Industry-Best Rapid and Reliable PBMC Isolation, Cryopreservation, Storage, and Logistics

OrganaBio’s trial support services are focused on fast and efficient processing of blood samples from clinical trial patients to isolate peripheral blood mononuclear cells (PMBCs) before cryopreservation, cold storage, and shipping to the Sponsor’s lab. With bicoastal CPC Services located in Irvine and Miami and planned expansions into Chicago, Ann Arbor, Nashville, and Atlanta, we aim to establish local processing sites to support clinical research locations lacking PBMC processing capabilities and to shorten the time from sample collection to processing and cryopreservation. We also provide access to highly diverse populations of clinical trial participants and donor tissues.

Cell Processing and Cryopreservation Service
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Samples processed in the past 24 mo.

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Sample processing success rate

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Million PBMC isolated/mL blood

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Cell viability post processing

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Minutes from sample receipt

A Bi-Coastal Clinical Sample Processing and Cryopreservation Hub to Support Clinical Trials

Strategically Selected
Bi-Coastal Locations

Strategically Selected
Bi-Coastal Locations

  • Currently fully operational in South FL and Southern CA
  • Next processing lab location: Atlanta, GA
  • Operationalization in 6 weeks for large pharma

Integrated
Project Management

Integrated
Project Management

  • Efficient communication with pharma client, clinical site/CRO, and courier
  • Flawless tech transfer (SOPs, assays)
  • Easy access to leadership

Exceptional Support
and Quality Services

Exceptional Support
and Quality Services

  • Operator training and qualification
  • All locations under unified eQMS
  • FDA inspected
  • 0 shipping deviations
  • GMP compliance
  • Part 11 compliance

Clinical Trial
Sample Processing

Clinical Trial
Sample Processing

  • Time sensitive isolation of PBMCs, serum or plasma from whole blood for PK, PD, and immune monitoring
  • Apheresis material collection
  • Time from sample receipt to processing start <30 minutes

Cryopreservation

Cryopreservation

  • PBMCs, serum, or plasma
  • Clinical grade leukopak cryopreservation for autologous or allogeneic therapy
  • All processes governed by approved SOPs and MBRs
  • Cold storage and logistics

Connect with Us Today!

Connect with Us Today!

Partner with Us

Our culture of operational excellence has established a successful track record with pharma.

Same-Day Sample Processing due to Geographically Distributed Hubs

With a bicoastal presence and planned expansions in the Midwest and Southeast, OrganaBio offers quick turnaround times, flexibility, and customization – including a variety of solutions to meet your program’s unique needs.

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Same-Day Sample Processing due to Geographically Distributed Hubs

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  • Cell Processing
  • Cryopreservation
  • Dedicated Long-Term Storage
  • Birth Tissue Collection Network
  • Leukapheresis Center
  • Cell Processing
  • Cryopreservation
  • ISO7 Cleanrooms for cGMP Compliance
  • Manufacturing, QC, and Analytical Testing
  • Dedicated Long-Term Storage
Expansion site
Expansion site
Expansion site
Expansion site
Expansion site
Expansion site

Demonstrated Success

OrganaBio’s unique Hub Processing model is the cornerstone of Sponsors’ clinical trial success. It ensures fast and efficient sample processing and cryopreservation. Our exceptional track record, an experienced, trained, and qualified team, and a consistent quality management system across geographies ensure efficient technology transfer and proven accuracy. OrganaBio’s client-centric and data-driven approach enables seamless operations between Sponsors, clinical sites, and OrganaBio’s dedicated staff.