Description
Cryopreserved leukopaks from disease-state donors, currently focused on systemic lupus erythematosus (SLE) with active expansion into Crohn’s disease, ulcerative colitis, celiac disease, rheumatoid arthritis, and multiple sclerosis as donor sourcing comes online. Each unit delivers a full leukopak (10 billion or more cells) from a single donor, screened against 14 infectious disease markers under 21 CFR 1271, with high-resolution NGS HLA typing across HLA-A, B, C, DR, DQ, and DP. Best fit: biomarker discovery, autoimmune drug screening, and cell therapy programs requiring disease-relevant immune dysregulation in vitro.
Frozen Leukopak (Disease State)
Cryopreserved disease-state leukopaks for autoimmune research, cell therapy development, and disease-mechanism studies. Available SKUs cover SLE/Lupus donors, with additional autoimmune conditions added on request.
Key Applications
- Autoimmune disease research (lupus, IBD, RA, MS, celiac)
- Disease-state vs. healthy donor comparability studies
- Cell therapy development for autoimmune conditions
- Functional immune cell profiling in disease
Collected under IRB-approved protocols with disease-state donor screening. documentation included with every lot.
Frequently Asked Questions
What disease states are available in OrganaBio frozen leukopaks?
OrganaBio currently offers disease-state frozen leukopaks from SLE/Lupus donors (LKP-SLE-008). Active expansion is in progress for Crohn’s disease, ulcerative colitis, celiac disease, rheumatoid arthritis, and multiple sclerosis as donor recruitment comes online.
How are disease-state donors screened?
All disease-state donors are screened against 14 infectious disease markers per 21 CFR 1271 (HIV-1/2, hepatitis B/C, HTLV-I/II, West Nile, Chagas) plus CMV, EBV, and alloantibodies. Disease-state confirmation is by clinical diagnosis. NGS HLA typing across HLA-A, B, C, DR, DQ, DP is provided per donor.
What cell counts should I expect from a disease-state leukopak?
Each full disease-state leukopak delivers a minimum of 10 billion cells from a single donor, sourced from OrganaBio’s qualified, recallable donor pool.
Are disease-state leukopaks available at clinical grade?
Yes. OrganaBio’s disease-state donors serve both RUO and cGMP grades under one quality system. Programs moving from biomarker discovery to clinical material do not requalify donors.
Can I request specific donor characteristics for disease-state collections?
Yes. Donor characteristics tracked and customer-selectable include gender, age, race, ethnicity, blood type, BMI, smoking status, and CMV/EBV status.
Ordering information
Scope disease-state frozen leukopaks for your program
Use this route when a program needs a whole cryopreserved leukopak from a disease-state donor for autoimmune research, biomarker discovery, or disease-mechanism studies.
| Source and format | Cryopreserved whole leukopaks from disease-state donors, currently focused on SLE/Lupus with additional indications added as donor sourcing comes online. |
|---|---|
| Published specifications | Each full disease-state leukopak is documented at a minimum of 10 billion cells from one donor. Donors are screened against 14 infectious-disease markers under 21 CFR 1271, with high-resolution NGS HLA typing across HLA-A, B, C, DR, DQ, and DP. |
| Availability | Product-specific lot status, donor criteria, quantity, grade, documentation, and timing are confirmed with the OrganaBio scientific team. |
| Documentation | The current record describes IRB-approved protocols, disease-state donor screening, and documentation included with every lot. |
| Storage and shipping | This is a cryopreserved whole-leukopak format; product-specific storage, shipment, and handling details are confirmed for the requested lot. |
| Intended use and grade | The current record documents both RUO and cGMP grades for disease-state donors; confirm the grade and intended use for the requested lot. |
