Healthy Bulk Plasma

Healthy Bulk Plasma Collected via Apheresis in ACDA for Assay Development and Bioprocessing

Healthy Bulk Plasma is collected from IRB-consented healthy adult donors using apheresis and anticoagulated with Acid-Citrate-Dextrose Formula A (ACDA). Apheresis yields large plasma volumes with consistent quality and composition from a single donor, making this product suited to bioprocessing, diagnostic assay development, protein purification, and use as a normal control matrix in studies where a disease-state comparator is being characterised.

Why Apheresis Bulk Plasma in ACDA

  • Apheresis produces far larger volumes from one donor than a standard venipuncture. A whole assay validation or purification campaign can therefore run on a single donor lot, eliminating the lot-to-lot and donor-to-donor variability that limits pooled small-draw material.
  • ACDA is a citrate-based anticoagulant. Citrate chelates calcium reversibly, so calcium can be restored by recalcification for downstream assays that depend on divalent cations — an advantage over EDTA, whose chelation is far harder to reverse and which inhibits many metalloenzymes outright.
  • Citrate anticoagulation is the standard for apheresis because it preserves cellular integrity during extracorporeal processing, which in turn limits the release of intracellular contents into the plasma fraction.
  • Plasma is separated without a clotting step, so fibrinogen, coagulation factors and complement components remain intact rather than being consumed. This matters for protein purification and for any application requiring an unactivated coagulation system.
  • Plasma from healthy donors is the natural normal matrix for diagnostic assay development: spike-and-recovery, linearity, interference testing, calibrator diluent preparation and negative control material all require well-characterised non-diseased plasma.
  • As a baseline comparator, healthy bulk plasma allows disease-state plasma results to be interpreted against a normal reference generated on the same platform and in the same matrix.

Donor Stratification Available

  • Age range and age-banded cohorts
  • Sex assigned at birth
  • Race and ethnicity
  • BMI range where reported
  • Repeat or serial collections from the same donor for longitudinal and single-source studies
  • Infectious disease screening results, confirmed negative for HIV, HBV and HCV
  • This product serves as the matched healthy control for disease-state plasma across our catalogue; matched case-control cohorts can be arranged on request

Product Features

  • Collected via apheresis for high-volume yield
  • Anticoagulated using ACDA (Acid-Citrate-Dextrose Formula A)
  • Tested and confirmed negative for HIV, HBV, and HCV
  • IRB-approved donor consent and HIPAA-compliant data handling
  • Available fresh with custom volumes upon request
  • Single-donor lots available to avoid pooling variability

De-identified Donor Data

  • IRB-consented healthy adult donors
  • Demographics: age, sex assigned at birth, race/ethnicity
  • Screened for infectious disease markers
  • Donor-reported medication history where available

Applications

  • Biomanufacturing and bioprocess development
  • Serological and immunoassay development
  • Normal control matrix for diagnostic assay validation, including spike-recovery and linearity testing
  • Calibrator and control diluent preparation
  • Protein purification, including immunoglobulins, albumin and complement components
  • Coagulation factor and complement pathway research
  • Baseline comparator for disease-state plasma studies
  • Biomarker discovery reference material and platform benchmarking

Other Healthy Donor Specimen Types

Compliance and Quality Assurance

  • Screened for HIV, HBV, and HCV
  • Collected under IRB-approved protocols
  • 21 CFR Part 11-compliant informed consent
  • HIPAA-compliant donor data privacy

Ordering & Customization

Healthy Bulk Plasma is available in standard and custom volumes. For pricing, availability, regulatory documentation, infectious disease reports, or international shipping details, contact learnmore@sanguinebio.com. To browse plasma across all disease states and healthy donors, 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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