# OrganaBio

> OrganaBio is a leading biotech CTDMO (Contract Technology Development and Manufacturing Organization) specializing in cell and gene therapy starting materials. Based in San Diego, CA with cGMP manufacturing in Miami, FL, OrganaBio provides ethically sourced human-derived cellular products from birth tissues (umbilical cord blood, placenta, cord tissue) and adult leukapheresis, along with full process development, cGMP manufacturing, and clinical trial support services.

This is an llms-full.txt file providing comprehensive information about OrganaBio for AI and LLM consumption.

## Key Pages
- [Post Order Feedback](https://www.organabio.com/order-feedback/)
- [Case Study: Delivering RUO & GMP Leukopak collections to Singapore](https://www.organabio.com/case-study-delivering-ruo-gmp-leukopac-collections-to-singapore/)
- [Certificate of Analysis](https://www.organabio.com/certificate-of-analysis/): Certificate of Analysis
- [Locations](https://www.organabio.com/locations/): Our Locations OrganaBio – HQ 7800 SW 57th Ave Suite 204 Miami, FL 33143 OrganaBio – Lab Site 2420 NW 116th St Suite 300 Miami, FL 33167 OrganaBio – Lab 5270 California Ave Suite 300, Irvine, CA 92617 
- [Cell Tissue Product Portfolio](https://www.organabio.com/product-portfolio/): Powering Your Research with High-Quality Biological Materials OrganaBio provides a comprehensive suite of products designed to help you accelerate research, improve reproducibility, and achieve reliab
- [Services](https://www.organabio.com/services/): Clinical Cell Processing & Cryopreservation Services Choose a single service or the full continuum: donor sourcing, clinical cell processing & cryopreservation, analytics, and cGMP manufacturing – all
- [Frequently Asked Questions](https://www.organabio.com/frequently-asked-questions/): FAQs Get answers to most frequently asked questions General MSC (Mesenchymal Stem/Stromal Cells) LeukoPAC™ Products Isolated Cells General What products does OrganaBio offer? OrganaBio offers human-de
- [Events](https://www.organabio.com/events/): Events Explore upcoming OrganaBio events and conferences participation, and discover where OrganaBio will be exhibiting next. Have questions? We are here to help you find the right materials for your 
- [Catalogs & Brochures](https://www.organabio.com/catalogs-brochures/): Download catalogs and brochures with up-to-date information and specifications about products and services OrganaBio offers. Have questions? We are here to help you find the right materials for your s
- [In the Media](https://www.organabio.com/in-the-media/): In the Media View the latest interviews, articles, and mentions of OrganaBio in the media. Have questions? We are here to help you find the right materials for your study. Contact Us
- [PBMCs Inventory](https://www.organabio.com/pbmcs-inventory/): Does the inability to procure donor materials with certainty hinder your experimental workflow? OrganaBio’s off-the-shelf adult apheresis-derived products inventory can circumvent issues of donor reca
- [Success Story: Delivering RUO & GMP Leukopak collections to Singapore](https://www.organabio.com/case-study-singapore-ruo-gmp/): Success Story: Delivering RUO & GMP LeukoPAK collections to Singapore OrganaBio met the client’s unique needs to rapidly provide PBMCs from 100 CMV+ donors for screening and donor qualification, to su
- [Thank you](https://www.organabio.com/thank-you/): Thank you for contacting OrganaBio. Our cell therapy experts will respond within 24 hours.
- [Cell Processing and Cryopreservation Services](https://www.organabio.com/pharma-services/): Industry-Best Rapid and Reliable PBMC Isolation, Cryopreservation, Storage, and Logistics OrganaBio streamlines blood sample processing to isolate and preserve PBMCs quickly, ensuring high-quality sam
- [Assay Development and Analytical Testing](https://www.organabio.com/assay-development-and-analytical-testing/): Assay Development & Analytical Testing Achieve the precision your program demands with comprehensive analytical testing and assay development designed to deliver accurate, reproducible, and audit-read
- [Quality and Regulatory Compliance](https://www.organabio.com/quality-and-regulatory-compliance/): Quality & Regulatory Compliance OrganaBio is committed to providing access to critical resources essential for therapeutic development while adhering to high standards of quality assurance and regulat
- [Team](https://www.organabio.com/about/team/): Our Team Our team has centuries of “in the field” experience working in a range of environments, from academic institutions to start-ups, small and large biotechs and pharmaceutical enterprises. This 
- [Products](https://www.organabio.com/products/): High Quality Donor Tissues for Gene and Cell Therapy Development Products Accelerate Discovery with Consistent, High-Quality Leukopaks and Cell Therapy Products Access high-quality donor tissues and t
- [Process Development and Manufacturing](https://www.organabio.com/process-development-and-manufacturing/): Process Development and Manufacturing​ Our team of industry veterans brings you decades of experience in the field of Process Development. OrganaBio specializes in isolating and characterizing a varie
- [Contact](https://www.organabio.com/contact/): Complete the form below, and a member of our team will contact you. Locations: HQ: 7800 SW 57th Ave | Suite 204 South Miami, FL 33143 GMP Facility: 2420 NW 116th Street | Suite 300Miami, FL 33167 Irvi
- [News](https://www.organabio.com/news/): News Read the latest announcements, news and press releases from OrganaBio. Have questions? We are here to help you find the right materials for your study. Contact Us
- [Supply Brain](https://www.organabio.com/supply-brain/): Supply Brain Learn about cell and gene therapy latest scientific research, developments, industry challenges and solutions.
- [About](https://www.organabio.com/about/): 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.
- [Success Story Form](https://www.organabio.com/contact/form/)
- [Home](https://www.organabio.com/): Comprehensive Cell and Gene Therapy Solutions Built for Advanced Developers Purpose-Built Cell & Gene Therapy Solutions OrganaBio is your agile, partner-focused provider of high-quality cell and gene 
- [Careers](https://www.organabio.com/careers/): Join Us to Support Innovative Cell Therapies OrganaBio is a Miami-based Contract Technology Development and manufacturing Organization (CTDMO) that provides tissue, cell products and a host of service
- [cGMP Manufacturing](https://www.organabio.com/cgmp-manufacturing/): OrganaBio cGMP Manufacturing Facility OrganaBio operates a state-of-the-art cGMP manufacturing facility in Miami, FL, supporting the clinical translation of cell therapies. We provide fully compliant 
- [Privacy Policy](https://www.organabio.com/privacy-policy/): Privacy Policy This Privacy Policy describes how the domain organabio.com (the “Site” or “we”) collects, uses, and shares your Personal Information when you visit or make a purchase from the Site. By 

## Products

### MesenPAC™-MSC-UC - Cryopreserved MSC Cells / Umbilical Cord Tissue
- URL: https://www.organabio.com/product/mesenpac-msc-uc/
- SKU: 10xMSC-UC-010
- Category: MesenPAC™ MSCs
- Description: Cryopreserved umbilical cord tissue-derived mesenchymal stromal cells (MSCs) for regenerative medicine, tissue engineering, and cell therapy development. Processed fresh within hours of birth for optimal viability. Ethically sourced with comprehensive QC data.

### MesenPAC™-MSC-PL - Cryopreserved Mesenchymal Stem Cells
- URL: https://www.organabio.com/product/mesenpac-msc-pl/
- SKU: 10xMSC-PL-010
- Category: MesenPAC™ MSCs
- Description: Cryopreserved placenta-derived mesenchymal stromal cells (MSCs) for regenerative medicine and cell therapy research. Placenta provides a superior non-invasive source with high cell yield and robust immunomodulatory properties. Ethically sourced with full QC data and Certificate of Analysis.

### LeukoPAK-T-PB - Human Pan T Cells (CD3⁺, Negatively Isolated) - Cryopreserved
- URL: https://www.organabio.com/product/leukopak-t-pb/
- SKU: T-PB-025
- Category: Leukopak Apheresis-Derived Products
- Description: Cryopreserved human pan T cells (CD3+, negatively isolated) from adult peripheral blood. Scalable sourcing from single vials to full leukopaks. Validated post-thaw viability and purity with transparent QC data. Comprehensive donor data including HLA profile, CMV/EBV reactivity, and recallable donors for long-term studies.

### LeukoPAK-PBMC-PB - Cryopreserved Peripheral Blood Mononuclear Cells
- URL: https://www.organabio.com/product/leukopak-pbmc-pb/
- SKU: PBMC-PB-100
- Category: Leukopak Apheresis-Derived Products
- Description: High-quality cryopreserved peripheral blood mononuclear cells (PBMCs) for immuno-oncology research, vaccine development, autoimmune disease studies, cell therapy development, and functional immune cell profiling. IRB-approved collection with Certificate of Analysis for each lot.

### Leukopak-NK-PB - Peripheral Blood-Derived Natural Killer (NK) Cells
- URL: https://www.organabio.com/product/leukopak-nk-pb/
- SKU: NK-PB-010
- Category: Leukopak Apheresis-Derived Products
- Description: Cryopreserved peripheral blood-derived CD56+ natural killer (NK) cells for immuno-oncology research, NK cell therapy development, functional NK cell assays, and cytotoxicity studies. Collected under IRB-approved protocols with Certificate of Analysis including viability, purity, and phenotype data.

### LeukoPAK-FRZN - Cryopreserved Leukopaks - Adult Peripheral Blood
- URL: https://www.organabio.com/product/leukopak-frzn/
- SKU: LKP-PB-004
- Category: Leukopak Apheresis-Derived Products
- Description: Cryopreserved leukopaks from adult peripheral blood for CAR-T, cell therapy, and gene therapy research. Applications include immuno-oncology, vaccine development, cell therapy development, and functional immune cell profiling. Collected under IRB-approved protocols with Certificate of Analysis provided. Available in research-grade and GMP-compliant formats.

### LeukoPAK-FRSH - Derived From Healthy Adult Peripheral Blood
- URL: https://www.organabio.com/product/leukopak-frsh/
- SKU: LKP-PB-001
- Category: Leukopak Apheresis-Derived Products
- Description: Fresh leukopaks derived from healthy adult peripheral blood for CAR-T, cell therapy, and gene therapy starting material. Applications include immuno-oncology research, vaccine development, cell therapy development, and functional immune cell profiling. Collected under IRB-approved protocols with FDA 21 CFR 1271 donor screening. Certificate of Analysis provided with each lot. Available in research-grade and GMP-compliant formats.

### ImmunoPAC™-T-CB - Cryopreserved Cord Blood-Derived Pan-T Cells (CD3⁺)
- URL: https://www.organabio.com/product/immunopac-t-cb/
- SKU: T-CB-002
- Category: ImmunoPAC™ Cord Blood-Derived Immune Cells
- Description: High-purity cryopreserved cord blood-derived pan T cells (CD3+) from single donors. Naïve T cell-enriched profile ideal for CAR-T development, allogeneic therapy, and immunology research. Consistent quality with validated QC and comprehensive donor data.

### ImmunoPAC™-NK-CB - Cryopreserved Cord Blood NK Cells (CD56⁺)
- URL: https://www.organabio.com/product/immunopac-nk-cb/
- SKU: NK-CB-002
- Category: ImmunoPAC™ Cord Blood-Derived Immune Cells
- Description: Cryopreserved cord blood-derived CD56+ natural killer cells for NK cell therapy development, immuno-oncology research, and cytotoxicity assays. Consistent quality with validated QC ensuring reliable viability and purity across lots.

### HematoPAC™-HSC-CB - Cryopreserved Cord Blood–Derived CD34⁺ Hematopoietic Stem Cells
- URL: https://www.organabio.com/product/hematopac-hsc-cb/
- SKU: HSC-CB-001
- Category: HematoPAC™ HSCs and Cord Blood
- Description: Cryopreserved cord blood-derived CD34+ hematopoietic stem cells for hematopoietic stem cell research, engraftment studies, and gene therapy development. Robust starting material with high purity and validated post-thaw viability.

### HematoPAC™-CB-FRSH - Cord Blood
- URL: https://www.organabio.com/product/hematopac-cb-frsh/
- SKU: CBU-CB-001
- Category: HematoPAC™ HSCs and Cord Blood
- Description: Freshly collected umbilical cord blood units for hematopoietic stem cell research, cord blood banking, and gene therapy applications. Processed under 24 hours from collection with comprehensive donor screening and full QC documentation.

## Product Categories
- [HematoPAC™ HSCs and Cord Blood](https://www.organabio.com/product-category/hematopac-hscs-cord-blood/): OrganaBio’s HematoPAC™ HSCs and cord blood products are specifically designed for next-generation cell therapy development. Cord blood units are collected immediately after birth from consenting healt
- [ImmunoPAC™ Cord Blood-Derived Immune Cells](https://www.organabio.com/product-category/isolated-immune-cells/)
- [Leukopak Apheresis-Derived Products](https://www.organabio.com/product-category/leukopak-apheresis-derived-products/): Utilizing apheresis materials is simplified with OrganaBio’s Leukopak portfolio of products, which includes RUO and GMP grades, fresh and frozen leukopaks, and isolated cells. PBMCs, T cells, and NK c
- [MesenPAC™ MSCs](https://www.organabio.com/product-category/mesenchymal-stromal-cells-media/)

## Blog Posts & Articles
- [What Is a Leukopak and How Do You Source Quality Material for Cell Therapy?](https://www.organabio.com/what-is-a-leukopak-and-how-do-you-source-quality-material-for-cell-therapy/) (2026-02-26): A leukopak is a concentrated collection of white blood cells obtained through apheresis — a process that separates specific blood components from a donor and returns the rest. For cell and gene therap
- [Breaking the Healthy Donor Paradigm: Why Lupus Patients Are Revolutionizing Cell Therapy Development](https://www.organabio.com/breaking-the-healthy-donor-paradigm-why-lupus-patients-are-revolutionizing-cell-therapy-development/) (2025-12-09): The Uncomfortable Truth About Your “Perfect” Healthy Donors Here’s a question that should keep every cell therapy developer awake at night: Why are you developing therapies for sick patients using cel
- [The Real Cost Per Usable Cell: Building a Scientist – Friendly TCO Model](https://www.organabio.com/the-real-cost-per-usable-cell-building-a-scientist-friendly-tco-model/) (2025-12-03): Why scientists need a procurement model If you can’t explain total cost of ownership (TCO) in lab terms, procurement will do it for you – poorly. For leukopaks and PBMC work, the cheapest unit price c
- [PBMC Thaw and Recovery: The Small Moves That Change Your Data](https://www.organabio.com/pbmc-thaw-and-recovery-the-small-moves-that-change-your-data/) (2025-11-18): Teams will optimize PBMC isolation for weeks and then improvise the samples thaw process. That’s backwards. Thaw is where you either protect what you banked or waste it. A tight thaw SOP pays off in h
- [What “<30 Minutes to Process” Actually Changes in Clinical Cell Handling](https://www.organabio.com/what/) (2025-11-12): Why minutes matter in Clinical Cell Handling Time between sample collection and the first isolation step isn’t just logistics: it’s biology. The shorter and more consistent that window, the more predi
- [Successful Cord Blood CD34+ HSC Isolation Determinants: Quality, Quantity, and Timing.](https://www.organabio.com/successful-cord-blood-cd34-hsc-isolation-determinants-quality-quantity-and-timing/) (2025-10-09): Cord blood is a rich source of hematopoietic stem cells (HSCs), which are immature cells that can develop into all types of blood cells. This makes HSC-rich umbilical cord blood an ideal starting mate
- [You Need Access to a Robust and Reliable Donor Pool](https://www.organabio.com/you-need-access-to-a-robust-and-reliable-donor-pool/) (2025-10-07): De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool When cell and gene therapy researchers step into the lab each morning, we envis
- [The Industry Needs Scalable Solutions for Biopharmaceutical Companies and Clinical Trial Sponsors](https://www.organabio.com/the-industry-needs-scalable-solutions-for-biopharmaceutical-companies-and-clinical-trial-sponsors/) (2025-09-23): Critical Gaps in Sample Processing Capabilities are Hindering Clinical Trial Advancement With the global Coronavirus disease 2019 (COVID-19) pandemic and the resurgence of other viral infections such 
- [The OrganaBio cGMP Manufacturing Facility (Miami, FL) – Manufacturing with Clinical Translation in Mind](https://www.organabio.com/the-organabio-cgmp-manufacturing-facility/) (2025-09-15): OrganaBio cGMP manufacturing facility in Miami, FL provides clinical translation of CAR T, gene therapy, and advanced cell therapies with HLA typed materials. Current good manufacturing practice (cGMP
- [From Research to Clinical Trials to Commercialization: Advancing CGT with Frozen Cellular Starting Materials](https://www.organabio.com/from-research-to-clinical-trials-to-commercialization-advancing-cgt-with-frozen-cellular-starting-materials/) (2025-01-30): Although using fresh donor cells may seem cost-effective during the early stages of cell and gene therapy (CGT) development, relying on them can create significant hurdles as programs progress toward 
- [Cryopreservation: Freezing Time in Cell and Gene](https://www.organabio.com/cryopreservation-freezing-time-in-cell-and-gene/) (2024-10-24): From advanced supply chains and personalized medicines, to interplanetary exploration, cryopreservation could have a profound impact on the future of healthcare and therapeutics. Advanced therapy deve
- [The Hidden Risks of Over-Reliance on Healthy Donor Material](https://www.organabio.com/the-hidden-risks-of-over-reliance-on-healthy-donor-material/) (2024-10-10): Developing cell therapies solely with healthy donor material can jeopardise clinical outcomes, introducing risks ranging from faulty preclinical data to manufacturing failures. Drug Target Review spok
- [Agile Cell Supply and Processing to Accelerate Development of the Medicines of the Future](https://www.organabio.com/agile-cell-supply-and-processing-to-accelerate-development-of-the-medicines-of-the-future/) (2024-09-30): OrganaBio is a leading supplier in the cell and gene therapy sector, providing scalable solutions from early development through clinical stages. Since its founding in 2018, OrganaBio has been dedicat
- [CDMOs Need to Convince Customers of New Technology Benefits](https://www.organabio.com/cdmos-need-to-convince-customers-of-new-technology-benefits/) (2024-09-20): CDMOs are willing to invest in innovative bioprocessing technologies, but the economics need to make sense. Platforms that can be used for multiple projects are worth the money, but bespoke, product-s
- [The Cell Preservation Society](https://www.organabio.com/the-cell-preservation-society/) (2024-08-22): Experts discuss the trends, challenges, and advantages in cryopreservation use for cell and gene therapies in this latest Medicine Maker, The Cell Preservation Society panel. Therapy developers and re
- [Cell donors are essential for new therapies. They need to be taken care of](https://www.organabio.com/cell-donors-are-essential-for-new-therapies-they-need-to-be-taken-care-of/) (2024-08-09): Cutting-edge FDA-approved therapies made from human cells are now being used to treat cancer, diabetes, and other diseases. Currently, most approved cell-based therapies use an individual’s own cells,
- [Vector Connector](https://www.organabio.com/vector-connector/) (2024-08-09): In May 2024, the 27th Annual Meeting of the American Society of Gene and Cell Therapies (ASGCT) explored the current viral vector-based therapy landscape and the emerging vectors in the field. A panel
- [Clinical Insider: Lack of Sample Processing Capacity in Trials Sector – a Challenge for Cell Therapy Firms](https://www.organabio.com/clinical-insider-lack-of-sample-processing-capacity-in-trials-sector-a-challenge-for-cell-therapy-firms/) (2024-08-07): COVID-19 showed that while CROs can administer doses, perform leukapheresis and draw blood samples there is a lack of capacity for sample processing, cryopreservation and apheresis. And this lack of c
- [Evolution and Ethics in the Blood Industry](https://www.organabio.com/evolution-and-ethics-in-the-blood-industry/) (2024-07-26): So much of healthcare relies on blood. Whether it’s operations and procedures, tending to emergencies, or using it as a starting material for cell and gene therapies, without blood so much of the life
- [DDW Event Highlights in 2024 So Far](https://www.organabio.com/ddw-event-highlights-in-2024-so-far/) (2024-07-15): There have been a number of key events in the drug discovery community’s diary in 2024 to date, from AACR 2024 and LSX Congress 2024 to SLAS 2024 in Boston and Barcelona. Drug Discovery World reflecte
- [Pharma’s Almanac Quarterly Roundtable Questionnaire](https://www.organabio.com/pharmas-almanac-quarterly-roundtable-questionnaire-2/) (2024-07-11): In this installment of the Pharma’s Almanac quarterly roundtable questionnaire, industry experts were asked to respond to the following questions: How can life science technology providers support the
- [Priya Baraniak, Ph.D. Talks to IBTV about World Blood Donor Day](https://www.organabio.com/priya-baraniak-ph-d-talks-to-ibtv-about-world-blood-donor-day/) (2024-07-11): On World Blood Donor Day, Priya Baraniak, Ph.D., talks about the importance of blood donors and OrganaBio’s focus on ethical collection of blood and cord blood units from altruistic donors. Watch Full
- [Clinical Insider: OrganaBio Ups Cell Processing Capacity to Cater for Expanded Trial](https://www.organabio.com/clinical-insider-organabio-ups-cell-processing-capacity-to-cater-for-expanded-trial/) (2024-07-11): As reported in Clinical Insider, OrganaBio has expanded its cell processing and cryopreservation facility in Irvine, California to support cell therapy clinical trials. The Miami, Florida-headquartere
- [Fresh or Frozen? Navigating the Cryopreservation Dilemma for CGT.](https://www.organabio.com/fresh-or-frozen-navigating-the-cryopreservation-dilemma-for-cgt/) (2024-07-08): Cell and gene therapy development grapples with a paradox: fresh starting material is often equated with higher-quality drug products, but cryopreservation is crucial for scale-up. In fact, every appr
- [Optimizing Clinical Research Outcomes through a Distributed Cell Processing and Cryopreservation Network for Clinical Sample Processing – ISCT 2024 Poster](https://www.organabio.com/optimizing-clinical-research-outcomes-through-a-distributed-cell-processing-and-cryopreservation-network-for-clinical-sample-processing-isct-2024-poster/) (2024-06-22): Sponsors conducting clinical trials require the collection of participant blood samples at specific intervals and over a rolling period, necessitating an experienced cell processing solutions provider
- [How Cell and Gene Therapies Are Infusing Blood Centers with New Purpose](https://www.organabio.com/how-cell-and-gene-therapies-are-infusing-blood-centers-with-new-purpose/) (2024-04-15): Facing infrastructure roadblocks, the cell and gene industry has found a potential solution in an unexpected place: blood donation centers. “Part of where blood centres or not-for-profit organisations
- [Pharma’s Almanac Quarterly Roundtable Questionnaire](https://www.organabio.com/pharmas-almanac-quarterly-roundtable-questionnaire/) (2024-04-15): In this installment of the Pharma’s Almanac quarterly roundtable questionnaire, industry experts were asked to respond to the following questions: Environmental, social, and governance (ESG) criteria 
- [Decentralizing Cryopreservation to Improve Cell and Gene Therapy Trial Logistics](https://www.organabio.com/decentralizing-cryopreservation-to-improve-cell-and-gene-therapy-trial-logistics/) (2024-04-10): As the cell and gene therapy (CGT) pipeline continues to grow, clinical trial sites need to use better technology and increase their capacity to run more complex trials. Some sites do not have the fun
- [Strategies for Early-Stage Startups in the Biotech Industry](https://www.organabio.com/strategies-for-early-stage-start-ups-in-the-biotech-industry/) (2024-04-09): In a Building Biotechs podcast by Recruitomics, OrganaBio’s Chief Business Officer, Priya Baraniak, Ph.D. speaks about the hurdles and potential of early-stage biotech startups, as well as her persona
- [How are birth tissue donations fueling the cell therapy revolution?](https://www.organabio.com/how-birth-tissue-donations-are-fuelling-the-cell-therapy-revolution/) (2024-04-09): Listen to pharmaphorum’s podcast on birth tissue donations and how and why these biological materials are so valuable. Priya Baraniak, Ph.D. discusses some of the issues around birth tissue collection
- [2024 Pharma Predictions: Regulations, Sustainability and Culture.](https://www.organabio.com/2024-pharma-predictions-regulations-sustainability-and-culture/) (2024-04-09): Pharma Manufacturing asked leaders, including OrganaBio’s Chief Business Officer, Priya Baraniak, PhD, to weigh in on what the pharma industry can expect in the coming year: “2024 will undoubtedly see
- [Miltenyi Biotec Stories: OrganaBio.](https://www.organabio.com/miltenyi-biotec-stories-organabio/) (2024-04-05): Step inside the company’s Miami facilities and hear about their vision to serve as the premier choice for cell and gene therapy developers. Listen in as OrganaBio Chief Business Officer Priya Baraniak
- [Cryopreservation for Critical Starting Material Products: Benefits of Effective Cold Chain Management.](https://www.organabio.com/cryopreservation-for-critical-starting-material-products-benefits-of-effective-cold-chain-management/) (2024-03-09): Advanced cell-based therapies, such as chimeric antigen receptor (CAR)-T cell therapies, are changing the landscape of healthcare, expanding treatment options for patients beyond previous standards of
- [Case Study: OrganaBio’s Hub Processing Model.](https://www.organabio.com/case-study-organabios-hub-processing-model/) (2024-02-22): This case study examines how OrganaBio’s unique Hub Processing Model successfully addressed the critical needs of two multinational pharmaceutical companies conducting mRNA vaccine trials for COVID-19
- [Watch: Bullpen | Justin Irizzary | JPM 2024](https://www.organabio.com/watch-bullpen-justin-irizarry-jpm-2024/) (2024-02-22): Justin Irizarry, OrganaBio’s CEO, is interviewed in the Bullpen by Jacques Jospitre of SohoMD. Learn about OrganaBio’s unique vertically integrated business model, wholly-owned supply chains of adult 
- [Getting Off to a Good Start](https://www.organabio.com/getting-off-to-a-good-start/) (2024-02-16): Why finding high-quality donor cells is so important in cell therapy development? Key Challenges: Variability in donors: Human cells naturally vary, creating challenges in standardizing therapies and 
- [WATCH: Cell and Gene Therapy Manufacturing Panel at ATW 2024](https://www.organabio.com/watch-cell-and-gene-therapy-manufacturing-panel-at-advanced-therapies-week-2024/) (2024-02-09): At Advanced Therapies Week 2024 in Miami, Isabel Cameron hosted a roundtable discussion to discuss all things cell and gene therapy manufacturing. Watch OrganaBio’s Chief Business Officer, Priya Baran
- [What challenges does the advanced therapies sector face?](https://www.organabio.com/what-challenges-does-the-advanced-therapies-sector-face/) (2024-02-05): Over the three days of Advanced Therapies Week (ATW) 2024 in Miami, Florida, US, 16-19 January 2024, Drug Discovery World’s Megan Thomas heard from attendees about the obstacles the sector needs to ov
- [Catch a Glimpse of OrganaBio at ISCT 2023](https://www.organabio.com/catch-a-glimpse-of-organabio-at-isct2023/) (2023-06-05): Watch a short clip of OrganaBio’s Chief Business Officer, Priya Baraniak, Ph.D. and VP, Operations, J. Dominic Mancini #LiveWithChaudhrey at #ISCT2023 Paris (June 1, Day 2) to learn about OrganaBio, o
- [Case Study: Delivering RUO and GMP Leukopaks to Singapore.](https://www.organabio.com/case-study-leukopac-collections-to-singapore/) (2023-04-03): INTRODUCTION The monoclonal antibodies (mAbs) daratumumab, and elotuzumab have been approved by the US Food and Drug Administration for treating multiple myeloma (MM) in 2015. Although clinical respon
- [The OrganaBio Method for Cultivation of a Highly Recallable Leukapheresis Donor Pool](https://www.organabio.com/the-organabio-method-for-cultivation-of-a-highly-recallable-leukapheresis-donor-pool/) (2023-04-03): OrganaBio and its wholly-owned leukapheresis collection subsidiary, HemaCenter, have designed processes and procedures to curate and maintain a highly recallable donor pool. Access to robust, reliable
- [Know More About HLA Typing](https://www.organabio.com/know-more-about-hla-typing/) (2022-09-23): While Human Leukocyte Antigen (HLA) matching is often emphasized in the context of bone marrow and organ transplant, HLA typing is used to identify disease-related biomarkers and predict immune respon
- [NK Cells: Born to Kill](https://www.organabio.com/nk-cells-born-to-kill/) (2022-09-22): Natural Killer (NK) cells have been considered a part of the innate immune system due to their lack of antigen specific receptors. Unlike other lymphocytes that develop in the bone marrow from lymphoi
- [Wait a Minute: The Ethics of Cord Blood Collection](https://www.organabio.com/wait-a-minute-the-ethics-of-cord-blood-collection/) (2022-08-01): Delayed umbilical cord clamping has a variety of benefits for newborns and is the current standard of care at the time of delivery. Does your cord blood collection agency adhere to these medical and e
- [Could Immune Cell Derived Exosomes Be A Cell-free Immunotherapy Alternative?](https://www.organabio.com/could-immune-cell-derived-exosomes-be-a-cell-free-immunotherapy-alternative/) (2021-06-14): Extracellular vesicles (EVs) are nanometer-scale, lipid bilayer enclosed structures that are secreted by cells. EVs elicit complex signaling functions in other cells that encounter these vesicles. EVs
- [Know Your HLA](https://www.organabio.com/know-your-hla/) (2021-05-18): What do a woman suffering from Psoriasis, a man dying after acute rejection of kidney transplant, and a child suffering from Pulmonary Tuberculosis due to susceptibility to mycobacteria infection all 
- [Transforming a World of Research into a World of Cellular Therapies](https://www.organabio.com/organabio-overview-transforming-a-world-of-research-into-a-world-of-cellular-therapies/) (2021-04-13): In this presentation, OrganaBio’s CEO, Justin Irizarry, gives an overview of OrganaBio’s capabilities and how they can be leveraged to support the development and commercialization of cutting-edge cel
- [A Comparison of Lymphocytes from Adult Peripheral Blood versus Umbilical Cord Blood](https://www.organabio.com/a-comparison-of-lymphocytes-from-adult-peripheral-blood-versus-umbilical-cord-blood/) (2021-03-22): With the rapid advancement of cell therapies, there is a demand for cellular starting materials that are robust, reproducible, well-characterized, and clinically relevant. Many adoptive cell therapies
- [MSC-omics: The Next Frontier for MSC Characterization and Standardization](https://www.organabio.com/msc-omics-the-next-frontier-for-msc-characterization-and-standardization/) (2021-02-09): Mesenchymal stem/stromal cells (MSCs) are multipotent progenitor cells that possess robust anti-inflammatory and immunomodulatory properties. Due to their apparent safety and their ability to secrete 
- [The Story of T Lymphocytes](https://www.organabio.com/the-story-of-t-lymphocytes/) (2021-01-11): Some say that CAR-T (Chimeric Antigen Receptor T cell) revolutionized cell therapy and transformed the manufacturing technologies of the industry. Following the approval and success of the CD19 CAR-T,
- [Perinatal Tissues Are a Rich Source of Progenitor and Immune Cells](https://www.organabio.com/perinatal-tissues-are-a-rich-source-of-progenitor-and-immune-cells/) (2020-11-30): Over the last several years, the field of cell therapy has rapidly advanced and became a promising strategy to combat disease. The cell therapy global market is expected to reach $20B by 2023.1 Immune
- [Immune Cell-Based Therapies for COVID-19 (November 2020 update)](https://www.organabio.com/immune-cell-based-therapies-for-covid-19-november-2020-update/) (2020-11-04): In late August, we reported about the clinical trial landscape utilizing immune cell-based therapies for COVID-19. The original search revealed 15 total relevant trials, out of which 6 were registered
- [MSC-Based Therapies for COVID-19 (October 2020 update)](https://www.organabio.com/msc-based-therapies-for-covid-19-october-2020-update/) (2020-10-30): At the beginning of August, we searched the clinicaltrials.gov database to learn more about the U.S.-based clinical trial landscape of mesenchymal stromal cell (MSC) based therapies for COVID-19. The 
- [Developing a Robust CGT Manufacturing Process](https://www.organabio.com/developing-a-robust-cgt-manufacturing-process/) (2020-10-28): In this presentation, OrganaBio’s Head of Process & Product Development highlights our approach to setting the stage early in process development for sustained manufacturing success. This talk was ori
- [A Brief Introduction to Immunology](https://www.organabio.com/a-brief-introduction-to-immunology/) (2020-09-21): Breakthroughs in immunotherapy, such as chimeric antigen receptor T cell (CAR-T) therapy and checkpoint inhibition antibodies, have led to a rejuvenated interest in the human immune system. Insights f
- [Simple Science: Cardiac RegenMed](https://www.organabio.com/simple-science-cardiac-regenmed/) (2020-09-01): Simple Science: Cardiac Regenerative Medicine The field of cardiac regenerative medicine is rapidly developing solutions to treat the millions of people around the world affected by cardiac illnesses.
- [Immune Cell-Based Therapies for COVID-19](https://www.organabio.com/immune-cell-based-therapies-for-covid-19/) (2020-08-20): Immune Cell-based Therapies for COVID-19: Current Clinical Trial Landscape Data One element of COVID-19 is a hyper-response of the patient’s immune system, which in turn leads to lung injury and acute
- [MSC-Based Therapies for COVID-19](https://www.organabio.com/msc-based-therapies-for-covid-19/) (2020-08-11): MSC-Based Therapies for COVID-19: Current Clinical Trial Landscape Data Mesenchymal stem/stromal cells (MSCs) are emerging as a potential treatment modality for COVID-191-3. MSCs have immunomodulatory
- [Cell Therapy for COVID-19](https://www.organabio.com/cell-therapy-for-covid-19/) (2020-08-03): In late 2019, cases of Coronavirus Disease 2019 (COVID-19) began to emerge out of Wuhan, China. Since then, the disease has proven to be highly contagious and has rapidly spread around the world, beco
- [Who We Are](https://www.organabio.com/who-we-are/) (2020-05-22): OrganaBio was founded in 2018 by scientists and business leaders motivated to bring next generation regenerative medicine therapies to market. Since then, we have assembled a team of 16 industry veter
- [Why We Do It](https://www.organabio.com/why-we-do-it/) (2020-05-21): At OrganaBio, we believe that nothing truly worthwhile is easy…. But we can make it easier for our partners and customers. That’s why we set out to take on a significant challenge – to alleviate bottl

## Services
- **Cell Therapy Starting Materials**: Fresh and cryopreserved leukopaks, PBMCs, NK cells, T cells, HSCs, MSCs from ethically sourced birth tissues and adult leukapheresis
- **cGMP Manufacturing**: FDA-registered facilities for clinical-grade cellular starting materials with full regulatory documentation
- **Process Development**: Cell isolation, expansion, characterization, and custom scale-up solutions
- **Clinical Trial Support**: Sample processing, cryopreservation, storage, and management through CPC Services subsidiary
- **Analytical Testing**: Assay development, immunophenotyping, HLA genotyping, and quality control testing

## Contact
- Website: https://www.organabio.com
- Contact page: https://www.organabio.com/contact/

## Optional
- [Sitemap index](https://www.organabio.com/sitemap_index.xml)
- [FAQ](https://www.organabio.com/frequently-asked-questions/)