OrganaBio


OrganaBio is dedicated to supporting the development of life-changing cell and gene therapies by providing high-quality human biological products, clinical cell processing, cryopreservation services, and advanced characterization techniques such as MSC-omics. Founded in 2018, the company aims to alleviate bottlenecks in raw material supply and expand options for cGMP manufacturing, enabling regenerative medicine industry growth. With a proprietary supply chain, ethical tissue collection, and innovative research support, OrganaBio supplies cellular starting materials like birth tissue-derived cells, immune cells, and MSCs, and is developing state-of-the-art manufacturing facilities to meet industry needs. The company is committed to advancing MSC characterization and standardization, enabling targeted therapeutic strategies and supporting cutting-edge preclinical and clinical advancements.

Industries

biotechnology

Nr. of Employees

small (1-50)

OrganaBio

Miami, Florida, United States, North America


Products

Apheresis-derived leukopak units and PBMC/T/NK cell subsets (fresh or frozen)

Scalable peripheral blood-derived leukopak units and isolated peripheral blood mononuclear cells (PBMCs), as well as enriched T-cell and NK-cell subsets available as fresh or cryopreserved material for research and development.

Perinatal tissue-derived mesenchymal stromal cell preparations (umbilical cord, placenta)

Mesenchymal stromal cell products isolated from umbilical cord and placenta available in cryopreserved formats for research and clinical development.

Cord blood-derived immune cell products and hematopoietic stem cell (CD34+) preparations

Cord blood-derived products including immune cell isolates (T cells, NK cells) and hematopoietic stem cell (CD34+) preparations provided fresh or frozen for development and translational use.

Cryopreserved HLA-typed T-cell and NK-cell products from cord blood

Cryopreserved cord blood-derived T-cell and NK-cell products with reported immunophenotype and HLA genotype for use as starting material in allogeneic cell therapy programs.


Services

Clinical cell processing and cryopreservation

Rapid, localized processing of clinical samples including cell isolation from whole blood and apheresis, analytical testing, controlled-rate freezing and cold storage for clinical trials.

cGMP process development and contract manufacturing for cellular therapies

cGMP-compliant manufacturing and process development for human cellular therapy products using ISO-class cleanrooms, validated equipment and SOP/master batch record governance.

Donor selection, qualification and custom starting material services

Custom product development to match donor criteria and product specifications, leveraging controlled donor recruitment, IRB-approved consent and HLA/KIR-typed donor inventory.

Clinical site support and trial logistics

Hands-on support for trial sites including training, on-site coordination, sample logistics and consultation on clinical processing workflows.

Expertise Areas

  • Clinical cell processing and sample logistics
  • Cryopreservation and cold-chain management
  • cGMP process development and clinical manufacturing for cellular therapies
  • Perinatal and peripheral blood-derived starting materials
  • Show More (4)

Key Technologies

  • Next-generation sequencing (NGS) for HLA genotyping
  • RNA sequencing (RNAseq) / transcriptomics
  • Proteomics and secretome analysis
  • Extracellular vesicle (EV) / exosome isolation methods
  • Show More (5)

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