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OrganaBio

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Year Established:
2019
Website:
organabio.com
Headquarters:
South Miami, FL, US
Company Type:
Small Business (1-10M TTM Revenue)
Professional Associates:
BIOCOM, BioFlorida

- Isolated cells from peripheral and cord blood: PBMCs, T cells, NK cells, Gamma Delta cells, macrophages, dendritic cells, CD34+ hematopoietic stem cells, and more.
- Leukopaks (fresh, frozen, whole, and quarters)
- Cord blood units (fresh, frozen)
- Whole tissues, including whole blood, placenta, cord tissue, and neonatal foreskin
- Cell isolation and cryopreservation services for large pharmaceutical phased trials

Leading pharmaceutical companies and cell and gene therapy developers partner with OrganaBio to supply isolated cells and tissues for therapeutic drug manufacturing, phased trials, engineering runs, and process development activities.

OrganaBio’s top-tier quality products, custom donor screening services, collaborative customer relationships, superior customer service, meticulous attention to detail, and vertically integrated operations contribute significantly to its success.

OrganaBio owns and operates IRB-approved proprietary supply chains for peripheral blood and birth tissue, enabling it to source large quantities of fresh tissue from specific donor pools. All necessary functions for product manufacturing—cell isolation, cryopreservation, cGMP manufacturing, clean room operations, quality assurance, quality control, and regulatory activities—are performed in-house.

OrganaBio and its subsidiaries are FDA-registered blood and tissue establishments, and FDA inspected for these activities.

Together, these capabilities allow OrganaBio to engineer customized and highly specific RUO and GMP-grade supply solutions that are quickly operationalized and scalable. OrganaBio is committed to accelerating the commercialization of next-gen therapies with these capabilities.

Discover more about OrganaBio’s high-quality, ethically sourced tissues and cellular products at https://www.organabio.com/products/

HematoPAC™: Fresh umbilical cord blood, cord blood-derived CD34+ HSCs

ImmunoPAC™: Cord blood-derived T cells and NK cells

LeukoPAC™: Adult leukapheresis-derived leukopaks, PBMCs, T cells, and NK cells

Learn more about OrganaBio’s services and expertise at https://www.organabio.com/services

Process Development and Manufacturing: OrganaBio’s cGMP manufacturing facility includes advanced process development suites, an ISO 7 certified cleanroom, and an analytical testing core, all equipped with pre-qualified and fully validated scientific equipment. OrganaBio provides comprehensive support services including material receipt, inventory management, ambient, cold, and cryogenic short and long-term storage, laboratory and process environmental monitoring, a Part 11 compliant eQMS and operational monitoring system, restricted security, and facilities maintenance.

Assay Development and Analytical Testing: OrganaBio offers full-service laboratory science support to enhance your capabilities. Services include high-quality assays and testing in bioanalytics, immunology, and molecular biology. The OrganaBio Quality Control Core lab provides essential and validated testing and analysis services to ensure compliance in data integrity and regulatory documentation.

Clinical Sample Processing, Cryopreservation, and Storage: OrganaBio offers pharmaceutical companies a range of services that enable speed and flexibility in developing and manufacturing innovative cell therapies and vaccines. Learn more at https://www.cpcservices.com/

Site Badges
OrganaBio
7800 SW 57th Avenue South Miami, FL, 33143 United States
OrganaBio
7800 SW 57th Avenue South Miami, FL, 33143 United States
OrganaBio
7800 SW 57th Avenue South Miami, FL, 33143 United States
OrganaBio
7800 SW 5th Ave, Suite 225 South Miami, FL, 33143 United States
OrganaBio - Irvine (Trial Processing Lab)
5270 California Ave Irvine, CA, 92617 United States
OrganaBio
2420 NW 116th St Miami, FL, 33167 United States

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