What OrganaBio does

OrganaBio is a vertically integrated Contract Testing, Development, and Manufacturing Organization (CTDMO) for cell and gene therapies, founded in 2018 and headquartered in Miami, Florida. The company supplies GMP-grade starting materials including leukopaks, peripheral blood mononuclear cells (PBMCs), isolated immune cell subsets (CD3+ T cells, CD56+ NK cells, CD19+ B cells, CD14+ monocytes), cord blood-derived products, CD34+ hematopoietic stem cells, and mesenchymal stromal cells, sourced from a 1,000+ qualified, recallable donor pool via its wholly-owned FDA-registered subsidiaries HemaCenter (apheresis) and GaiaGift (perinatal tissue). Each donor is screened against 14 infectious disease markers under 21 CFR 1271 and characterized with NGS HLA typing across six genes and KIR genotyping for NK cell therapy programs. Disease-state material from donors with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Crohn's disease, ulcerative colitis, and celiac disease supports autoimmune drug discovery and biomarker research.

The company's service portfolio includes cGMP manufacturing in ISO 7 cleanrooms (a 19,000 sq ft flagship facility in Miami and five suites at Excellos Labs in San Diego, acquired in May 2026), clinical cell processing and cryopreservation with 30-minute turnaround and 99.1% reported cell viability across 2,500+ clinical samples, and custom assay development including flow cytometry up to 25 colors, immunophenotyping, cytotoxicity, ADCC, PCR, and endotoxin testing. OrganaBio operates bi-coastally with sites in Miami, Irvine, Hayward, and San Diego, and is expanding to Atlanta, Houston, Chicago, Detroit, Memphis, and Nashville.

Revenue is generated through direct enterprise sales of cell and tissue products (RUO and cGMP grades from the same donor pool) and professional services including contract manufacturing, clinical sample processing, and analytical testing. Customers comprise top-20 global pharmaceutical companies, biotechnology developers of CAR-T, gene therapy, and advanced immunotherapy programs, and clinical trial sites requiring local sample processing. Pricing is quote-based and project-specific. The go-to-market relies on regional scientific sales directors covering West Coast and Asia markets, industry conference presence (BIO, ISCT, ISSCR, J.P. Morgan Healthcare Conference), and thought-leadership content via the Supply Brain editorial platform.

Name

OrganaBio

Legal name

OrganaBio, LLC

Website

https://organabio.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

OrganaBio is a Miami-headquartered, bi-coastal cell and gene therapy CTDMO founded in 2018 that supplies GMP-grade leukopaks, immune cells, and cord blood products from a recallable donor pool, and provides cGMP manufacturing, cryopreservation, and analytical testing services to pharmaceutical, biotechnology, and clinical trial customers.

Ownership category

akta.pro rank

Product category

Cell and Gene Therapy Contract Manufacturing (CTDMO)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Blood and Organ Banks (621991), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC)

akta.pro secondary industry

Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI)

Keywords

• Cell therapy manufacturing
• Cell therapy starting materials
• Leukopak products
• CGMP contract manufacturing
• Cord blood derived cells

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Cell and Tissue Products: Sale of donor-derived starting materials including leukopaks, PBMCs, isolated immune cells (T cells, NK cells, B cells, monocytes), cord blood products, and mesenchymal stem cells. Available in RUO and cGMP grades from the same donor pool.
2. cGMP Manufacturing Services: Contract manufacturing services for cell therapy products including technology transfer, process development, clinical production, and analytical testing. Services support CAR-T, gene therapy, and advanced immunotherapy programs from preclinical through clinical phases.
3. Clinical Cell Processing and Cryopreservation: Clinical sample processing services for clinical trials including PBMC isolation, cryopreservation, and cold storage. Services support both autologous and allogeneic cell therapy programs.
4. Assay Development and Testing: Analytical testing and assay development services including immunophenotyping, cytotoxicity assays, ADCC assays, flow cytometry (up to 25 colors), endotoxin testing, and stability studies.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

OrganaBio is a vertically integrated Contract Testing, Development, and Manufacturing Organization (CTDMO) supplying donor-derived cellular starting materials (leukopaks, PBMCs, isolated T/NK/B/monocyte subsets, cord blood CD34+ HSCs, MSCs, and disease-state serum/plasma) alongside cGMP contract manufacturing, clinical cell processing and cryopreservation, and assay development services for cell and gene therapy developers. Its offerings are delivered through wholly-owned FDA-registered subsidiaries HemaCenter (apheresis) and GaiaGift (perinatal tissue) plus the acquired Excellos Labs (San Diego cGMP), with bi-coastal ISO 7 manufacturing capacity serving pharmaceutical companies, biotech firms, and clinical trial sponsors.

Product overview

OrganaBio is a vertically integrated Contract Testing, Development and Manufacturing Organization (CTDMO) founded in 2018, providing GMP cells, blood products, and end-to-end cell therapy manufacturing services. The product portfolio includes: Leukopak Apheresis-Derived Products (fresh and frozen leukopaks from healthy and disease-state SLE donors), ImmunoPAC cord blood-derived immune cells (T cells, NK cells), peripheral blood mononuclear cells, isolated immune cell subsets (CD3+ T cells, CD56+ NK cells, CD19+ B cells, CD14+ monocytes), monocyte-derived macrophages (M0/M1/M2 phenotypes), HematoPAC HSCs and cord blood products (CD34+ hematopoietic stem cells, fresh cord blood units), MesenPAC mesenchymal stromal cells (umbilical cord and placenta-derived), and HemaPAC disease-state serum and plasma (SLE donors). Services include clinical cell processing and cryopreservation, cGMP manufacturing (Miami 19,000 sq ft flagship and San Diego Excellos Labs with 5 ISO 7 cleanroom suites), and assay development and analytical testing. The company operates wholly-owned subsidiaries HemaCenter (apheresis) and GaiaGift (perinatal tissue) for vertically integrated supply chain control, with facilities in Miami, San Diego, San Francisco, and Irvine.

Differentiator

Problem solved

Functional benefit

Brands

• ImmunoPAC™: Product line for cord blood-derived immune cells including T cells, NK cells from peripheral blood and cord blood
• HematoPAC™
• MesenPAC™
• HemaPAC™
• Leukopak
• Supply Brain
• NeoPAC™

Products and services

• Fresh Leukopak (Healthy) Fresh leukopaks from healthy adult peripheral blood (10 billion or more cells per single-donor unit) collected via FDA-approved Terumo Spectra Optia apheresis system, delivered same-day or next-day for CAR-T and gene therapy starting material programs.
• Frozen Leukopak (Healthy) Cryopreserved leukopaks from healthy donors (10 billion or more cells per single-donor unit) offering high post-thaw viability and flexible scheduling for cell and gene therapy starting material programs.
• Frozen Leukopak (SLE/Lupus) Cryopreserved disease-state leukopaks from donors with Systemic Lupus Erythematosus for autoimmune research and disease-mechanism studies, with full 14-marker infectious disease screening and NGS HLA typing.
• Peripheral Blood Mononuclear Cells (Healthy) Cryopreserved PBMCs from healthy donors with 99.1% post-thaw viability, 70%+ PBMC recovery, and average composition of 60% T cells and 18% NK cells for immunology research, drug screening, and cell and gene therapy starting material across preclinical to clinical use.
• Peripheral Blood Mononuclear Cells (SLE/Lupus) Disease-state PBMCs from donors with documented Systemic Lupus Erythematosus for autoimmune drug screening, biomarker discovery, and disease-state immune dysregulation studies.
• CD3+ T Cells (Peripheral Blood) Cryopreserved human pan T cells isolated via CD3+ negative selection from peripheral blood leukopaks for CAR-T development, TCR engineering research, and adoptive cell therapy preclinical work, with KIR genotyping available.
• CD56+ NK Cells (Peripheral Blood) Cryopreserved peripheral blood-derived CD56+ natural killer cells for immunotherapy, cytotoxicity research, and NK-cell-therapy programs, with KIR genotyping to support prospective donor selection for allogeneic NK cell therapy programs.
• CD19+ B Cells (Peripheral Blood) Cryopreserved CD19+ B cells isolated via negative selection from peripheral blood leukopaks for antibody discovery, BCR sequencing, and anti-CD19 CAR-T target validation.
• CD14+ Monocytes (Peripheral Blood) Cryopreserved CD14+ monocytes from peripheral blood leukopaks used as common starting material for macrophage and dendritic cell differentiation studies and innate immunity research.
• Monocyte-Derived Macrophages Pre-differentiated monocyte-derived macrophages available as M0 (unpolarized), M1 (pro-inflammatory), or M2 (anti-inflammatory) phenotypes for phagocytosis assays, drug screening, and tumor immunology research.
• CD34+ Hematopoietic Stem Cells (Cord Blood) Cryopreserved cord blood-derived CD34+ hematopoietic stem cells for HSCT research, gene therapy programs, and allogeneic cell and gene therapy starting material where lower GvHD risk and easier HLA matching matter.
• HematoPAC Fresh Cord Blood Fresh whole cord blood units processed within hours of collection from GaiaGift's perinatal network under IRB-approved consent with 14-marker infectious disease screening for research applications requiring unprocessed starting material.
• CD3+ T Cells (Cord Blood) Cryopreserved cord blood-derived T cells with naive T cell-enriched profile for cord-blood T-cell biology research, allogeneic CGT preclinical work, and programs needing cord-blood-specific T cell phenotypes.
• CD56+ NK Cells (Cord Blood) Cryopreserved cord blood-derived NK cells with naive phenotypes for cord-blood NK cell therapy programs, NK biology research, and allogeneic NK cell therapy preclinical work, with KIR genotyping available.
• Mesenchymal Stem Cells (Umbilical Cord) Cryopreserved umbilical cord-derived mesenchymal stromal cells sourced through GaiaGift with demonstrated 7-day 10x expansion capacity for regenerative medicine, immunomodulation studies, and MSC-based cell therapy preclinical programs.

Quantifiable outcome

• 99.1% average cell viability across 2,500+ clinical samples
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered core.

• Excellos Inc.coreOthers · 13 May 2026Acquisition of substantially all operating assets of San Diego-based Excellos Inc. to create a bicoastal cell therapy CTDMO. Newly formed Excellos Labs subsidiary oversees San Diego operations, adding 5 ISO 7 cGMP cleanroom suites and West Coast manufacturing capacity.
• NeurogenesiscoreStrategic or Co-development Partner · 5 May 2026Joint project approved for $7.5 million BIRD Foundation grant funding. Collaboration between U.S. and Israeli companies focused on advancing neurogenesis-related cell therapy research and development.
• RxMP TherapeuticscoreStrategic or Co-development Partner · 22 April 2026Manufacturing partnership for cGMP production of RMP-402, a first-in-class hemostatic therapeutic targeting severe hemorrhage in both civilian and military settings. Agreement covers technology transfer, qualification, and cGMP production leveraging OrganaBio's integrated manufacturing infrastructure.

Scale indicators9 records

Recent moves13 records

Expansion highlights7 records

Direct peers

• Lonza: Global CDMO with one of the largest cell and gene therapy manufacturing footprints, offering process development, cGMP manufacturing, and starting materials to cell therapy developers — directly competing with OrganaBio's CTDMO services across autologous and allogeneic programs.
• Catalent: Major CDMO with cell therapy development and manufacturing capabilities (including Paragon Bioservices) serving gene therapy and cell therapy developers. Competes directly with OrganaBio in process development, viral vector, and cell therapy manufacturing services.
• Charles River Laboratories: Provides cell therapy CDMO services, starting materials, and preclinical/clinical support through its Cell & Gene Therapy CDMO segment. Overlaps with OrganaBio in cGMP cell processing, cryopreservation, and contract manufacturing offerings.
• CellGenix: Supplies GMP-grade raw materials (cytokines, growth factors, cell culture media) for cell and gene therapy manufacturing. Closely comparable to OrganaBio's starting materials business (RUO and cGMP leukopaks, immune cells, MSCs) and serves the same customer base of cell therapy developers.
• Bio-Techne: Develops and manufactures cell culture reagents, cytokines, and differentiation kits used in cell therapy manufacturing. Comparable to OrganaBio as a supplier of foundational materials for cell therapy R&D and manufacturing.
• Aldevron (Danaher): Provides cGMP nucleic acids, proteins, and cell therapy manufacturing services to gene therapy and cell therapy developers. Overlaps with OrganaBio in CTDMO services and team experience (an OrganaBio CPC Services leader previously worked at Aldevron).
• Miltenyi Biotec: Offers cell separation technology (CliniMACS), reagents, and contract cell processing/manufacturing services for cell therapy developers. Directly comparable to OrganaBio's immune cell isolation products (T cells, NK cells, B cells, monocytes) and cGMP manufacturing services.
• RoslinCT: Dedicated cell therapy CDMO providing process development, GMP manufacturing, and cryopreservation for cell therapy developers. Highly comparable in business model and customer base to OrganaBio's CTDMO offering, particularly in allogeneic and autologous cell therapy manufacturing.
• Fujifilm Cellular Dynamics: Develops and manufactures iPSC-derived cell products and offers cell therapy contract manufacturing services. Comparable to OrganaBio in differentiated cell products (e.g., monocyte-derived macrophages) and cGMP cell therapy manufacturing capabilities.

Broad incumbents

• Thermo Fisher Scientific (Patheon): Operates a broad pharma services network including cell therapy capabilities, biorepository services, and clinical trial sample logistics through its PPD clinical research arm. Overlaps with OrganaBio's clinical cell processing and cryopreservation services for cell therapy trials, but cell therapy is one segment of a much larger services portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/organabio
• Facebookfacebook.com/organabio
• LinkedInlinkedin.com/company/organabio
• Instagraminstagram.com/organabiocells

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about OrganaBio