Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development

Brown, Lynette M.; Green, Cherie L.; Jones, Nicholas; Stewart, Jennifer J.; Fraser, Stephanie; Howell, Kathy; Xu, Yuanxin; Hill, Carla G.; Wiwi, Christopher A.; White, Wendy I.; O’Brien, Peter J.; Litwin, Virginia

doi:10.1016/j.jim.2015.01.008

Cited by 32 publications

(42 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The choice of the anticoagulant will influence the assay performance and stability of the specimen [19]. For instance, EDTA binds calcium and heparin can activate certain cells [8,20,21].…”

Section: Anticoagulants Preservation Tubes and Postsample Collection Smentioning

confidence: 99%

“…For instance, EDTA binds calcium and heparin can activate certain cells [8,20,21]. The optimal anticoagulant must be determined during the method development phase [2,16,19]. Preservation tubes can be used if the sample stability is not long enough to ship a sample from the clinical site to the laboratory in a standard blood collection tube [22].…”

Section: Anticoagulants Preservation Tubes and Postsample Collection Smentioning

confidence: 99%

“…PBMCs can be isolated using density gradient centrifugation. PBMCs can be isolated and frozen directly at clinical sites; alternatively, a central laboratory can offer a s olution [19].…”

Section: Anticoagulants Preservation Tubes and Postsample Collection Smentioning

confidence: 99%

See 2 more Smart Citations

Best Practices in Performing Flow Cytometry in A Regulated Environment: Feedback from Experience Within The European Bioanalysis Forum

Strate¹,

Longdin²,

Geerlings³

et al. 2017

Bioanalysis

Self Cite

View full text Add to dashboard Cite

Flow cytometry is a powerful tool that can be used for the support of (pre)clinical studies. Although various white papers are available that describe the set-up and validation of the instrumentation (the flow cytometer) and validation of flow cytometry methods, to date no guidelines exist that address the requirements for performing flow cytometry in a regulated environment. In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications. The concepts presented here are based on the consensus of discussions in the European Bioanalysis Forum Topic Team 32, in meetings in Barcelona, Limelette and multiple telephone conferences.

show abstract

“…The choice of the anticoagulant will influence the assay performance and stability of the specimen [19]. For instance, EDTA binds calcium and heparin can activate certain cells [8,20,21].…”

Section: Anticoagulants Preservation Tubes and Postsample Collection Smentioning

confidence: 99%

Section: Anticoagulants Preservation Tubes and Postsample Collection Smentioning

confidence: 99%

See 1 more Smart Citation

Best Practices in Performing Flow Cytometry in A Regulated Environment: Feedback from Experience Within The European Bioanalysis Forum

Strate¹,

Longdin²,

Geerlings³

et al. 2017

Bioanalysis

Self Cite

View full text Add to dashboard Cite

show abstract

“…Selection of the appropriate anticoagulant requires consideration to the expression and stability of the target antigen, stability of the bound drug, as well as the anticipated time from specimen collection to testing (30). If stability of the target is not suitable in standard blood collection tubes (e.g.…”

Section: Specimen Typementioning

confidence: 99%

“…Assessment of specimen stability should be included in the validation assessment to determine the stability of the target analyte to be tested by a given antibody panel (30,43). This can be assessed by determining the level of binding present on freshly drawn specimens and by holding those specimens for a given period of time at the intended assay temperature conditions.…”

Section: Whole Blood/specimen Stabilitymentioning

confidence: 99%

Recommendations for the development and validation of flow cytometry‐based receptor occupancy assays

Green

Stewart

Högerkorp

et al. 2016

Cytometry Part B Clinical

Self Cite

View full text Add to dashboard Cite

Receptor occupancy measurements demonstrate the binding of a biotherapeutic agent to its extracellular target and represent an integral component of the pharmacodynamic (PD) portfolio utilized to advance the development and commercialization of a therapeutic agent. Coupled with traditional pharmacokinetic (PK) assessments derived from serum drug concentration, receptor occupancy data can be used to model PK/PD relationships and validate dose selection decisions throughout the drug development lifecycle. Receptor occupancy assays can be even more challenging to develop than other flow cytometric methods (e.g. surface immunophenotyping). In addition to typical considerations regarding stability of the cell type of interest, stability of the target-bound therapeutic agent and stability of the target receptor must be taken into account. Reagent selection is also challenging as reagents need to be evaluated for the potential to compete with the therapeutic agent and bind with comparable affinity. This article provides technical guidance for the development and validation of cytometry-based receptor occupancy assays. V C 2016 International Clinical Cytometry Society

show abstract

Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment

Yan¹,

King²,

Fernández‐Metzler³

2022

Bioanalytical Aspects in Biological Therapeutics

View full text Add to dashboard Cite

Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development

Cited by 32 publications

References 30 publications

Best Practices in Performing Flow Cytometry in A Regulated Environment: Feedback from Experience Within The European Bioanalysis Forum

Best Practices in Performing Flow Cytometry in A Regulated Environment: Feedback from Experience Within The European Bioanalysis Forum

Recommendations for the development and validation of flow cytometry‐based receptor occupancy assays

Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment

Contact Info

Product

Resources

About