Cryopreserved leukopaks from disease-state donors, currently focused on systemic lupus erythematosus (SLE) with active expansion into Crohn's, ulcerative colitis, celiac disease, rheumatoid arthritis, and multiple sclerosis. Each unit delivers a full leukopak (10 billion or more cells) from a single donor, screened against 14 infectious disease markers under 21 CFR 1271, with high-resolution NGS HLA typing across HLA-A, B, C, DR, DQ, DP. Best fit: biomarker discovery, autoimmune drug screening, and cell therapy programs requiring disease-relevant immune dysregulation in vitro.
Quick Summary
Plasma collected from systemic lupus erythematosus (SLE) donors via OrganaBio's HemaCenter apheresis subsidiary (wholly owned, FDA-registered). Each donor screened against 14 infectious disease markers under 21 CFR 1271 with NGS HLA typing across six genes. Sourced from OrganaBio's qualified, recallable donor pool. Best fit: autoantibody profiling, complement and inflammatory cytokine work, and disease-state-vs-healthy plasma comparisons in autoimmune research.
Quick Summary
Serum from SLE donors, qualified under 21 CFR 1271 with the same 14-marker infectious disease screening (HIV-1/2, hepatitis B/C, HTLV-I/II, West Nile, Chagas plus CMV, EBV, alloantibodies) applied to all OrganaBio donors. Sourced from OrganaBio's recallable donor pool with NGS HLA typing across HLA-A, B, C, DR, DQ, DP. Best fit: SLE biomarker discovery, autoantibody panel development, and in vitro autoimmune research.
Quick Summary
PBMCs from systemic lupus erythematosus (SLE) donors, isolated from leukopak material under cGMP-aligned conditions. Sourced from OrganaBio's qualified, recallable donor pool with 14-marker infectious disease screening per 21 CFR 1271 and high-resolution NGS HLA typing. OrganaBio reports an average 99.1% PBMC viability across more than 2,500 clinical samples. Best fit: autoimmune drug screening, biomarker discovery, and disease-state immune dysregulation studies.
Quick Summary
B cells isolated from peripheral blood leukopaks via CD19+ immunomagnetic enrichment. Sourced from OrganaBio's over 50,000 donors; eligible donors can be scheduled for repeat collections with 14-marker infectious disease screening and NGS HLA typing across HLA-A, B, C, DR, DQ, DP. Available as RUO and cGMP from the same donor pool under one quality system. Best fit: B-cell biology research, antibody-mediated cell therapy programs, and B-cell-targeted CGT preclinical work.
Quick Summary
Monocytes isolated from peripheral blood leukopaks via CD14+ enrichment. Common starting material for macrophage and dendritic cell differentiation studies. Sourced from OrganaBio's recallable donor pool with full 14-marker infectious disease screening and high-resolution NGS HLA typing. Available as RUO and cGMP from one quality system. Best fit: macrophage polarization studies, monocyte-derived dendritic cell programs, and innate immunity research.
Quick Summary
Mesenchymal stem cells from umbilical cord tissue, sourced through OrganaBio's GaiaGift perinatal subsidiary (wholly owned, FDA-registered). IRB-approved donor consent and 14-marker infectious disease screening per 21 CFR 1271. Available as RUO and cGMP from the same source pool. Best fit: regenerative medicine research, immunomodulation studies, and MSC-based cell therapy preclinical programs.
Quick Summary
Mesenchymal stem cells from placental tissue, collected through GaiaGift's perinatal collection network with IRB-approved consent and 14-marker infectious disease screening per 21 CFR 1271. Available as RUO and cGMP from one source pool under one quality system. Best fit: regenerative medicine research, immunology studies, and placental-MSC-specific preclinical work.
Quick Summary
T cells isolated from peripheral blood leukopaks via CD3+ enrichment. Sourced from OrganaBio's recallable donor pool with NGS HLA typing across six genes (HLA-A, B, C, DR, DQ, DP) and KIR genotyping where relevant. Available across RUO and cGMP grades from the same pool. Best fit: T-cell-based CGT programs, TCR engineering research, and immune cell therapy preclinical work.
Healthy-donor PBMCs
Cryopreserved peripheral blood mononuclear cells from healthy-donor peripheral-blood leukopaks, listed in the current catalog in 10M, 25M, 50M, and 100M cell formats.
Requests can be scoped to the program and available donor criteria from OrganaBio's independent, recallable leukapheresis donor pool of over 50,000 donors. Confirm product-specific availability, grade, and characteristics with the scientific team.
Quick Summary
NK cells isolated from peripheral blood leukopaks via CD56+ enrichment. Sourced from OrganaBio's qualified donor pool with KIR genotyping, relevant for NK-cell-therapy programs and KIR/HLA mismatching. 14-marker infectious disease screening and NGS HLA typing per donor. Best fit: NK-cell-based CGT programs, KIR-mismatch research, and innate-cell-therapy preclinical work.
Quick Summary
Cryopreserved leukopaks from healthy donors, 10 billion or more cells per single-donor unit. Sourced from OrganaBio's over 50,000 donors; eligible donors can be scheduled for repeat collections via HemaCenter (wholly owned, FDA-registered apheresis subsidiary). 14-marker infectious disease screening, NGS HLA typing across HLA-A, B, C, DR, DQ, DP, and KIR genotyping. Available as RUO and cGMP from the same pool. Best fit: downstream immune cell isolation, CGT starting material, and research programs needing predictable per-experiment cell counts.
Quick Summary
Fresh, non-mobilized leukopaks from healthy donors, delivered for same-day or next-day downstream isolation. 10 billion or more cells per single-donor unit. Sourced from OrganaBio's recallable donor pool via HemaCenter (wholly owned, FDA-registered). 14-marker infectious disease screening and NGS HLA typing on every donor. Best fit: programs requiring fresh starting material for immediate isolation rather than cryopreserved.
Quick Summary
T cells isolated from cord blood, collected via OrganaBio's GaiaGift perinatal subsidiary (wholly owned, FDA-registered) under IRB-approved consent and 14-marker infectious disease screening per 21 CFR 1271. Available as RUO and cGMP from the same source pool. Best fit: cord-blood T-cell biology, allogeneic CGT preclinical work, and research programs needing cord-blood-specific T cell phenotypes.
Quick Summary
NK cells from cord blood, sourced through GaiaGift with IRB-approved donor consent and 14-marker infectious disease screening. Cord blood NK cells offer different biological profiles than peripheral blood NK cells, including more naive phenotypes useful for certain CGT programs. KIR genotyping available. Best fit: cord-blood NK CGT programs, NK biology research, and allogeneic NK cell therapy preclinical work.
Quick Summary
CD34+ hematopoietic stem cells from cord blood, with cGMP manufacturing service launched in 2024 under OrganaBio's quality system. Sourced via GaiaGift (wholly owned, FDA-registered) under IRB-approved consent and 14-marker infectious disease screening per 21 CFR 1271. NGS HLA typing across HLA-A, B, C, DR, DQ, DP supports allogeneic donor matching. Best fit: HSCT research, gene therapy programs, and allogeneic CGT starting material where lower GvHD risk and easier HLA matching matter.
Quick Summary
Fresh whole cord blood units from GaiaGift (wholly owned, FDA-registered), delivered for downstream isolation, cell expansion, or research applications. Each unit collected under IRB-approved consent with 14-marker infectious disease screening per 21 CFR 1271. Best fit: research programs requiring fresh cord blood as starting material for in-house isolation rather than pre-isolated cells.
What Are PBMCs? Composition, Isolation, and Why Source Quality Matters
SA
Sarah Alter, PhD Lab Director · OrganaBio · June 2026
⏱ 8 min read
85%
isolation yield
5 types
PBMC subsets
What PBMCs are and what they contain
Peripheral blood mononuclear cells (PBMCs) are the fraction of blood cells characterized by a single, round nucleus. The term refers to a collection of different cell types isolated together, not a single cell type. When someone says “we ordered PBMCs,” they mean a mixed population of immune cells separated from red blood cells, platelets, and granulocytes.
The major cell types in a PBMC preparation from a healthy donor:
These ranges are approximate. Actual frequencies vary substantially by donor — which is why immunophenotype data matters when selecting donors for specific applications.
How PBMCs are isolated
The standard isolation method is density gradient centrifugation, most commonly using Ficoll or equivalent density media. The principle: blood components separate by density when centrifuged. PBMCs settle at the interface between the density medium and the plasma layer; red blood cells and granulocytes pellet to the bottom.
The key process variables that affect PBMC quality:
Time from collection to processing: Longer hold times degrade viability and subset ratios. OrganaBio processes leukopaks inside the same operation that collected them, so the material is not in transit before the first processing step. Processing delays of more than 8 hours can meaningfully affect monocyte and NK cell function.
Temperature during transport: PBMCs should be transported at room temperature (18–25°C). Cold temperatures can cause monocyte aggregation; elevated temperatures accelerate cell death.
Centrifugation parameters: Speed, acceleration, and deceleration settings affect the cleanness of the interface and granulocyte contamination in the final prep. Granulocyte contamination greater than 5% reduces PBMC preparation quality for most functional assays.
PBMC yield from a leukopak
A standard full leukopak contains 10 billion or more total white blood cells. PBMC recovery from a leukopak using optimized density gradient separation is typically 70–85% or higher — meaning 7–8.5 billion or more PBMCs from a single collection. OrganaBio does not publish a yield threshold for this step; co-located collection and processing is what keeps the interval before first spin short.
For comparison, a single unit of whole blood yields approximately 100–300 million PBMCs — roughly 30–100x fewer cells than a leukopak from the same donor.
Scale consideration: A CAR-T or CAR-NK process development run typically requires 50–500 million T or NK cells as starting material. A single leukopak provides enough cells for multiple process runs, donor characterization, and cryopreservation banking — without requiring multiple donor collections.
Both formats have appropriate use cases. The choice depends on your assay requirements and workflow logistics, not on one format being universally better.
Consideration
Fresh PBMCs
Cryopreserved PBMCs
Cell viability on receipt
Typically >95%
>90% post-thaw (optimized cryo)
Functional status
Fully active
Some activation upon thaw; rest period recommended
The value of PBMC characterization data depends on your application. Here is what matters at different levels:
Minimum for most research applications:
Donor age, sex, race/ethnicity
CMV serostatus (CMV+ and CMV- donors have measurably different NK and T cell repertoires)
Basic infectious disease screen (HBV, HCV, HIV, syphilis at minimum)
Cell count and viability at release
For cell therapy and immunotherapy applications:
HLA typing — 6-gene NGS HLA (HLA-A, B, C, DR, DQ, DP) for allogeneic program donor selection
Immunophenotype panel — T/B/NK/monocyte subset frequencies and activation markers
Donor health history and medication history
Option to recall the same donor for subsequent collections
PBMCs as starting material for cell therapies
For autologous T cell therapies (patient-derived CAR-T), the starting material is the patient’s own apheresis product. For allogeneic programs using healthy donor cells — allogeneic CAR-T, CAR-NK, and TCR-T programs — PBMCs from a characterized, recallable donor pool are the standard starting material.
The practical criteria for allogeneic starting material:
Consistent T or NK cell frequency to ensure predictable cell dose
HLA typing for donor selection and product matching
Absence of immune activation markers that could reduce T cell expansion potential
The ability to reorder from the same donor for longitudinal process runs
OrganaBio’s leukopak-derived PBMCs include HLA typing, immunophenotype characterization, and donor recallability as standard features for cell therapy research applications.
Quality signals that indicate a reliable PBMC supplier
Published or available processing time from collection to first spin (shorter is better)
Granulocyte contamination rate specified on CoA (well-characterized preps target <5%)
Immunophenotype data with your order, not just cell count and viability
Donor recallability for longitudinal work
Clear RUO designation with a documented GMP path if your program will advance
Chain-of-custody documentation from donor apheresis to final product
What are PBMCs?
PBMCs (peripheral blood mononuclear cells) are the fraction of blood cells with a round nucleus — primarily T cells, B cells, NK cells, and monocytes. They are isolated from whole blood or leukopaks by density gradient centrifugation, which separates them from red blood cells and granulocytes. PBMCs are widely used in immunology research, cell therapy process development, and drug screening.
What percentage of PBMCs are T cells?
In healthy donors, T cells typically represent 65-85% of PBMCs, with CD4+ helper T cells making up roughly 40-60% and CD8+ cytotoxic T cells making up 20-35%. The exact proportions vary by donor and are influenced by age, health status, CMV serostatus, and other factors — which is why immunophenotype data from the supplier matters.
What is a typical PBMC yield from a leukopak?
A standard full leukopak yields 10 billion or more total white blood cells, with PBMC recovery typically at 70% or greater after density gradient isolation. OrganaBio publishes no recovery threshold for leukopak-derived PBMCs, because a single figure across a heterogeneous starting material would not carry weight. Actual yield depends on donor, collection method, and processing time.
Fresh vs. cryopreserved PBMCs: which should I use?
Fresh PBMCs are optimal for functional assays that require activated or metabolically active cells — proliferation assays, cytokine secretion, NK cell killing. Cryopreserved PBMCs are better for batched studies, longitudinal experiments using the same donor, and any workflow requiring scheduled assay timing. Post-thaw viability of greater than 90% is achievable with optimized cryopreservation protocols.
What donor data should come with PBMCs?
Minimum useful donor data for research applications: age, sex, race/ethnicity, CMV serostatus, and basic health screen. For cell therapy applications: 6-gene NGS HLA typing (HLA-A, B, C, DR, DQ, DP), immunophenotype panel (T/B/NK/monocyte frequencies), and infectious disease panel results. The more detailed the donor characterization, the more efficiently you can select donors for specific applications.
PBMCs (peripheral blood mononuclear cells) are the fraction of blood cells with a round nucleus — primarily T cells, B cells, NK cells, and monocytes. They are isolated from whole blood or leukopaks by density gradient centrifugation, which separates them from red blood cells and granulocytes. PBMCs are widely used in immunology research, cell therapy process development, and drug screening.
What percentage of PBMCs are T cells?
In healthy donors, T cells typically represent 65-85% of PBMCs, with CD4+ helper T cells making up roughly 40-60% and CD8+ cytotoxic T cells making up 20-35%. The exact proportions vary by donor and are influenced by age, health status, CMV serostatus, and other factors — which is why immunophenotype data from the supplier matters.
What is a typical PBMC yield from a leukopak?
A standard full leukopak yields 10 billion or more total white blood cells, with PBMC recovery typically at 70% or greater after density gradient isolation. OrganaBio publishes no recovery threshold for leukopak-derived PBMCs, because a single figure across a heterogeneous starting material would not carry weight. Actual yield depends on donor, collection method, and processing time.
Fresh vs. cryopreserved PBMCs: which should I use?
Fresh PBMCs are optimal for functional assays that require activated or metabolically active cells — proliferation assays, cytokine secretion, NK cell killing. Cryopreserved PBMCs are better for batched studies, longitudinal experiments using the same donor, and any workflow requiring scheduled assay timing. Post-thaw viability of greater than 90% is achievable with optimized cryopreservation protocols.
What donor data should come with PBMCs?
Minimum useful donor data for research applications: age, sex, race/ethnicity, CMV serostatus, and basic health screen. For cell therapy applications: 6-gene NGS HLA typing (HLA-A, B, C, DR, DQ, DP), immunophenotype panel (T/B/NK/monocyte frequencies), and infectious disease panel results. The more detailed the donor characterization, the more efficiently you can select donors for specific applications.
PBMCs (peripheral blood mononuclear cells) are the fraction of blood cells with a round nucleus — primarily T cells, B cells, NK cells, and monocytes. They are isolated from whole blood or leukopaks by density gradient centrifugation, which separates them from red blood cells and granulocytes. PBMCs are widely used in immunology research, cell therapy process development, and drug screening.
What percentage of PBMCs are T cells?
In healthy donors, T cells typically represent 65-85% of PBMCs, with CD4+ helper T cells making up roughly 40-60% and CD8+ cytotoxic T cells making up 20-35%. The exact proportions vary by donor and are influenced by age, health status, CMV serostatus, and other factors — which is why immunophenotype data from the supplier matters.
What is a typical PBMC yield from a leukopak?
A standard full leukopak yields 10 billion or more total white blood cells, with PBMC recovery typically at 70% or greater after density gradient isolation. OrganaBio publishes no recovery threshold for leukopak-derived PBMCs, because a single figure across a heterogeneous starting material would not carry weight. Actual yield depends on donor, collection method, and processing time.
Fresh vs. cryopreserved PBMCs: which should I use?
Fresh PBMCs are optimal for functional assays that require activated or metabolically active cells — proliferation assays, cytokine secretion, NK cell killing. Cryopreserved PBMCs are better for batched studies, longitudinal experiments using the same donor, and any workflow requiring scheduled assay timing. Post-thaw viability of greater than 90% is achievable with optimized cryopreservation protocols.
What donor data should come with PBMCs?
Minimum useful donor data for research applications: age, sex, race/ethnicity, CMV serostatus, and basic health screen. For cell therapy applications: 6-gene NGS HLA typing (HLA-A, B, C, DR, DQ, DP), immunophenotype panel (T/B/NK/monocyte frequencies), and infectious disease panel results. The more detailed the donor characterization, the more efficiently you can select donors for specific applications.
For Research Use Only. All OrganaBio primary human cell products are intended for research use only. They are not validated for, nor intended for use in, diagnostic or therapeutic procedures, clinical manufacturing without a quality agreement, or administration to humans outside of an approved investigational protocol.
PBMCs arrive in more than one form and the differences are not cosmetic. What suits a phenotyping panel is frequently wrong for a monocyte-dependent workflow, and the decision is easier made before purchase than explained afterwards.
Format
Best for
Watch for
Cryopreserved isolated PBMCs
Most phenotyping and functional work, multi-site and repeat-measure designs
Monocyte recovery is lower than input frequency; rest after thaw
Three numbers appear on almost every specification and they measure different things. Viability records the proportion alive at a stated timepoint, and pre-freeze and post-thaw are not interchangeable. Recovery records how many cells came back relative to input and is the one that determines whether you have enough material. Purity records the proportion belonging to the target population and is only interpretable alongside the marker and gating strategy.
They also trade against each other, so a specification with all three high is less common than a specification that has been optimised for whichever one mattered. This is covered in viability, recovery and purity, and how to read the rest of the document is in reading a certificate of analysis.
A blank line is not a guarantee. Where a specification field is empty, it means no threshold is published rather than that quality is assured. Some formats genuinely cannot carry a single meaningful figure, and a supplier who publishes a number for everything is telling you something about how they treat specifications generally.
Donor characterisation, and why it predicts your results
Two PBMC lots with identical cell counts are not equivalent products if one arrives with a characterised donor and the other arrives with a lot number. Several donor attributes move functional results more than most variables under active study.
HLA type determines which peptides a donor can present, making it a hard constraint on any T cell assay. KIR genotype, read against target HLA class I, shapes NK behaviour in ways no NK frequency predicts. Prior cytomegalovirus exposure substantially reshapes the memory compartment. Age and sex both influence immune composition independently.
OrganaBio documents a 14-marker infectious disease screening panel, high-resolution NGS HLA genotyping across HLA-A, HLA-B, HLA-C, HLA-DR, HLA-DQ and HLA-DP, and KIR genotyping as part of the donor programme rather than per order. That is what allows donor selection by genotype, subject to availability, rather than explanation after the fact. The reasoning sits in KIR genotyping and the HLA typing guide.
Where to get them
OrganaBio supplies PBMCs and the material they are isolated from through one donor programme, with collection through its own apheresis subsidiary and processing within the same operation across Miami, Irvine, Hayward and San Diego.
Isolated monocytes, where fresh material is often preferable
Disease-state PBMCs are documented separately across 24 autoimmune indications for research use, with a viability specification of greater than 80% post-thaw that is deliberately distinct from healthy-donor figures.
Questions worth asking before you buy
Does the supplier collect the material themselves, or resell it. Is donor characterisation applied at programme level or generated on the lot you bought. Can the same donor be collected from again in eighteen months. How long elapses between collection and first processing. And does clinical-grade material come from the same donor pool under the same quality system as the research grade.
Those five discriminate between suppliers far better than any specification sheet, and the reasoning behind each is set out in how to evaluate a PBMC supplier.
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.
Sarah Alter, Ph.D.
Lab Director
Sarah Alter, Ph.D., is Laboratory Director at OrganaBio, LLC, where she provides technical leadership across laboratory operations, process development, product manufacturing, and clinical sample processing services supporting cell and gene therapy developers worldwide. She brings more than 20 years of immunology and translational research experience spanning autoimmunity, oncology, and infectious disease.
Since joining OrganaBio in 2018, Dr. Alter has progressed through roles of increasing responsibility, first as Director of Immunology, leading development and manufacturing of human-derived immune cell products for immuno-oncology partners and clients; then as Senior Director of Scientific Affairs, where she served as immunology subject matter expert and shaped scientific strategy across new product launches, market analyses, and client engagements. She also served as founding Managing Director of HemaCenter, LLC, OrganaBio’s FDA-registered leukapheresis collection subsidiary, where she stood up operations, recruited the medical team, and authored governing protocols and SOPs.
Earlier in her career, Dr. Alter led preclinical R&D for IL-15–based immunotherapies at Altor BioScience (now ImmunityBio), contributing to programs that advanced into the clinic and co-authoring numerous peer-reviewed publications. She holds a Ph.D. in Immunology from the University of Miami Miller School of Medicine and an M.Sc. in Microbiology from Florida Atlantic University, and is a registered Patent Agent licensed to practice before the U.S. Patent and Trademark Office.
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.
