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OrganaBio Leukopak Featured

What Is a Leukopak and How Do You Source Quality Material for Cell Therapy?

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 therapy programs, leukopaks serve as the starting material for isolating PBMCs (peripheral blood mononuclear cells), which are then used to manufacture CAR-T therapies, TCR therapies, NK cell products, and other advanced treatments.

The quality of your leukopak directly impacts downstream manufacturing success. Poor donor screening, inconsistent collection protocols, or inadequate processing leads to low cell yields, failed expansions, and wasted time in research or clinical timelines.

Whether you are developing an autologous therapy or scaling an allogeneic program, understanding what makes a leukopak suitable for your work matters from day one. This guide covers what leukopaks contain, how they are collected, what quality factors to evaluate, and how to source material that supports reliable outcomes. If you are ready to discuss your requirements, contact OrganaBio here.

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What Is in a Leukopak?

A leukopak contains a mixture of white blood cells collected from a single donor during a leukapheresis session. The apheresis process enriches for the following cell populations:

  • Lymphocytes — including T cells, B cells, and NK cells
  • Monocytes
  • Granulocytes — present in smaller amounts, depending on collection settings
  • Platelets — variable depending on apheresis parameters
  • Plasma — trace amounts, though additional plasma can be collected in the same bag

The exact composition depends on the donor’s health status, apheresis device settings, and whether mobilization agents like G-CSF were used. Most leukopaks used in cell therapy manufacturing come from non-mobilized donors, meaning the cells reflect normal circulating levels.

Typical leukopak units contain approximately 10 billion total nucleated cells (1×109). PBMC yield after processing usually ranges from 7 to 8 billion cells, depending on donor variability and isolation method.

Why Use Leukopaks Instead of Whole Blood?

Whole blood can be used to isolate PBMCs, but leukopaks offer significant advantages for therapy development and manufacturing at scale.

Higher cell yield per collection

You can expect approximately 1 million (1×106) PBMCs per mL of whole blood. To match the yield of a single leukopak, you would need to collect and process over 7,000 mL of whole blood. Leukopaks reduce the number of donors required and simplify logistics.

Consistent starting material

Apheresis standardizes collection parameters across donors, reducing variability in downstream processing. Whole blood introduces more variation in anticoagulant ratios, storage time, and handling conditions.

Better cell viability

Leukopaks are processed immediately after collection and cryopreserved under controlled conditions. Whole blood often sits longer before processing, which can negatively impact cell health and viability.

Logistical efficiency

Working with a single leukopak unit instead of coordinating multiple blood tubes simplifies workflows and reduces contamination risk — a meaningful operational advantage for manufacturing teams.

Leukopaks are the standard starting material for most cell therapy programs because they deliver predictable quality at scale.

How Are Leukopaks Collected?

Leukopak collection happens through leukapheresis. The donor sits for 2 to 4 hours while blood is drawn from one arm, processed through an apheresis machine, and returned through the other arm. The machine uses centrifugal force to separate blood into layers based on density. White blood cells are collected into a sterile bag while red blood cells, plasma, and most platelets are returned to the donor.

Donors are screened before collection to confirm they meet health and eligibility standards. Screening typically includes:

  • Physical exam and medical history review
  • Infectious disease testing — HIV, HBV, HCV, syphilis, HTLV, and others as required
  • Complete blood count to confirm adequate white blood cell levels
  • Consent and eligibility verification under IRB-approved protocols

After collection, the leukopak is either used fresh or cryopreserved in controlled-rate freezers and stored in liquid nitrogen vapor phase for long-term use.

Fresh vs. Frozen Leukopaks: Which Is Right for Your Program?

Both fresh and frozen leukopaks are used in cell therapy, and each has trade-offs.

Fresh leukopaks

Processed within 24 to 48 hours of collection. Fresh material offers higher initial viability and is often preferred for autologous therapies where the patient’s cells are collected and manufactured quickly. Avoiding freeze-thaw stress preserves certain sensitive cell populations.

Frozen leukopaks

Cryopreserved shortly after collection and storable for years. Freezing allows for batch consistency in process development, flexible scheduling of manufacturing runs, centralized inventory management, and easier logistics across multiple sites. Post-thaw viability is typically greater than 90% with proper cryopreservation protocols.

OrganaBio provides both fresh and frozen leukopaks with documented processing timelines, cryopreservation methods, and post-thaw viability data. Explore our leukopak products to find the format that fits your program.

What to Look for When Sourcing Leukopaks

Not all leukopaks are equivalent. Quality depends on donor health, collection procedures, processing speed, and supplier documentation. Evaluate suppliers on the following criteria:

Donor screening standards

Verify that donors are screened for infectious diseases according to FDA regulations and industry standards. Every unit should include test results, collection dates, and eligibility confirmations.

Collection and processing SOPs

Leukopaks should be collected under standardized protocols with trained operators and calibrated equipment. Processing delays and variability in apheresis settings directly affect cell quality.

Cell count and viability guarantees

Suppliers should provide total nucleated cell counts and viability percentages at the time of collection and after thaw. Post-thaw viability should consistently exceed 90%.

Cryopreservation methods

Frozen leukopaks should be cryopreserved with appropriate media using controlled-rate freezing and stored in liquid nitrogen vapor phase. Rapid freezing or inadequate storage conditions reduce cell recovery.

Ethical sourcing practices

Donors should provide informed consent with adequate time between donations for cellular reconstitution. Ethical sourcing is not just a regulatory requirement — properly consented and well-managed donors produce better material.

Lot-to-lot documentation

Each leukopak should come with a Certificate of Analysis (CoA) that includes donor demographics, test results, processing details, and storage conditions. This documentation supports regulatory filings and manufacturing consistency.

Custom donor matching capabilities

If your program requires specific donor characteristics — age, gender, HLA type, CMV status, disease state — confirm that the supplier can source matched material without excessive lead times. OrganaBio offers custom donor matching across hundreds of characterized, recallable donors.

OrganaBio operates an FDA-registered donor center and follows standardized SOPs across all collections. Every leukopak ships with full CoA documentation, infectious disease testing results, and ethically sourced donor consent.

Common Leukopak Quality Issues and How to Avoid Them

Low PBMC yield after processing

Caused by poor apheresis settings, donor health issues, or processing delays. Work with suppliers who provide guaranteed cell counts and who process samples as close to collection as possible.

High granulocyte contamination

Some leukopaks contain excessive granulocytes, which interfere with PBMC isolation and downstream assays. Verify that the supplier sets appropriate collection thresholds and uses proper density gradient separation methods.

Poor post-thaw viability

Viability consistently below 85 to 90% indicates suboptimal cryopreservation. Request historical viability data and test thaws before committing to large orders.

Inconsistent donor screening

Missing or incomplete infectious disease testing creates compliance risks. Every unit should include full test results and regulatory documentation. Consider screening donor whole blood before a full leukopak collection to confirm suitability.

Lack of traceability

Leukopaks without chain-of-custody records or complete consent documentation create issues during audits and regulatory reviews. Suppliers should provide unique lot numbers and traceable records for every unit.

How OrganaBio Supports Leukopak Sourcing

OrganaBio specializes in ethically sourced leukopaks for cell and gene therapy research, process development, and clinical manufacturing. With hundreds of highly characterized and recallable donors, we give researchers and therapeutic developers the ability to select material based on demographics including age, sex, BMI, blood type, smoking status, race, ethnicity, HLA type, and immunophenotype. View our full leukopak product catalog.

Our leukopak offerings include:

  • Standard inventory leukopaks. Fresh or frozen units available for immediate shipment with full documentation and infectious disease testing.
  • Custom donor matching. Donors selected based on your specifications: age, gender, HLA type (Class I and II), CMV status, disease state, or other criteria relevant to your program.
  • High-volume supply agreements. Consistent sourcing for allogeneic programs or large-scale research studies with locked-in quality standards.
  • CPC services for sample processing. If you need leukopaks processed into PBMCs, sorted populations, or other formats, we provide processing under controlled SOPs with trained operators.

Learn more about our Cell Processing and Cryopreservation Services, cGMP Manufacturing, and Assay Development and Analytical Testing capabilities.

When to Use Leukopaks in Your Cell Therapy Program

Leukopaks are appropriate for most cell therapy applications, including:

  • CAR-T and TCR therapy development and manufacturing
  • NK cell product research and production
  • Process development and optimization studies
  • Assay validation and quality control testing
  • Allogeneic donor cell banking
  • T cell expansion and engineering protocols

If your program requires consistent, high-quality starting material with full traceability, leukopaks are the industry standard.

Your Starting Material Determines Your Success

Sourcing leukopaks is a foundational decision in cell therapy development. Quality, consistency, and supplier reliability determine whether your downstream processes succeed or stall.

If you are evaluating leukopak suppliers or need custom donor matching for an allogeneic program, OrganaBio can help. We provide ethically sourced material with transparent documentation and flexible sourcing options tailored to your timeline and specifications. Contact OrganaBio to discuss your requirements or request a quote.

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Andrew Larson

Managing Director, CPC Services

Andrew joins OrganaBio as a project manager with varied experience in project management, client relations, and process improvement.

Prior to OrganaBio, Andrew was a client relations manager for the cGMP nucleic acids business unit at Aldevron, coordinating and managing contracts at each stage of the contract lifecycle in support of cell and gene therapy program development. Andrew supported small- and large-scale biotechnology and pharmaceutical clients anywhere from pre-IND work through commercial supply chain establishment. Before Aldevron, Andrew was a project manager for the commercialization and business development department for Sanford Health, a worldwide hospital institution. At Sanford Health, Andrew helped manage medical device patent and prototype development efforts for employee innovations primarily in the cardiovascular, neurovascular, and software spaces. Andrew was also an engineer for Atirix Medical Systems and supported the buildout of automated analysis worksheets to streamline radiology department quality control procedures.

Andrew received his Bachelor of Science in Physics from Minnesota State University Moorhead and his Master of Science in Biomedical Engineering from the University of Minnesota. At the University of Minnesota, Andrew was part of the Center for Magnetic Resonance Research, assisting efforts to automate MRI dataset registration and workflow improvement.

Michael Dee

Associate Director, QC and Analytical Development

Michael Dee has spent the last 17 years researching the immune system. Initially studying the recombinant cytokine IL-2 and its role in T cell subset differentiation and function at the University of Miami. He also helped elucidate the lower level of TCR diversity of T regs required to prevent autoimmunity in mice. Michael also supported construction, cloning, production, purification, and testing both in vitro and in vivo a novel IL-2/IL2Rα complex currently under clinical development with BMS. Michael also was a member of the department of immunology’s program project delineating the effect of a novel Eg7GP96 heat shock protein vaccine on tumor immunity.

While at Immunity Bio (formerly Altor Biosciences), he helped to characterize over 20 novel drugs for immune modulation and treatment of cancer.  After Immunity Bio, Michael was a founding team member of HCW Biologics, where he continued his role in design and initial production and characterization of several novel biologics. He has experience with proof of principle experiments with the generation CAR-NK and CAR T cells. His research at HCW was highlighted by his discovery of a process using novel biologics to activate and expand CIML NK cells. The process and rights were sold to Wugen and is currently in Phase I clinical trials. He also is listed as an Inventor on patent number: US20210268022A1 on method of activating regulatory T cells.

Meram Alamoudi

Senior Cell Processing Specialist

Meram received her master’s degree in biomedical sciences from Barry University and bachelor’s in Biology from Palm Beach Atlantic University.

Before her position at OrganaBio, Meram conducted research at Larkin University where she worked on assessing the impact of Hurricane Maria on respiratory diseases in Puerto Rico, which provided her with insight into research investigation and analysis along with generation of grant documentation.

Valeria Beckhoff-Ferrero

Senior Bioprocess Scientist

Valeria Beckhoff Ferrero has over 8 years of experience in the fields of stem cell research and tissue engineering. Valeria received her Bachelor of Science in Biomedical Engineering, specializing in Biomaterials and Tissue Engineering, from Drexel University in Philadelphia. Valeria has expertise in problem solving and finding manufacturing solutions for isolating various types stem cells and other cell derived products from different tissues.

Before joining OrganaBio, Valeria was a lead manufacturing engineer at the Amnion Foundation. She aided in instituting a GMP infrastructure, including documentation, to manufacture clinical grade placental derived stem cells. In her role, she worked in perfecting isolation, culture, selection and cell maintenance processes for perinatal derived stem cells.

Valeria’s experience includes working as an Automation Engineer at the New York Stem Cell Foundation, where she aided in the creation and coding procedures for liquid handlers to manufacture induced pluripotent stem cells. At NYSF, Valeria researched new methods of sorting, reprogramming and differentiating iPSCs.

During her studies, Valeria worked at Thomas Jefferson University Hospital’s Radiation Oncology department, where she engineered various devices to aid in hyperthermia treatments. Additionally, Valeria co-authored multiple publications on magnetic resonance guided focused ultrasound and radiation antennas for hyperthermia treatments.

Marisa Reinoso

Director, Regional Scientific Sales

Marisa has experience leading marketing and sales life sciences programs for over a decade. Originally a lab researcher, she made the jump to marketing & sales in life sciences and never looked back.

At OrganaBio, she connects cell therapy developers on the West coast and in Asia with the healthy donor starting materials they need to develop their therapies. Prior to OrganaBio, she was the cell therapy marketing lead at Invetech, heading the launch of the company’s first cell therapy product. Marisa has led marketing programs at clinical supply companies Sherpa Clinical Packaging and PCI Pharma Services. In her spare time, Marisa enjoys traveling, eating, and pretending she’s a tennis player. She has a Bachelor of Arts in Biology from Reed College and an MBA from Portland State University.

Thelma Cela

Senior Director, Tissue Procurement

Thelma Cela is a top performing professional with over 25 years’ experience in management, leadership, business development and marketing fields with business acumen and skills in driving revenue and profit growth in multiple corporate cultures. Prior to joining OrganaBio, Thelma served as Senior Director for Health and Human Services for the Seminole Tribe of Florida. Her role had oversight for health clinics, health plan administration, the behavioral health department, and elder services. In this governmental administrative capacity, Thelma had primarily responsibility for the HHS’ divisions’ budget, capital projects, utilization management, efficiency, and efficacy.

Thelma’s prior work experiences include Vice President of Clinical Operations for OrthoNOW. In this role, she provided guidance on all clinical matters, set direction on clinical policies and procedures and monitoring healthcare policy changes. As the national Vice President of Clinical Operations, Thelma also designed, developed, and implemented guidelines and protocols and ensured compliance regarding overall patient experience.

Before joining OrthoNOW, Thelma had been recruited by Leon Medical Centers, a private healthcare company operating comprehensive medical centers to launch a new business line addressing the health and wellness of an aging population. As Director, Thelma researched, created, and launched the company’s Health Living Centers which provided first of its kind facilities in the South Florida market to offer services to the community of health aging.

Thelma has a proven track record in multiple corporate healthcare cultures having worked for Mercy Hospital where she was Senior Program Director of their Diabetes Treatment Center and Director of their Surgical Weight Loss Program. She enhanced these service lines awareness in the community, improved both lines’ clinical outcomes, and built volume growth while maintaining ongoing physician support. She served in a similar capacity for American Healthways.

Thelma earned her MBA from Miami Regional University where she graduated Cum Laude and her undergraduate degree in Psychology is from the University of Miami.

She serves on the advisory panel for Florida International University’s Women in Business Leadership Program helping future women become future business leaders through thought leadership, barrier destruction, and the power of influence.

Dominic Mancini

Vice President, Operations

Dominic Mancini brings 12 years of experience working the interfaces between Analytical Development, Process Development, Quality, and Manufacturing Science to OrganaBio. A lifelong learner, Dominic enjoys solving the many scientific and operational challenges presented in the field of cell and gene therapy.

Prior to OrganaBio, Dominic spent 8 years at Bluebird Bio as the company grew from 45 to 1200+ employees and from 1 clinical asset to a robust commercial pipeline. At Bluebird, Dominic initially supported the development and technology transfer of lentiviral vector manufacturing processes. As demand grew for lentiviral process and product characterization, Dominic led the development, qualification, transfer, and validation two commercial release methods. Dominic transitioned back to the Process Development organization to lead the vector manufacturing core team, increasing operational efficiency through a 5S implementation, process schedule intensification, and reverse technology transfer initiative. More recently, Dominic supported the build-out of bluebird’s Manufacturing Science & Technology team followed by the Data Systems & Analytics team, handling late-stage commercial asset support.

Dominic received his Bachelor of Chemical Engineering with Distinction from the University of Delaware. Dominic’s undergraduate research culminated in his thesis on heterologous expression of G-protein coupled receptors in Saccharomyces cerevisiae. After graduation, Dominic was the premier hire of the Zhou Laboratory at Brigham and Women’s hospital in Boston, MA. In three years, Dominic established an animal model of COPD and co-authored several papers with his collaborators in the Pulmonary division.

Christopher B. Goodman

Vice President, Quality & Regulatory Affairs

Christopher B. Goodman is a biopharmaceutical consultant and executive making a global impact in the cellular therapy technology arena. The scope of Christopher’s expertise encompasses Cellular Therapeutic Operations, Quality and Regulatory Affairs, Global Corporate Operations, Scientific Strategic Planning, Scientific R&D Collaborations, and Marketing & Commercialization.

Christopher recently joined OrganaBio as their Vice President of Regulatory Affairs. In this role, Christopher will be helping the company, its clients and partners navigate the complexities of the domestic and international regulatory requirements governing advanced cellular therapy products and manufacturing.

Previously, Christopher held positions with the Association for the Advancement of Blood and Biotherapies (AABB), Virgin Health Bank, Ventana Medical Systems, and Celgene.

While with AABB, he held the positions of Senior Director of New Products and Lead Quality Assessor, auditing both domestic and international organizations to known standards in an effort to promote and ensure patient quality care and manufactured product consistency and standardization within Cellular Therapy, Blood Banking, Transfusion Services, Perioperative and Donor Center industries and operations. He contributed greatly to the work of AABB’s accreditation program providing his deep breadth of knowledge and technical acumen on many committees during his tenure. His pioneering work in the realm of virtual assessments during the COVID pandemic allowed AABB to flex into the planning and execution of this novel approach to the maintenance of accreditation activities during a global travel crisis. His agile thinking and approach to planning provided as minimal disruption as possible to AABB’s customer facilities.

While working with Virgin Health Bank in the State of Qatar and the United Kingdom, Christopher advanced through a series of executive roles. He joined Virgin Health Bank as the Director of Operations, during which time he managed the successful design, and build out of a new state-of-the-art cGMP facility, the first in the Middle East. As Director and Chief Executive Officer, he directed the launch of the first Arab-centric stem cell bank, and strategically guided the organization to enhanced shareholder value and expansion across the Middle East and UK. In these roles, he also oversaw global corporate operations, research collaborations, product portfolio expansion, and regulatory framework.

Christopher managed the Detection and Chemistry Assay Development Group for Ventana Medical Systems, a global leader and innovator of tissue-based diagnostic solutions. In this role, he directed overall program goals, optimized resources, and guided technical and product direction in global regulated environments.

Prior to Ventana Medical Systems, he held the position of Director of Operations for the high-growth Cellular Therapeutics Division of Celgene. As a senior-level scientist and member of the executive team, he directed divisional operations, medical affairs and executed business and scientific strategic planning.

Danielle Smyla

Senior Director, Quality Assurance

Danielle Smyla, M.S., brings 14 years of Quality Assurance and GMP experience in the Biotechnology and Medical Device industries. Ms. Smyla is an established Quality Leader with expertise in the implementation, management and continuous improvement of Quality Management Systems for GMP operations.

Prior to joining OrganaBio, Danielle was a key member of the Quality Management team at Canon BioMedical, where she led the cross-functional development and implementation of their Quality Management System. She also managed a team of Quality Specialists and Sr. Specialists, coaching them in the implementation, management and identification of improvements to quality processes.

Ms. Smyla’s Quality-focused career is complimented by valuable hands-on experience in GMP product manufacturing, as well as R&D laboratory experimentation and formulation work in support of product development.

Danielle has earned a Master’s in Biotechnology from the Johns Hopkins University and a Bachelor of Science in Chemistry from the George Washington University.

Priya Baraniak, Ph.D.

Chief Business Officer

Dr. Baraniak is a proven strategic thinker, problem solver and leader who brings 20 years of expertise in stem cells and tissue engineering, coupled with a keen business acumen, to OrganaBio. Dr. Baraniak has published multiple peer-reviewed papers and book chapters on the use of stem cells and biomaterials in cardiac repair and regeneration and is routinely invited to speak at conferences.

Before joining OrganaBio, Priya was a founding member of RoosterBio and was a vital member of the company’s Leadership Team. At RoosterBio, Priya leveraged her technical expertise to build and rapidly scale the company’s sales and marketing engines in a fast-paced start-up environment, delivering impressive growth in revenue year-over-year. Additionally, in her role as Business Development lead at RoosterBio, Priya structured, negotiated and executed multiple strategic partnerships for aggressive growth of the organization.

Priya’s industry experience includes a role as Senior Director of R&D for Garnet BioTherapeutics, a clinical-stage stem cell-based regenerative medicine company, where Priya led multiple projects on tissue repair and regeneration using mesenchymal stem cell (MSC)-based therapeutics and devices. While at Garnet Bio, Priya also worked on the company’s FDA filings, contributed to drafting and prosecuting the company’s patent portfolio, managed CRO, CMO and industry partner relationships and actively participated in establishing Garnet’s strategic R&D plan, thereby gaining critical insights into business operations across a small organization.

Priya’s scientific training began as an undergraduate student at Duke University, where she earned a Bachelor of Science in Engineering (BSE) from Duke University in 2001 after double majoring in Electrical Engineering and Biomedical Engineering. While at Duke, Priya conducted research in the lab of Dr. Doris A. Taylor on the use of skeletal myoblasts and stem cells for cardiac repair and regeneration. Priya went on to receive her Ph.D. in Bioengineering from the University of Pittsburgh in 2008. She completed her dissertation research in the laboratory of Dr. William R. Wagner working on developing a controlled release biodegradable elastomer for applications in cardiovascular regenerative medicine. In 2008, Priya joined Dr. Todd McDevitt’s lab in the Department of Biomedical Engineering at Georgia Tech and Emory University as a post-doctoral fellow. Her post-doctoral research as an American Heart Association Fellow focused on harnessing the secretome and isolating the extracellular matrix from MSCs and other cell types, including pluripotent stem cells, for cardiac tissue repair and regeneration. Priya co-authored many grants while a post-doc and went on to contribute critical sections to a NIST grant that resulted in the first ever National Cell Manufacturing Consortium in the United States.

Sarah Alter, Ph.D.

Lab Director

Sarah Alter, Ph.D., has 15 years of immunology research experience which includes autoimmunity, cancer, and infectious disease.

Before her position at OrganaBio, Sarah was responsible for leading a team of scientists at Altor Bioscience where she facilitated the advancement of Altor’s technologies. As a Research and Development Manager, Dr. Alter coordinated immunotherapy-focused preclinical and clinical studies and contributed to the progress of Altor’s drug discovery and therapeutic applications.

Sarah received her Doctor of Philosophy from the University of Miami, Miller School of Medicine. She is also a registered Patent Agent, licensed to practice before the United States Patent and Trademark Office. Her work was published in many peer-reviewed journals and presented at national and international business and scientific meetings.

Carlos Carballosa, Ph.D

Vice President, Sales

Dr. Carlos Carballosa holds a doctorate in Biomedical Engineering from the University of Miami and currently leads global sales for OrganaBio as the VP of Sales. Since joining the company in 2018, Carlos has had a hand in managing all of OrganaBio’s products and services including perinatal tissue, apheresis material, and cell processing and cryopreservation support services for clinical trials.

Oscar Robles

Director, Quality Systems

Oscar Robles has over thirty years of experience in pharmaceutical and medical device industries. His main areas of expertise are in Quality Systems, Quality Assurance, Manufacturing Systems Validation, Computerized Systems Validation, implementation of GxP Computerized Systems and ERP Systems such as TrackWise, Electronic Document Management, JDEwards, SAP, and Oracle. Prior to joining OrganaBio, Oscar was a member of the Quality Management team at Apotex – Aveva Drug Delivery Systems for ten years. Oscar has earned a Master’s in Business Administration from Nova Southeastern University and a Bachelor of Science in Electrical Engineering from Florida International University.