Healthy Bulk Plasma

About 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

• Healthy Plasma
• Healthy PBMC
• Healthy Pediatrics PBMC
• Human Bulk Plasma

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.