of validation assays, and composing a validation final report.

Audit
The CFAR CQAU can perform external facility and process audits to ensure compliance to applicable regulations/guidance. An audit report detailing observations and findings is generated as a deliverable and the CQAU can follow-up with the laboratory with an audit report response form (corrective action plan) to set a timetable to compliance.

Research Highlights

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

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Core Staff Contact

(From Left to Right: Kaia Quinn Lyons, Mourine Todd, Angela McKenzie, Kelsey Hall, Brian Boykin, Marcella Sarzotti-Kelsoe, Kristen Skinner) 

Duke CFAR Central Quality Assurance Unit and
Quality Assurance for Duke Vaccine Immunogenicity Programs
2812 Erwin Rd.  Erwin Terrace II
Ste. 301
Durham, NC 27705

Marcella Sarzotti-Kelsoe, Ph.D.
CFAR CQAU Director
(919) 684-6373
marcella.sarzottikelsoe@dm.duke.edu

Angela McKenzie
CFAR CQAU Project Planner
(919) 681-7750
angela.mckenzie@duke.edu

Kristen Skinner
CFAR CQAU Coordinator
(919) 681-7790
kristen.skinner@duke.edu

Kaia Quinn Lyons, MPA
CFAR CQAU Coordinator
(919) 681-4683
kaia.lyons@duke.edu

Mourine Todd
CFAR CQAU Coordinator
(919) 684-0435
mourine.todd@duke.edu

Kelsey Hall
CFAR CQAU Coordinator
(919) 684-8272
kelsey.hall@duke.edu