Crohn’s Disease Bulk Plasma

Crohn’s Disease Bulk Plasma for Immune-Mediated Inflammatory Bowel Disease Research

Crohn’s Disease Bulk Plasma is collected from IRB-consented donors diagnosed with Crohn’s disease using apheresis with ACDA (Acid-Citrate-Dextrose Formula A) as the anticoagulant. Apheresis collection yields far more plasma per donor than a standard venous draw, which is what makes single-donor bulk lots practical for assay development, reagent qualification and screening campaigns that would otherwise consume many small aliquots. Crohn’s disease is an immune-mediated inflammatory bowel disease driven by a dysregulated mucosal immune response to the gut microbiota in genetically susceptible individuals, not by a classical autoantibody response.

Why High-Volume Crohn’s Disease Plasma

  • Single-donor bulk volume removes lot-to-lot donor variability from long assay development campaigns, so a Crohn’s-positive control matrix can stay constant from feasibility through validation.
  • Crohn’s inflammation runs through the IL-12/IL-23, Th1/Th17 and TNF axis. Large volumes support the repeated dilution series, spike-recovery and linearity work needed to qualify multiplex cytokine panels in a disease-state matrix.
  • ACDA is a citrate-dextrose anticoagulant; citrate chelates calcium and preserves complement and coagulation-sensitive analytes that are consumed when blood is allowed to clot for serum.
  • Anti-Saccharomyces cerevisiae antibodies (ASCA) are common in Crohn’s disease and are antibodies to a microbial antigen rather than autoantibodies. Bulk lots supply enough material to develop and validate ASCA and other IBD serology assays against a consistent positive matrix.
  • High-volume plasma also supports depletion, fractionation and affinity enrichment workflows, and isolation of extracellular vesicles or cell-free DNA, all of which consume input volume quickly.
  • Bulk lots are useful as disease-state reference and calibration material for therapeutic drug monitoring assays covering anti-TNF, anti-IL-23 and anti-integrin biologics.

Donor Stratification Available

  • Disease activity, including clinical remission versus active flare, with Harvey-Bradshaw Index or CDAI where documented
  • Montreal classification: age at diagnosis, disease location (ileal, colonic, ileocolonic, upper GI) and behaviour (non-stricturing, stricturing, penetrating)
  • Serology and laboratory results where available, including ASCA status, CRP and faecal calprotectin
  • Treatment status: biologic-naive, anti-TNF, anti-IL-12/23 or anti-IL-23, anti-integrin, JAK inhibitor, corticosteroid or immunomodulator
  • Surgical and complication history, including prior resection and perianal fistulising disease
  • Matched healthy controls available, as well as ulcerative colitis donors for IBD subtype comparison

Product Features

  • High-volume plasma collected via apheresis
  • Anticoagulated using ACDA (Acid-Citrate-Dextrose Formula A)
  • Tested and confirmed negative for HIV, HBV, and HCV
  • Available fresh, with custom volumes upon request; volumes reported per lot
  • Single-donor lots for consistency across long assay campaigns
  • IRB-approved informed consent and HIPAA-compliant handling

De-identified Donor Data

  • Clinically confirmed diagnosis of Crohn’s disease
  • Donor demographics: age, sex assigned at birth, race/ethnicity
  • Clinical history and medication data available
  • Additional Crohn’s disease-specific metadata available on request

Applications

  • Immunoassay development, spike-recovery and linearity work in a disease-state matrix
  • Disease-state positive control and calibration material for kit qualification
  • Cytokine and inflammatory mediator profiling across the TNF and IL-23/Th17 axes
  • ASCA and IBD serology assay development
  • Plasma proteomic and metabolomic discovery requiring large input volumes
  • Extracellular vesicle and cell-free DNA isolation
  • Depletion, fractionation and affinity enrichment workflows
  • Therapeutic drug monitoring and anti-drug antibody assay development

Other Crohn’s Disease Specimen Types

Compliance and Quality Assurance

  • Screened negative for HIV, HBV, and HCV
  • IRB-approved collection with 21 CFR Part 11-compliant consent
  • Standardized apheresis collection and processing protocols
  • HIPAA-compliant donor data protection

Ordering & Customization

Crohn’s Disease Bulk Plasma is available in standard or custom volumes. For pricing, current availability, or a quote on a stratified donor cohort, email learnmore@sanguinebio.com. For documentation or international shipping, please contact us to confirm regional compliance. To browse other disease states in this specimen type, visit our human plasma page.

Frequently Asked Questions

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Are samples IRB approved?

1 Answer

YES – All collections are conducted under IRB-approved protocols and electronic informed consent. Sanguine utilizes Advarra and WCG IRB for oversight.

YES – all our products are research use only (RUO).

Storage depends on sample type but often cryopreserved samples stored in liquid nitrogen can be stored for years.

Extensive customization is available. To discuss your project request a quote or email us at learnmore@sanguinebio.com.

Sanguine offers flexible prospective collection services tailored to fit your research. For more information and to request a quote, please see: our prospective biospecimen collection services page.

Timelines depend on condition, sample type, and I/E criteria but we often start collection within 2 weeks of signed agreement.

YES – we have in-stock inventory. You can also email us at learnmore@sanguinebio.com as we continually get new samples in our inventory.

Each sample from a different individual – Unique donor means each sample comes from a different person, ensuring biological diversity in your study.

YES – Unique donors can be specified and guaranteed based on your requirements.

For information about sample quality, please see: Quality and Compliance

YES – “IRB-approved collection protocols” and IRB approval documentation available upon request. Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval.

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Need a custom Bulk Plasma cohort?

Our scientific team can scope prospective collections with donor-specific I/E criteria, typically starting within 2 weeks of agreement.

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