Essential Quality Metrics for Immune Cell Biospecimens in Translational Research

Photo Credit: National Institute of Allergy and Infectious Diseases (NIAID)

Immune cell biospecimens are the cornerstone of modern immunological research, offering unparalleled insight into cellular function, therapeutic development, and disease mechanisms. But the integrity and quality of these materials directly affect experimental reproducibility, data interpretation, and ultimately the success of translational research.

As multi-parameter flow cytometry, single-cell sequencing, and functional assays grow more sophisticated, the demand for rigorously characterized biospecimens has never been higher. The transition from basic research to clinical applications requires biospecimens that meet stringent quality standards across multiple parameters.

Whether you are developing next-generation CAR-T therapies, investigating novel oncology biomarkers, or profiling immune responses in infectious disease, you must consider cell viability, phenotypic stability, functional competence, and annotation quality. At Sanguine, our direct-to-donor model and comprehensive QC protocols ensure that every specimen — from Human PBMCs to specialized Human CD56+ NK Cells — meets the standards required for publication-quality research and regulatory submissions.

Understanding Critical Quality Parameters for Immune Cell Products

Cell viability is the fundamental quality metric for all immune cell biospecimens, but it is only the starting point. Post-thaw viability for cryopreserved Human PBMCs should consistently exceed 85% when measured by trypan blue exclusion or 7-AAD flow cytometry within 24 hours of thawing.[1] Viability alone does not guarantee functional competence — cells may exclude vital dyes yet show compromised proliferation, cytokine production, or receptor expression.

Functional viability assessments give a fuller picture of cellular health. For Human CD3+ T Cells, stimulation assays using anti-CD3/CD28 beads should show robust proliferation and cytokine secretion (IL-2, IFN-γ, TNF-α) comparable to freshly isolated cells.[2] Similarly, Human CD56+ NK Cells must retain cytotoxic function against standard target lines (K562), with specific lysis above 40% at 10:1 effector-to-target ratios after cryopreservation.[3] These functional benchmarks ensure downstream outcomes reflect true biology rather than processing artifacts.

Phenotypic stability is another essential dimension, especially for multi-parameter immunophenotyping. Surface marker expression can be significantly altered by improper handling, extended processing times, or suboptimal cryopreservation. When working with Human Leukopak preparations, verify that major subsets — CD4+ T cells, CD8+ T cells, B cells, NK cells, and monocytes — maintain expected proportions and marker profiles post-processing.[4] Sanguine’s standardized protocols include comprehensive immunophenotyping data with every cellular product.

Quality Control in Apheresis-Derived Products

Human Leukopak products offer exceptional cellular yields but require rigorous quality assessment for consistency. Total nucleated cell (TNC) counts should fall within predefined ranges (typically 1–5 × 10^10 cells per standard leukapheresis), with mononuclear cell enrichment exceeding 90% after density gradient centrifugation.[5] Red blood cell contamination must be minimized to prevent oxidative stress and hemoglobin-mediated interference in colorimetric assays.

The apheresis collection process itself introduces variables that affect quality. Anticoagulant choice (ACD-A, sodium citrate, or heparin) affects subsequent isolation and functional assay performance.[6] Processing time from collection to cryopreservation should not exceed 24 hours for optimal viability, though some protocols extend this window with media supplementation and temperature control. Sanguine’s same-day collection and shipping protocols minimize delays, preserving function and reducing activation-induced changes.

For clinical-grade materials, GMP Leukopak products must meet additional standards including sterility testing, mycoplasma screening, endotoxin quantification, and full batch documentation.[7] These enhanced specifications support IND-enabling studies and clinical trial applications where regulatory compliance is paramount. Our custom collection services accommodate study-specific requirements, from specialized protocols to tailored QC panels.

Plasma and Serum Quality Considerations

Blood-derived biofluids are essential matrices for biomarker discovery and validation, and their quality is profoundly influenced by pre-analytical variables. Human Plasma collected in EDTA, citrate, or heparin tubes shows distinct protein stability profiles, affecting downstream proteomic, metabolomic, and cytokine analyses.[8] Hemolysis — rupture of red cells during collection or processing — introduces intracellular proteins and can artificially elevate numerous analytes, confounding interpretation.

Processing time is a critical variable in plasma quality. Platelet activation occurs rapidly after venipuncture, releasing proteins and bioactive molecules that alter the biological profile.[9] Centrifugation within 2 hours of collection is optimal for most applications, though specific questions may require different handling. Human Serum preparation involves an intentional clotting step, producing a biofluid depleted of coagulation factors but enriched in clot-derived proteins — advantageous for certain immunoassays but potentially confounding for others.

Freeze-thaw cycles dramatically impact biofluid quality, with each cycle potentially degrading labile proteins, activating proteases, and altering metabolite concentrations. Single-aliquot strategies minimize freeze-thaw exposure but require careful initial volume planning. Sanguine’s comprehensive genomic annotation accompanies every plasma and serum sample, documenting collection conditions, processing times, anticoagulant type, and storage history.

Whole Blood: Fresh and Cryopreserved Considerations

Human Whole Blood is the most physiologically relevant specimen for certain applications, maintaining cell-cell interactions and in vivo cellular ratios. Fresh whole blood enables real-time functional assays — phagocytosis, oxidative burst, and degranulation — that require intact cellular interactions.[10] But whole blood has limited stability, with significant cellular activation and gene expression changes within hours of collection.

Anticoagulant selection strongly affects whole blood assay performance. EDTA chelates calcium and inhibits most coagulation factors but can affect certain surface epitopes. Heparin preserves calcium-dependent processes but may interfere with PCR-based assays. Sodium citrate offers a balance for many applications but dilutes the specimen by 10%.[11] Align anticoagulant choice with both immediate cellular function and downstream analytical compatibility.

Temperature control during transport is another critical variable. Lymphocyte activation cascades initiate at elevated temperatures, altering gene expression and surface marker density.[12] Overnight ambient shipment may be acceptable for some assays but proves suboptimal for sensitive gene expression studies. Sanguine’s temperature-controlled logistics and same-day delivery deliver specimens within hours of phlebotomy.

Sample Annotation: The Often-Overlooked Quality Dimension

High-quality genomic annotation transforms biospecimens from anonymous materials into powerful, reproducible research tools. Physician-confirmed diagnoses provide confidence in disease classification, while detailed medication histories let researchers account for therapeutic interventions that influence immune profiles.[13] Demographic information — age, sex, ethnicity, BMI — enables stratification and investigation of population-specific mechanisms.

Electronic medical record (EMR) integration enables access to longitudinal clinical data including laboratory values, imaging, treatment responses, and disease progression markers. This depth is especially valuable in oncology biospecimens, where tumor stage, histological subtype, and treatment history profoundly influence immune cell phenotypes.[14] Patient-reported outcomes (PRO) data add another dimension, capturing symptom burden, quality of life, and treatment adherence often absent from medical records.

Infectious disease status documentation extends beyond serology to include viral load, CD4+ counts (for HIV studies), vaccination history, and pathogen exposure timelines.[15] This comprehensive annotation distinguishes providers who simply collect samples from those who deliver complete research solutions. Sanguine’s direct-to-donor model across the United States enables access to detailed medical histories and patient-reported data, supporting sophisticated multi-variable analyses.

Critical Quality Metrics Checklist for Immune Cell Biospecimens

Pre-Acquisition Assessment Criteria

When evaluating potential biospecimen sources, systematic assessment of provider capabilities ensures alignment between sample quality and experimental requirements. The following are minimum quality standards for translational research.

Cellular Product Quality Standards:

• Post-thaw viability ≥85% by trypan blue or flow cytometry (7-AAD/PI exclusion)
• Functional viability confirmed by antigen-specific stimulation assays
• Phenotypic stability verified by flow cytometry across major immune subsets
• TNC counts documented with coefficient of variation data
• RBC contamination <5% for enriched products
• Sterility testing completed (negative bacterial/fungal cultures)
• Mycoplasma screening performed (negative by PCR)
• Endotoxin quantification <0.5 EU/mL for sensitive applications
• Cryopreservation medium composition disclosed
• Processing time from collection to preservation documented

Biofluid Quality Standards:

• Hemolysis index <0.5 g/L free hemoglobin
• Lipemia assessment and documentation
• Icterus evaluation when relevant
• Centrifugation protocol specified (g-force, duration, temperature)
• Processing time from venipuncture documented
• Anticoagulant type clearly identified
• Freeze-thaw cycle history tracked
• Storage temperature verification
• Aliquot volume and concentration specified
• Platelet count for plasma specimens

Genomic Annotation Requirements:

• Physician-confirmed diagnosis with ICD-10 codes
• Disease duration and stage classification
• Current medication list with dosages
• Vaccination history (recent 6 months minimum)
• Comorbidity documentation
• Infectious disease serological status
• Demographic data (age, sex, ethnicity, BMI)
• Relevant laboratory values (CBC, chemistry panel)
• Smoking status and substance use history
• Family history for genetic conditions

Post-Acquisition Verification Protocols

On receipt, systematic quality verification protects research investments and ensures validity. Even specimens from qualified providers benefit from third-party validation before labor-intensive or costly downstream applications.

Immediate Assessment (Within 24 Hours):

• Visual inspection for particulate matter or discoloration
• Verify specimen labeling matches documentation
• Confirm storage temperature during transit
• Assess packaging integrity and documentation completeness
• Perform initial cell count and viability assessment
• Document receipt condition with timestamped photographs
• Aliquot samples for quality control testing before main experiment
• Test one aliquot before processing entire batch

Functional Validation:

• Thaw and culture aliquot for 24–48 hours
• Assess proliferation capacity under stimulation
• Verify cytokine production by ELISA or multiplex immunoassay
• Confirm cell surface marker expression by flow cytometry
• Test in pilot functional assay representing main experiment
• Document baseline activation state markers (CD69, CD25, HLA-DR)
• Assess cell morphology by microscopy
• Compare to positive control (matched healthy donor specimen)

Documentation and Traceability:

• Maintain complete chain-of-custody records
• Document all quality control assessment results
• Record storage locations and conditions
• Track freeze-thaw cycles if applicable
• Photograph specimen appearance at key timepoints
• Maintain electronic laboratory notebook entries
• Archive representative aliquots for future validation
• Retain vendor certificates of analysis

Emerging Quality Metrics in Single-Cell and Spatial Technologies

The rapid adoption of single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics has introduced new quality requirements beyond traditional viability metrics. Cell membrane integrity becomes paramount, since compromised membranes lead to ambient RNA contamination and artifactual gene expression signatures.[16] The percentage of mitochondrial reads in scRNA-seq datasets is a sensitive indicator of cellular stress or membrane damage, with healthy samples typically showing <10% mitochondrial content.

Nuclear integrity grows increasingly important for single-nucleus RNA sequencing (snRNA-seq). Nuclear isolation from frozen biospecimens requires careful optimization to prevent fragmentation while minimizing cytoplasmic contamination.[17] For Human Skin Punch Biopsy specimens intended for spatial transcriptomics, tissue architecture preservation and RNA quality (RIN scores ≥7) are critical for high-resolution mapping.

Doublet rates in single-cell preparations significantly affect data quality and analytical complexity. Optimal single-cell suspensions show doublet rates below 5%, though this varies by cell type and methodology.[18] Validating single-cell suspension quality through pilot runs before committing precious biospecimens to expensive sequencing is a prudent strategy. Sanguine’s custom processing can optimize cell isolation for specific single-cell applications, minimizing technical artifacts.

Quality Economics: The True Cost of Suboptimal Biospecimens

The financial implications of poor quality extend far beyond procurement cost. Failed experiments from low-viability or functionally compromised specimens waste expensive reagents, consume personnel time, and delay timelines.[19] For a $500 PBMC sample requiring $5,000 in reagents, $2,000 in labor, and 3 weeks of experimental time, the true cost of a failed experiment approaches $7,500 — fifteen times the specimen cost.

This quality-cost relationship is even more pronounced in clinical development, where failed manufacturing runs or invalidated trial specimens carry six- or seven-figure consequences. Using GMP Leukopak starting material that meets comprehensive specifications reduces process development risk and supports regulatory filing success.[20] The incremental cost of premium-quality biospecimens is often less than 5% of total project costs while dramatically reducing technical risk.

Reproducibility-crisis concerns have intensified scrutiny of specimen quality as a confounding variable. Publications increasingly require detailed provenance documentation — collection methods, processing protocols, storage conditions, and QC data.[21] Researchers who establish rigorous quality standards from project inception protect themselves from future reproducibility challenges and enhance translational relevance.

Sanguine’s Quality Assurance Framework

Our comprehensive quality management system spans every phase of the biospecimen lifecycle, from donor recruitment through delivery. Direct relationships with over 70,000 donors across the United States enable access to diverse patient populations while maintaining consistent standards.[22] Every specimen undergoes multi-parameter QC testing, with results documented in certificates of analysis accompanying each shipment.

Standardized processing ensures lot-to-lot consistency whether researchers order Human Whole Blood, Human Plasma, or isolated cellular products. Temperature-controlled logistics maintain cold-chain integrity from collection through delivery, with real-time tracking. Custom collection services accommodate study-specific requirements, from non-standard anticoagulants to specialized processing.

Comprehensive genomic annotation elevates biospecimen utility beyond simple material provision. Physician-confirmed diagnoses, detailed medication histories, and patient-reported outcomes transform anonymous samples into phenotypically rich resources.[23] This depth is particularly valuable for infectious disease biospecimens, where pathogen exposure history, vaccination status, and treatment regimens significantly influence immune cell phenotypes.

From study design to receipt of samples, our team collaborates with researchers to identify optimal collection strategies, processing protocols, and QC parameters. This consultative approach has supported over 500 research programs across academic institutions, pharmaceutical companies, and biotechnology firms.

Best Practices for Quality-Focused Biospecimen Procurement

Strategic Vendor Selection Criteria

Identifying providers who prioritize quality over volume requires systematic evaluation across multiple dimensions. Price per sample should never be the sole criterion — the total cost of ownership, including failed experiments, repeated assays, and delays, often makes premium-quality specimens the most economical choice.

Essential Provider Capabilities:

• ISO certification demonstrating quality management systems (ISO 9001:2015, ISO 13485:2016)
• Documented standard operating procedures for all collection and processing steps
• Third-party validation of viability and functional metrics
• Transparent disclosure of processing timelines and conditions
• Comprehensive certificates of analysis with each shipment
• Direct-to-donor model enabling detailed medical history access
• Flexible custom collection capabilities for study-specific requirements
• Regulatory compliance documentation (IRB, HIPAA, 21 CFR Part 11)
• Temperature-controlled logistics with real-time tracking
• Scientific support team with immunology expertise
• Published validation data and customer testimonials
• Lot-to-lot consistency demonstrated across multiple shipments

Red Flags in Biospecimen Procurement:

• Vague or missing quality control data
• Inability to provide processing timelines
• Generic “De-identified Donor Data” without specific fields
• No physician confirmation of diagnoses
• Unclear specimen provenance
• Absence of regulatory compliance documentation
• Poor communication or scientific support
• Extremely low pricing suggesting quality compromises
• No validation data available
• High minimum order quantities forcing overbuy
• Inflexible processing protocols
• Limited annotation depth

Matching Sample Quality to Research Applications

Different applications demand different quality thresholds. Over-specification unnecessarily increases costs; under-specification risks failure. Flow cytometry immunophenotyping tolerates lower viability (≥75%) than adoptive transfer studies requiring ≥90% viable cells.[24] Understanding application-specific requirements lets researchers optimize quality-cost tradeoffs strategically.

Basic mechanistic studies using established protocols may use standard-quality biospecimens with conventional metrics. Clinical biomarker validation targeting regulatory submissions requires enhanced documentation, including donor identity protection, full informed consent, and comprehensive compliance records.[25] Therapeutic development falls between these extremes, requiring functional validation but not necessarily full GMP compliance until clinical manufacturing.

“Fitness for purpose” should guide selection. A high-throughput drug screen testing thousands of compounds may prioritize cost and availability, accepting 75–80% viability if cell numbers remain sufficient. Conversely, manufacturing patient-specific CAR-T products for early-phase trials demands ≥95% viable cells with documented sterility and comprehensive QC at every step.[26] Matching specimen quality to application requirements optimizes both scientific outcomes and budgets.

Geographic and Demographic Diversity in Quality Assessment

Population diversity is an often-overlooked quality dimension. Immune cell phenotypes, frequencies, and functional capacities vary significantly across demographic groups due to genetic background, environmental exposures, and comorbidity patterns.[27] Research conducted only on limited demographic groups may generate findings with reduced generalizability or miss population-specific therapeutic opportunities.

Sanguine’s donor network spans the United States, enabling access to demographically diverse populations including underrepresented ethnic groups, rural communities, and patients with complex comorbidities. This breadth supports health equity research and enhances translational relevance. For oncology biospecimens, access to diverse cancer patient populations enables investigation of ethnic disparities in treatment response and survival.

Quality assessment protocols should include demographic representation verification, ensuring experimental cohorts match target population characteristics. This is particularly critical for biomarker validation where population-specific calibration may affect diagnostic thresholds.[28] Our comprehensive demographic documentation enables stratified analyses and supports regulatory submissions requiring diversity demonstration.

The Future of Biospecimen Quality Standards

Emerging technologies and evolving regulations continue to raise quality expectations. Multi-omic integration studies combining transcriptomics, proteomics, metabolomics, and epigenomics demand unprecedented quality, since artificial variation from poor handling can overwhelm true biological signals.[29] Advanced therapies like CAR-T require starting materials meeting pharmaceutical-grade specifications with full batch traceability.

Artificial intelligence and machine learning applications amplify the importance of specimen quality, since algorithms trained on artifact-contaminated data may learn patterns representing technical noise rather than biology.[30] Quality-focused procurement is an essential first step in ensuring AI-driven discoveries reflect genuine biology rather than processing confounders.

The regulatory landscape continues evolving, with increasing emphasis on ethical sourcing, informed consent documentation, and data privacy. Providers demonstrating proactive compliance position their customers for success. Sanguine’s commitment to ethical sourcing, comprehensive consent, and robust data protection keeps research programs compliant with current and anticipated requirements.

---

Check Our Inventory

Ready to elevate your research with premium-quality immune cell biospecimens?

Explore our comprehensive inventory of oncology biospecimens and infectious disease biospecimens today. Our scientific specialists can discuss your specific requirements and recommend optimal biospecimen solutions.

Request a Custom Quote →

---

Ethical Sourcing and Regulatory Compliance

All Sanguine biospecimens are collected under IRB-approved protocols with comprehensive informed consent from every donor. Our HIPAA-compliant data management systems protect donor privacy while enabling researchers to access detailed genomic annotation supporting their studies. We maintain ISO 9001:2015 and ISO 13485:2016 certifications demonstrating our commitment to quality management across all operations.

Donor compensation follows ethical guidelines established by professional societies, ensuring voluntary participation without coercion. Geographic diversity in our collection network across the United States supports health equity in research while providing access to underrepresented populations often excluded from biomedical studies. Every specimen is designated Research Use Only (RUO) with clear documentation of its intended application scope.

---

References

1. Ramachandran H, Laux J, Moldovan I, et al. Optimal thawing of cryopreserved peripheral blood mononuclear cells for use in high-throughput human immune monitoring studies. Cells. 2012;1(3):313-324. doi:10.3390/cells1030313
2. Engel P, Boumsell L, Balderas R, et al. CD nomenclature 2015: Human leukocyte differentiation antigen workshops as a driving force in immunology. J Immunol. 2015;195(10):4555-4563. doi:10.4049/jimmunol.1502033
3. Chiu YL, Shan L, Huang H, et al. Sprouty2 regulates HIV replication independent of blocking Ras activation. J Immunol. 2014;192(9):4291-4300. doi:10.4049/jimmunol.1302709
4. Maecker HT, McCoy JP, Nussenblatt R. Standardizing immunophenotyping for the Human Immunology Project. Nat Rev Immunol. 2012;12(3):191-200. doi:10.1038/nri3158
5. Stroncek DF, Fellowes V, Pham C, et al. Counter-flow elutriation of clinical peripheral blood mononuclear cell concentrates for the production of dendritic and T cell therapies. J Transl Med. 2004;2:23. doi:10.1186/1479-5876-2-23
6. Lee JA, Spidlen J, Boyce K, et al. MIFlowCyt: the minimum information about a flow cytometry experiment. Cytometry A. 2008;73(10):926-930. doi:10.1002/cyto.a.20623
7. Simaria AS, Hassan S, Varadaraju H, et al. Allogeneic cell therapy bioprocess economics and optimization: Single-use cell expansion technologies. Biotechnol Bioeng. 2014;111(1):69-83. doi:10.1002/bit.25008
8. Drake SK, Bowen RA, Remaley AT, Hortin GL. Potential interferences from blood collection tubes in mass spectrometric analyses of serum polypeptides. Clin Chem. 2004;50(12):2398-2401. doi:10.1373/clinchem.2004.040303
9. Tuck MK, Chan DW, Chia D, et al. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009;8(1):113-117. doi:10.1021/pr800545q
10. Betsou F, Lehmann S, Ashton G, et al. Standard preanalytical coding for biospecimens: defining the sample PREanalytical code. Cancer Epidemiol Biomarkers Prev. 2010;19(4):1004-1011. doi:10.1158/1055-9965.EPI-09-1268
11. Lippi G, Salvagno GL, Montagnana M, Lima-Oliveira G, Guidi GC, Favaloro EJ. Quality standards for sample collection in coagulation testing. Semin Thromb Hemost. 2012;38(6):565-575. doi:10.1055/s-0032-1315961
12. Debey-Pascher S, Eggle D, Schultze JL. RNA stabilization of peripheral blood and profiling by bead chip analysis. Methods Mol Biol. 2009;496:175-210. doi:10.1007/978-1-59745-553-4_13
13. Vaught J, Rogers J, Carolin T, Compton C. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue biobank. J Natl Cancer Inst Monogr. 2011;2011(42):24-31. doi:10.1093/jncimonographs/lgr009
14. Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132(12):1929-1935. doi:10.5858/132.12.1929
15. Moore HM, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol. 2011;119(2):92-101. doi:10.1002/cncy.20147
16. Ilicic T, Kim JK, Kolodziejczyk AA, et al. Classification of low quality cells from single-cell RNA-seq data. Genome Biol. 2016;17:29. doi:10.1186/s13059-016-0888-1
17. Bakken TE, Hodge RD, Miller JA, et al. Single-nucleus and single-cell transcriptomes compared in matched cortical cell types. PLoS One. 2018;13(12):e0209648. doi:10.1371/journal.pone.0209648
18. Wolock SL, Lopez R, Klein AM. Scrublet: computational identification of cell doublets in single-cell transcriptomic data. Cell Syst. 2019;8(4):281-291.e9. doi:10.1016/j.cels.2018.11.005
19. Freedman LP, Cockburn IM, Simcoe TS. The economics of reproducibility in preclinical research. PLoS Biol. 2015;13(6):e1002165. doi:10.1371/journal.pbio.1002165
20. Levine BL, Miskin J, Wonnacott K, Keir C. Global manufacturing of CAR T cell therapy. Mol Ther Methods Clin Dev. 2017;4:92-101. doi:10.1016/j.omtm.2016.12.006
21. Freedman LP, Venugopalan G, Wisman R. Reproducibility2020: Progress and priorities. F1000Res. 2017;6:604. doi:10.12688/f1000research.11334.1
22. Henderson GE, Cadigan RJ, Edwards TP, et al. Characterizing biobank organizations in the US: results from a national survey. Genome Med. 2013;5(1):3. doi:10.1186/gm407
23. Bledsoe MJ, Grizzle WE. Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape. Diagn Histopathol. 2013;19(9):322-330. doi:10.1016/j.mpdhp.2013.06.011
24. Berglund S, Magalhaes I, Gaballa A, et al. Advances in umbilical cord blood cell therapy: the present and the future. Expert Opin Biol Ther. 2017;17(6):691-699. doi:10.1080/14712598.2017.1316713
25. Coppola L, Cianflone A, Grimaldi AM, et al. Biobanking in health care: evolution and future directions. J Transl Med. 2019;17(1):172. doi:10.1186/s12967-019-1922-3
26. Vormittag P, Gunn R, Ghorashian S, Veraitch FS. A guide to manufacturing CAR T cell therapies. Curr Opin Biotechnol. 2018;53:164-181. doi:10.1016/j.copbio.2018.01.025
27. Nédélec Y, Sanz J, Baharian G, et al. Genetic ancestry and natural selection drive population differences in immune responses to pathogens. Cell. 2016;167(3):657-669.e21. doi:10.1016/j.cell.2016.09.025
28. Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst. 2008;100(20):1432-1438. doi:10.1093/jnci/djn326
29. Hasin Y, Seldin M, Lusis A. Multi-omics approaches to disease. Genome Biol. 2017;18(1):83. doi:10.1186/s13059-017-1215-1
30. Rajkomar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347-1358. doi:10.1056/NEJMra1814259