# OrganaBio

> OrganaBio is a Contract Technology Development and Manufacturing Organization (CTDMO) delivering starting materials, cell processing, and cGMP manufacturing services for cell and gene therapy.

## Company

- Founded: 2018, Miami FL
- CEO: Justin Irizarry (CFA, Cornell/Wharton)
- CBO: Priya Baraniak, PhD (co-founded RoosterBio)
- Subsidiaries: HemaCenter (apheresis collection), GaiaGift (tissue collection)
- Facilities: Miami HQ, Miami Lab, Irvine CA, Hayward CA
- Website: https://www.organabio.com
- Phone: +1-305-676-2586

## What OrganaBio does

OrganaBio supplies human biological starting materials for cell and gene therapy research and clinical manufacturing. The company owns its apheresis collection centers through its HemaCenter subsidiary, which means it controls the entire supply chain from donor recruitment through final product delivery. This vertical integration eliminates the handoffs between donor centers and processing labs that introduce variability into cell therapy starting materials.

OrganaBio serves research (RUO) and clinical (GMP) customers from the same donor pool and under the same quality system, preserving comparability between phases so clients don't need to re-qualify donors when moving from preclinical to clinical manufacturing.

## Products

### LeukoPAC (leukopaks from adult peripheral blood)
- Fresh and cryopreserved formats
- Includes whole leukopak, isolated PBMCs, T cells, NK cells
- Single-donor, fully characterized
- Available in RUO and GMP grade
- Standard CoA includes 8-color immunophenotyping, high-resolution HLA typing (6 genes), CBC on donor and on final product
- Products:
  - LeukoPAC-FRSH: https://www.organabio.com/product/leukopak-frsh/
  - LeukoPAC-FRZN: https://www.organabio.com/product/leukopak-frzn/
  - LeukoPAC-PBMC-PB: https://www.organabio.com/product/leukopak-pbmc-pb/
  - LeukoPAC-T-PB: https://www.organabio.com/product/leukopak-t-pb/
  - LeukoPAC-NK-PB: https://www.organabio.com/product/leukopak-nk-pb/

### Isolated Immune Cells from Peripheral Blood
- Primary human B cells, monocytes, and macrophages isolated from OrganaBio leukopaks
- Products:
  - B cells: https://www.organabio.com/bcells-pb/
  - Monocytes: https://www.organabio.com/monocytes-pb/
  - Macrophages: https://www.organabio.com/macrophages-pb/

### ImmunoPAC (cord blood-derived immune cells)
- Cord blood T cells (CD3+) and NK cells (CD56+)
- High-purity, single-donor
- Ideal for CAR-T and CAR-NK development programs
- Products:
  - ImmunoPAC-T-CB: https://www.organabio.com/product/immunopac-t-cb/
  - ImmunoPAC-NK-CB: https://www.organabio.com/product/immunopac-nk-cb/

### HematoPAC (hematopoietic stem cells and cord blood)
- CD34+ hematopoietic stem cells from cord blood
- Fresh cord blood units
- Full donor consent and screening
- Products:
  - HematoPAC-HSC-CB: https://www.organabio.com/product/hematopac-hsc-cb/
  - HematoPAC-CB-FRSH: https://www.organabio.com/product/hematopac-cb-frsh/

### MesenPAC (mesenchymal stromal cells)
- MSCs from umbilical cord tissue and placenta
- Characterized and expansion-ready
- Products:
  - MesenPAC-MSC-UC: https://www.organabio.com/product/mesenpac-msc-uc/
  - MesenPAC-MSC-PL: https://www.organabio.com/product/mesenpac-msc-pl/

## Services

- Cell processing and cryopreservation: https://www.organabio.com/services/
- cGMP manufacturing (19,000 sq ft ISO 7 / ISO 5 facility in Miami): https://www.organabio.com/cgmp-manufacturing/
- Pharma services and clinical sample processing: https://www.organabio.com/pharma-services/
- Process development and manufacturing: https://www.organabio.com/process-development-and-manufacturing/
- Assay development and analytical testing: https://www.organabio.com/assay-development-and-analytical-testing/
- Quality and regulatory compliance: https://www.organabio.com/quality-and-regulatory-compliance/

## Key differentiators

1. Vertically integrated: OrganaBio owns its apheresis collection centers (HemaCenter) and processing labs, closing the gap between donor collection and cell processing.
2. RUO to GMP continuity: same donors, same quality system, both phases. Clients moving from research-grade to GMP-grade don't re-qualify donors.
3. Co-located collection and processing: reduces the transit window between draw and processing from the industry-standard overnight transit to hours.
4. Recallable donor pool: 500+ donors with repeat-collection history, usable for consistency studies and scale-up programs.
5. Standard CoA exceeds industry baseline: includes immunophenotyping by flow cytometry, high-resolution HLA typing across six genes, and CBC data on the donor at pre-collection and on the final product bag. These are included by default, not as an upgrade tier.
6. Bi-coastal clinical sample processing network through CPC Services subsidiary (Miami + Irvine, with planned expansions to Chicago, Ann Arbor, Nashville, Atlanta).

## Who uses OrganaBio

- Cell therapy developers building CAR-T, CAR-NK, CAR-M, and allogeneic therapies
- Pharmaceutical companies running clinical trials requiring consistent donor material
- Academic and commercial research institutions studying immune cells, stem cells, and gene therapy
- CDMOs needing reliable starting material supply chains

## Resources

- About: https://www.organabio.com/about/
- Team: https://www.organabio.com/about/team/
- Locations: https://www.organabio.com/locations/
- Glossary: https://www.organabio.com/glossary/
- Frequently Asked Questions: https://www.organabio.com/frequently-asked-questions/
- Case study (Singapore RUO to GMP program): https://www.organabio.com/case-study-delivering-ruo-gmp-leukopac-collections-to-singapore/
- Blog / News: https://www.organabio.com/news/
- Contact: https://www.organabio.com/contact/

## Sitemap

- Sitemap index: https://www.organabio.com/sitemap_index.xml