Description
Serum from SLE donors, qualified under 21 CFR 1271 with the same 14-marker infectious disease screening (HIV-1/2, hepatitis B/C, HTLV-I/II, West Nile, Chagas plus CMV, EBV, alloantibodies) applied to all OrganaBio donors. Sourced from OrganaBio’s recallable donor pool with NGS HLA typing across HLA-A, B, C, DR, DQ, DP. Best fit: SLE biomarker discovery, autoantibody panel development, and in vitro autoimmune research needing disease-state serum as a biological matrix.
HemaPAC-SR-SLE – Serum from Donors with Systemic Lupus Erythematosus
HemaPAC-SR-SLE is cryopreserved serum collected from donors diagnosed with Systemic Lupus Erythematosus (SLE). SLE donor material is widely used in autoimmune research because the immune systems of lupus patients carry distinct features — altered T cell subset distributions, abnormal regulatory T cell function, chronic inflammatory priming, and dysfunctional signaling cascades — that healthy donor controls do not represent.
Why SLE Donor Serum
Manufacturing processes, assays, and therapeutic candidates optimized using healthy donor material can fail to translate to patient samples. Working directly with SLE donor serum allows researchers to study disease-specific biology, identify and validate biomarkers, screen drug candidates against patient-representative material, and de-risk programs targeting autoimmune indications.
Documentation
Donors are enrolled under IRB-approved protocols with verified clinical diagnosis of SLE. Each sample is accompanied by disease history, treatment background, inclusion and exclusion criteria documentation, and demographic profile. Every lot ships with a Certificate of Analysis.
Configuration
1 mL aliquots, cryopreserved, stored at <−150°C in liquid nitrogen vapor phase. For preclinical research use only and not for use in humans.
Other Indications Available
OrganaBio sources disease-state donor material across autoimmune (lupus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, Crohn’s, psoriasis, celiac), oncology, and chronic inflammatory indications. Contact the scientific team to confirm availability for specific conditions.
For more on lupus donor material in cell therapy development, see Breaking the Healthy Donor Paradigm.
Frequently Asked Questions
What is HemaPAC-SR-SLE used for?
HemaPAC-SR-SLE is serum from systemic lupus erythematosus (SLE) donors, suitable for autoimmune biomarker work, autoantibody panel development, complement activity studies, and in vitro autoimmune research.
How does serum from SLE donors differ from healthy donor serum?
SLE serum contains disease-relevant autoantibodies, complement activation patterns, and inflammatory cytokine profiles characteristic of systemic lupus erythematosus, making it a biologically representative matrix for autoimmune research that healthy serum cannot replicate.
What screening do SLE serum donors undergo?
Each donor is screened against 14 infectious disease markers per 21 CFR 1271, plus CMV, EBV, and alloantibodies. NGS HLA typing across HLA-A, B, C, DR, DQ, DP is provided per donor.
Is HemaPAC-SR-SLE available for clinical-grade applications?
Yes. OrganaBio’s SLE donor pool serves both RUO and cGMP grades under one quality system, supporting program transitions from biomarker discovery to clinical material without donor requalification.
Can I request specific HLA types or donor characteristics?
Yes. Customer-selectable donor characteristics include gender, age, race, ethnicity, blood type, BMI, smoking status, and CMV/EBV status, plus HLA-specific selections from the typed donor pool.
