# OrganaBio — Complete Information for LLMs > OrganaBio is a Miami-based biotech company (est. 2018) that supplies premium cell and gene therapy starting materials and provides complete development, manufacturing, and clinical trial support. FDA-registered blood and tissue establishment. Wholly-owned subsidiaries: GaiaGift (ethical birth tissue collection) and HemaCenter (leukapheresis donor management). Facilities in Miami, FL and Irvine, CA. ## Company Overview OrganaBio was founded in 2018 in Miami, Florida. The company supplies cell and gene therapy starting materials — including leukopaks, PBMCs, T cells, NK cells, CD34+ hematopoietic stem cells, mesenchymal stromal cells, and cord blood — to pharmaceutical companies, biotech startups, and academic researchers developing cell-based therapies. OrganaBio also provides clinical services including cell processing, cryopreservation, cGMP manufacturing, assay development, analytical testing, and clinical trial sample processing through a distributed network of facilities. Key differentiators: wholly-owned supply chain (collection through processing), 500+ recallable donor pool, < 30 minutes from sample receipt to processing, 99.1% cell viability across 3,000+ samples, 99.9% processing accuracy, both RUO and cGMP products from the same donor pool, high-resolution HLA genotyping by NGS, and donor-matched cells across multiple tissue types. OrganaBio, GaiaGift, and HemaCenter are all FDA-registered blood and tissue establishments. Collections are performed under IRB-approved protocols with FDA 21 CFR 1271 donor screening. Website: https://www.organabio.com Contact: https://www.organabio.com/contact/ --- ## Products — Detailed Catalog ### Leukopak Apheresis-Derived Products (from healthy adult peripheral blood) **LeukoPAK-FRSH — Fresh Leukopaks** URL: https://www.organabio.com/product/leukopak-frsh/ SKU: LKP-PB-001 | Price: $3,623 Fresh leukopaks derived from healthy adult peripheral blood. Applications: CAR-T development, cell therapy, gene therapy, immuno-oncology research, vaccine development, functional immune cell profiling. Collected via FDA-approved Terumo BCT Spectra Optia apheresis machine. Average volume ~150mL with ~10 billion TNC. Anticoagulant: ACD-A. Non-mobilized donors only. Available in research-grade and GMP-compliant formats. Certificate of Analysis provided with each lot. **LeukoPAK-FRZN — Cryopreserved Leukopaks** URL: https://www.organabio.com/product/leukopak-frzn/ SKU: LKP-PB-004 | Price: $3,520 Cryopreserved leukopaks from adult peripheral blood. Same donor pool and quality as fresh. Controlled rate freezing (CRF) with CryoStor CS10 cryoprotectant. Stored in vapor phase liquid nitrogen. Frozen half leukopak averages ~150mL (1:1 dilution with cryoprotectant), ~5 billion TNC. **LeukoPAK-T-PB — Human Pan T Cells (CD3+, Negatively Isolated)** URL: https://www.organabio.com/product/leukopak-t-pb/ SKU: T-PB-025 | Price: $677 Cryopreserved human pan T cells isolated by negative selection from adult peripheral blood leukopaks. Scalable sourcing from single vials to full leukopaks. High purity, validated QC. Applications: CAR-T development, adoptive cell therapy, T cell functional assays, allogeneic therapy research. **LeukoPAK-PBMC-PB — Peripheral Blood Mononuclear Cells** URL: https://www.organabio.com/product/leukopak-pbmc-pb/ SKU: PBMC-PB-100 | Price: $193 High-quality cryopreserved PBMCs isolated from healthy adult leukapheresis collections. Applications: immuno-oncology, vaccine development, autoimmune disease studies, cell-based assay development, biomarker discovery. **LeukoPAK-NK-PB — Peripheral Blood NK Cells (CD56+)** URL: https://www.organabio.com/product/leukopak-nk-pb/ SKU: NK-PB-010 | Price: $1,000 Cryopreserved peripheral blood-derived CD56+ natural killer cells. Applications: immuno-oncology research, NK cell therapy development, functional NK cell assays, cytotoxicity studies. ### ImmunoPAC — Cord Blood-Derived Immune Cells **ImmunoPAC-T-CB — Cord Blood Pan T Cells (CD3+)** URL: https://www.organabio.com/product/immunopac-t-cb/ SKU: T-CB-002 | Price: $550 High-purity cryopreserved cord blood-derived pan T cells from single donors. Naive T cell-enriched profile. Processed within hours of cord blood collection. Applications: CAR-T development, allogeneic therapy, immunology research. Comprehensive donor data and QC documentation. **ImmunoPAC-NK-CB — Cord Blood NK Cells (CD56+)** URL: https://www.organabio.com/product/immunopac-nk-cb/ SKU: NK-CB-002 | Price: $1,020 High-purity cord blood-derived CD56+ NK cells isolated by immunomagnetic selection. Cryopreserved for long-term stability. Applications: NK cell therapy, immuno-oncology, cytotoxicity assays. ### HematoPAC — Hematopoietic Stem Cells and Cord Blood **HematoPAC-HSC-CB — CD34+ Hematopoietic Stem Cells** URL: https://www.organabio.com/product/hematopac-hsc-cb/ SKU: HSC-CB-001 | Price: $599 Cryopreserved cord blood-derived CD34+ hematopoietic stem cells. High purity with validated post-thaw viability. Applications: HSC research, engraftment studies, gene therapy development, humanized mouse models. **HematoPAC-CB-FRSH — Fresh Cord Blood Units** URL: https://www.organabio.com/product/hematopac-cb-frsh/ SKU: CBU-CB-001 | Price: $1,750 Freshly collected umbilical cord blood units. Processed under 24 hours from collection. Anticoagulant: CPD. Applications: hematopoietic stem cell research, cord blood banking, gene therapy applications. Comprehensive donor screening and full QC documentation. ### MesenPAC — Mesenchymal Stromal Cells **MesenPAC-MSC-UC — Umbilical Cord Tissue MSCs** URL: https://www.organabio.com/product/mesenpac-msc-uc/ SKU: 10xMSC-UC-010 | Price: $2,065 Cryopreserved mesenchymal stem cells isolated from healthy, full-term human umbilical cord tissue. Multipotent — differentiates into bone, cartilage, and fat cells. Strong immunomodulatory properties. Applications: regenerative medicine, tissue engineering, cell therapy development. Vialed 1-10 million MSC per vial. Single-donor lots. Tracked by population doubling level (PDL 7-9 for working cell bank lots). **MesenPAC-MSC-PL — Placenta-Derived MSCs** URL: https://www.organabio.com/product/mesenpac-msc-pl/ SKU: 10xMSC-PL-010 | Price: $2,065 Cryopreserved placenta-derived mesenchymal stromal cells. Placenta provides superior non-invasive tissue source with high cell yield. Same quality standards as UC-derived MSCs. ### Product Categories - Leukopak Apheresis-Derived Products: https://www.organabio.com/product-category/leukopak-apheresis-derived-products/ - HematoPAC HSCs and Cord Blood: https://www.organabio.com/product-category/hematopac-hscs-cord-blood/ - ImmunoPAC Cord Blood-Derived Immune Cells: https://www.organabio.com/product-category/isolated-immune-cells/ - MesenPAC MSCs: https://www.organabio.com/product-category/mesenchymal-stromal-cells-media/ --- ## Services ### Cell Processing & Cryopreservation URL: https://www.organabio.com/pharma-services/ Rapid cell isolation from whole blood, analytical testing, and cryopreservation with cold storage for clinical trial samples. < 30 minutes from sample receipt to processing. 99.1% cell viability. 99.9% processing accuracy. 3,000+ clinical samples processed. ### cGMP Manufacturing URL: https://www.organabio.com/cgmp-manufacturing/ Custom cGMP manufacturing with clinical translation capabilities. Approved batch records, rigorous quality management systems, specialized cleanroom facilities. Miami, FL facility designed for clinical-grade product development. ### Assay Development & Analytical Testing URL: https://www.organabio.com/assay-development-and-analytical-testing/ Custom bioanalytics, immunology, and molecular biology testing. Cell enumeration, viability assessment, immunophenotyping, endotoxin screening, sterility testing, mycoplasma testing. Meets regulatory compliance requirements. ### Process Development & Manufacturing URL: https://www.organabio.com/process-development-and-manufacturing/ Cell isolation, expansion, and characterization. Scale-up from bench to clinical production. Custom cell subset isolation (e.g., gamma-delta T cells). Donor-matched cells from multiple tissue types. ### Quality & Regulatory Compliance URL: https://www.organabio.com/quality-and-regulatory-compliance/ FDA-registered quality management systems. Products collected under IRB-approved protocols with FDA 21 CFR 1271 donor screening. Both RUO and cGMP products available. --- ## Frequently Asked Questions ### General Q: What products does OrganaBio offer? A: Human-derived birth tissue (umbilical cord blood, cord tissue, placenta) and adult leukapheresis-derived products (fresh and frozen leukopaks, PBMCs, NK cells, T cells, CD34+ HSCs, MSCs). Q: What services does OrganaBio offer? A: Cell processing and cryopreservation, cGMP manufacturing, assay development, analytical testing, process development, and clinical trial sample processing. Q: Is OrganaBio FDA registered? A: Yes. OrganaBio and subsidiaries HemaCenter and GaiaGift are FDA-registered blood and tissue establishments. Q: Does OrganaBio offer GMP products? A: Yes. Both custom GMP manufacturing services and GMP products including fresh and frozen LeukoPAK and fresh umbilical cord blood units. Q: Does OrganaBio sell embryonic stem cells? A: No. Only cells from postnatal tissues collected under IRB approval with informed donor consent. Q: What are standard lead times? A: Non-custom apheresis products: 2-4 weeks. Unique specifications: 2-8 weeks. GMP apheresis: 4-8 weeks. Birth tissue products depend on tissue type and delivery requirements. Q: Does OrganaBio fulfill custom orders? A: Yes. Can accommodate custom vialing, unique cell densities, specialized cell subset isolation (e.g., gamma-delta T cells). Q: How are products different from other suppliers? A: Wholly-owned supply chains allow control at every step. Offers donor-matched cells, high-resolution HLA genotyping, comprehensive infectious disease screening. Same donor pool for RUO and GMP products. ### LeukoPAK Products Q: What equipment is used for leukapheresis? A: FDA-approved Terumo BCT Spectra Optia, performed by HemaCenter. Q: What anticoagulant is used? A: ACD-A for LeukoPAK products. CPD for cord blood (HematoPAC). Q: Does OrganaBio offer mobilized donor leukopaks? A: No. Only healthy, non-mobilized donors meeting strict inclusion/exclusion criteria. Q: What is the volume of a fresh LeukoPAK? A: Averaging ~150mL with ~10 billion total nucleated cells (TNC). Q: What is the volume of a frozen half LeukoPAK? A: Averaging ~150mL (1:1 dilution with cryoprotectant), ~5 billion TNC. Q: How are donors characterized? A: Age, sex, BMI, smoking status, race/ethnicity, blood type, antigen reactivity. Screened for HIV, HBV, HCV, HTLV, T. pallidum, WNV, T. cruzi, CMV, EBV. Immunophenotyping and HLA genotyping (6-digit by NGS). Q: What is the donor recall rate? A: 500+ recallable donors managed through HemaCenter's donor relationship program. High recallability for repeat collections. ### Isolated Cells Q: How are cells isolated? A: Manual or automatic magnetic bead separation (positive or negative selection). CliniMACS Prodigy available. Custom procedures offered. Q: Are cells from single or pooled donors? A: Always single donor to facilitate clinical manufacturing and tech transfer. Q: Are cells HLA-typed? A: Yes. High-resolution HLA typing by Next Generation Sequencing (NGS) providing 6-digit HLA genotype for HLA-A, -B, -C, -DR, -DB, -DQ. KIR typing available upon request. Q: What is the cryopreservation process? A: Controlled rate freezing (CRF) with CryoStor CS10 cryoprotectant. Stored in vapor phase liquid nitrogen (LN2). ### MSC Products Q: What formats do MSCs come in? A: Cryopreserved cells, vialed from 1-10 million MSC per vial depending on cell type. Test kits with cells and media available. Q: How are MSCs characterized? A: Viability, purity, cell identity, trilineage differentiation, expansion potential, sterility, mycoplasma, endotoxin testing. Q: Are MSCs from single or pooled donors? A: Always single donor. Robust bioprocess media enables large lot production from individual donors. Q: Does OrganaBio offer donor-matched MSCs? A: Yes. Can source from placenta and umbilical cord tissue simultaneously from the same donor. Can combine with matched HSC and immune cells. --- ## Locations Miami, FL (headquarters) — Cell collection, processing, cryopreservation, cGMP manufacturing, assay development Irvine, CA — West coast processing facility Facilities feature co-located collection and processing to minimize transit time (< 30 min to processing). URL: https://www.organabio.com/locations/ --- ## Case Studies - Delivering RUO & GMP Leukopak collections to Singapore: https://www.organabio.com/case-study-leukopac-collections-to-singapore/ - OrganaBio's Hub Processing Model: https://www.organabio.com/case-study-organabios-hub-processing-model/ --- ## Key Blog Posts / Educational Content - Perinatal Tissue Sources for Allogeneic Cell Therapy: https://www.organabio.com/perinatal-tissue-allogeneic-cell-therapy-guide/ - Disease-State Donor Samples for Cell Therapy: https://www.organabio.com/disease-state-donor-samples-cell-therapy/ - Co-Located Cell Collection and Processing for Clinical Trials: https://www.organabio.com/co-located-cell-collection-processing-clinical-trials/ - What Is a Leukopak?: https://www.organabio.com/what-is-a-leukopak-and-how-do-you-source-quality-material-for-cell-therapy/ - The Real Cost Per Usable Cell — TCO Model: https://www.organabio.com/the-real-cost-per-usable-cell-building-a-scientist-friendly-tco-model/ - PBMC Thaw and Recovery Guide: https://www.organabio.com/pbmc-thaw-and-recovery-the-small-moves-that-change-your-data/ - CD34+ HSC Isolation Determinants: https://www.organabio.com/successful-cord-blood-cd34-hsc-isolation-determinants-quality-quantity-and-timing/ - Fresh or Frozen? The Cryopreservation Dilemma: https://www.organabio.com/fresh-or-frozen-navigating-the-cryopreservation-dilemma-for-cgt/ - NK Cells: Born to Kill: https://www.organabio.com/nk-cells-born-to-kill/ - The Story of T Lymphocytes: https://www.organabio.com/the-story-of-t-lymphocytes/ - Lymphocytes — Adult PB vs Cord Blood: https://www.organabio.com/a-comparison-of-lymphocytes-from-adult-peripheral-blood-versus-umbilical-cord-blood/ - MSC-omics for Characterization: https://www.organabio.com/msc-omics-the-next-frontier-for-msc-characterization-and-standardization/ - Ethics of Cord Blood Collection: https://www.organabio.com/wait-a-minute-the-ethics-of-cord-blood-collection/ - Decentralizing Cryopreservation: https://www.organabio.com/decentralizing-cryopreservation-to-improve-cell-and-gene-therapy-trial-logistics/ - OrganaBio's Recallable Donor Pool: https://www.organabio.com/the-organabio-method-for-cultivation-of-a-highly-recallable-leukapheresis-donor-pool/ - The cGMP Manufacturing Facility: https://www.organabio.com/the-organabio-cgmp-manufacturing-facility/ - Breaking the Healthy Donor Paradigm — Lupus: https://www.organabio.com/breaking-the-healthy-donor-paradigm-why-lupus-patients-are-revolutionizing-cell-therapy-development/ --- ## Sitemap https://www.organabio.com/sitemap_index.xml