Enabling Excellence in the Delivery of Life-Changing Therapies

OrganaBio, founded in 2018, supplies cell and gene therapy starting materials and clinical cell processing and cryopreservation services.

Headquartered in Miami, FL, OrganaBio partners with its wholly-owned centers, GaiaGift and HemaCenter, to ethically source and collect birth tissue and peripheral blood. To support your therapeutic development journey, we provide highly characterized fresh, frozen, or cryopreserved whole blood cells in multiple isolated cell subsets, available in both research and GMP grades.

We also leverage our extensive expertise in cell isolation and cryopreservation to provide localized and rapid cell isolation from whole blood, analytical testing, cryopreservation, and cold storage of clinical trial samples, as well as autologous apheresis to support cell therapy delivery from both our East and West Coast facilities in Miami and Irvine, CA.

Enabling Excellence in the Delivery of Life-Changing Therapies

OrganaBio, founded in 2018, supplies cell and gene therapy starting materials and clinical cell processing and cryopreservation services.

Headquartered in Miami, FL, OrganaBio partners with its wholly-owned centers, GaiaGift and HemaCenter, to ethically source and collect birth tissue and peripheral blood. To support your therapeutic development journey, we provide highly characterized fresh, frozen, or cryopreserved whole blood cells in multiple isolated cell subsets, available in both research and GMP grades.

We also leverage our extensive expertise in cell isolation and cryopreservation to provide localized and rapid cell isolation from whole blood, analytical testing, cryopreservation, and cold storage of clinical trial samples, as well as autologous apheresis to support cell therapy delivery from both our East and West Coast facilities in Miami and Irvine, CA.

Our Mission

At OrganaBio, our mission is to provide high-quality, customizable materials and services to empower therapeutic developers, accelerate innovation, and improve patient outcomes. We are committed to a culture of providing ethically sourced raw materials from donors. This commitment to ethical sourcing is at the core of our operations. It is a crucial part of supporting your therapeutic development journey with a solutions-focused approach. Trust OrganaBio to provide you with the highest quality materials and services, all sourced ethically.

Our Work

OrganaBio is dedicated to providing high-quality products and services for cell therapy and clinical trials. Our unwavering dedication to quality and reliability ensures that you can trust in the precision and consistency of our offerings. We offer ethically sourced biological products and cell processing solutions to support therapeutic developers. Our focus is on precision, reliability, and exceptional customer support. Explore how OrganaBio can elevate your research and clinical outcomes.

Products

OrganaBio offers a wide range of ethically sourced human biological products. These include fresh, frozen, and cryopreserved whole blood and isolated cells to support cell therapy development and clinical trials. Our product offerings are available in research-grade and GMP-compliant formats, including leukopaks, PBMCs, T-cells, NK cells, MSCs, cord blood, and more. OrganaBio provides customizable and off-the-shelf options, ensuring fast, reliable delivery and maintaining a highly recallable donor pool for consistent supply chain support. Each product undergoes stringent quality control, including HLA typing and infectious disease testing, and comes with a Certificate of Analysis to guarantee safety and traceability, making them ideal for therapeutic development and clinical applications.

Services

OrganaBio offers a comprehensive suite of clinical cell processing and cryopreservation services designed to support cell therapy delivery and clinical trials across the U.S. Our specialization in rapid isolation, cryopreservation, and autologous apheresis of Peripheral Blood Mononuclear Cells (PBMC) ensures precise samples and high viability. We deliver reliable results with a track record of 99.9% processing accuracy and 99.1% cell viability. Our team fosters strong relationships with trial sites and sponsors through Subject Matter Expert (SME) support and project management. In addition to processing, OrganaBio provides assay development and analytical testing services such as cell enumeration and endotoxin analysis, all of which adhere to the highest industry standards.
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We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.

Process 1
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We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.

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microscope

The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.

about tabs shape 1
microscope

The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.

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OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.

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about tabs shape 2

OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.

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All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.

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about tabs shape 3

All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.

checklist
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OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.

checklist
about tabs shape 4

OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.

Process 1
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We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.

Process 1
quote bg

We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.

about tabs shape 1
microscope

The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.

about tabs shape 1
microscope

The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.

shield
about tabs shape 2

OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.

shield
about tabs shape 2

OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.

magnify
about tabs shape 3

All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.

magnify
about tabs shape 3

All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.

checklist
about tabs shape 4

OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.

checklist
about tabs shape 4

OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.

Our Partners and Memberships

Meet Our Team of Experts

Our team, with its extensive experience in academic institutions, start-ups, biotechs, and pharmaceutical companies, is the backbone of OrganaBio. This wealth of knowledge and expertise makes OrganaBio a trusted partner for our clients, ensuring we can provide the highest service and support.