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 1,000+ qualified, recallable donor pool 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.
Quick Summary
PBMCs isolated from healthy-donor peripheral blood leukopaks. OrganaBio reports an average 99.1% post-thaw viability, PBMC recovery of 70% or more, and average composition of 60% T cells and 18% NK cells. 14-marker infectious disease screening per 21 CFR 1271 and NGS HLA typing on every donor. Available as RUO and cGMP from the same 1,000+ donor pool. Best fit: immunology research, drug screening, and CGT starting material across preclinical to clinical use.
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 1,000+ qualified, recallable donor pool 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.
20 Questions to Ask Before Choosing a Primary Cell Supplier
SA
Sarah Alter, PhD Lab Director · OrganaBio · June 2026
⏱ 7 min read
20
vetting questions
Free
sourcing checklist
Category 1: Cell Quality and Specifications
1. What is the minimum total nucleated cell (TNC) count per leukopak? This is the most basic yield spec. A supplier that cannot commit to a TNC minimum is not operating to a standard — they’re shipping what they collect. For most downstream isolation workflows, ≥10 billion TNC is the functional threshold.
2. What is the maximum granulocyte percentage in your leukopaks? Granulocytes contaminate PBMC fractions, reduce viability post-isolation, and degrade product quality on shipment. The acceptable ceiling for research-grade leukopaks is <3% granulocytes. Ask for historical batch data, not just a spec sheet claim.
3. What viability do you guarantee at release, and what post-thaw viability should I expect for cryopreserved products? Release viability and post-thaw viability are different numbers. Both should be specified. A supplier that only provides release viability on a cryo product is leaving you to discover the post-thaw number in your own lab.
4. What is your isolation method for purified cell populations (T cells, NK cells, B cells)? Negative selection preserves native receptor expression on the target cell population. Positive selection can activate cells during isolation. The method affects downstream assay interpretation, especially for functional studies and CAR manufacturing.
5. How do you demonstrate batch-to-batch consistency? Ask for CoAs across 5–10 consecutive batches of a specific product. Look for variance in TNC, granulocyte %, viability, and cell subset frequencies. High variance across batches means your assay results are confounded by material variability.
Category 2: Donor Data and Characterization
6. What HLA typing do you provide, and at what resolution? For cell therapy research, allele-level NGS typing (G-code format) across HLA-A, B, C, DRB1, DQB1, and DPB1 is the standard. Serologic or low-resolution typing is insufficient for programs requiring donor matching or KIR-ligand mismatch analysis. See HLA-typed PBMCs for cell therapy research for full context on why resolution matters.
7. Do you provide CMV serostatus for all donors? CMV status reshapes the NK and T cell compartments. Without CMV data, you cannot control for adaptive NK cell populations or heavily differentiated CD8+ T cell subsets that dominate in CMV+ donors. CMV status should be available on every donor, not just on request.
8. What immunophenotype data is included with each lot? A useful immunophenotype panel covers CD3/CD4/CD8 T cells, CD19 B cells, CD14 monocytes, CD56/CD16 NK cells, and ideally Treg percentage. Pre-collection phenotype data is more useful than day-of CoA data alone — it lets you select donors by baseline immune composition before ordering.
9. Can you provide longitudinal data from repeat donors? For programs studying immune function over time or requiring matched timepoints, the ability to pull data from the same donor across multiple collections is a hard requirement. Ask whether the supplier tracks longitudinal phenotype data and whether it is available to clients.
Category 3: Quality Documentation
10. What does your Certificate of Analysis include? A complete CoA for primary human cells should include: TNC or cell count, viability, subset purity (if applicable), donor demographics, CMV status, HLA type, release testing results, and lot number traceability. Review a sample CoA before ordering, not after.
11. Are you 21 CFR Part 1271 compliant for human cellular and tissue-based products (HCT/P)? This is the FDA regulatory framework covering donor eligibility determination, screening, and testing for HCT/Ps. Compliance indicates the supplier operates under federal donor safety standards, which also provides a baseline for their process and documentation rigor.
12. What infectious disease testing panel do you run on donors? At minimum, the standard panel includes HIV-1/2, HBV, HCV, HTLV-I/II, syphilis, and CMV. Ask whether the supplier treats the ID panel as a minimum or as part of a more comprehensive screening protocol, and verify that results are reported on the CoA.
13. What is your chain of custody documentation from collection to shipment? For programs that will eventually transition to cGMP, chain of custody documentation from the apheresis collection to final product release should be available. Gaps in documentation at the RUO stage become audit findings at the cGMP stage.
14. Do you offer cGMP-grade material, and from the same donor pool as RUO? If your program will eventually require cGMP-grade starting material, a supplier that draws from a separate cGMP donor pool forces you to re-qualify material and potentially rerun development work. The same characterized donor pool serving both RUO and cGMP is a structural advantage. See RUO vs. cGMP starting material for the transition framework.
15. What changes when you move from RUO to cGMP grade? Ask the supplier to describe the specific process, documentation, and testing differences between their RUO and cGMP products. If they cannot articulate those differences clearly, their cGMP offering may not be meaningfully different from their RUO products in practice.
16. What quality management infrastructure supports cGMP manufacturing? The minimum credible answer includes ISO-7 cleanroom, process and cleaning validation, batch record system with lot traceability, CAPA process, and QA-released product. Verbal claims are not sufficient — ask to see the quality manual or a sample batch record.
Category 5: Recallability and Longitudinal Programs
17. How large is your actively recallable donor pool, and how do you define “active”? Total registered donors is not the same as actively recallable donors. An actively recallable donor is one who has been contacted recently, confirmed their availability, and can be scheduled within a reasonable window. For programs requiring matched donor material across years, a pool of 500+ actively recallable donors is a practical floor.
18. Can you pre-screen your pool for specific phenotypes before a collection? For rare phenotype requirements (CMV-negative, specific HLA type, high NK frequency, particular KIR genotype), a supplier with a characterized donor pool can screen before scheduling — rather than you discovering a mismatch after collection. Ask whether pre-screening is a standard service or a custom arrangement.
Category 6: Logistics and Turnaround
19. What is the lead time for fresh leukopaks, and what are the processing-to-shipment and delivery windows? Fresh leukopaks are time-sensitive. You need to know the typical window from collection to your lab, and whether the supplier can meet same-week or next-day scheduling for urgent requests. Shipping logistics and geographic coverage matter as much as collection capability.
20. What handling instructions accompany cryopreserved shipments, and what is your packaging validation? Improper shipping temperature during transport is the most common cause of poor post-thaw viability in cryopreserved cells. Ask for packaging validation data demonstrating temperature maintenance during representative shipping scenarios.
The fastest way to evaluate a supplier: request a sample data package — a CoA, a sample batch record summary, and donor characterization data for one lot. How long it takes them to provide it, and how complete it is, tells you more than their catalog description.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
What TNC yield should I require from a leukopak supplier?
A standard leukopak should provide ≥10 billion total nucleated cells (TNC). This is the baseline threshold for downstream isolation workflows. Suppliers that cannot provide a minimum TNC specification on their CoA are not producing to a controlled standard.
Should a primary cell supplier offer both RUO and cGMP products?
Yes, and more importantly, they should supply both from the same characterized donor pool. Switching suppliers when you transition from RUO to cGMP manufacturing means qualifying new donors, validating new material, and potentially losing reproducibility across your development timeline.
What HLA typing depth is sufficient for cell therapy research donors?
Allele-level NGS typing across at least 6 genes (HLA-A, B, C, DRB1, DQB1, DPB1) in G-code format is the current standard for cell therapy donor characterization. Serotyping or low-resolution typing is insufficient for programs that require donor-recipient matching or KIR-ligand mismatch analysis.
How large does a supplier’s donor pool need to be for a longitudinal study?
For longitudinal studies requiring the same donor across multiple timepoints, you need a supplier with a large actively recallable pool — not just a total donor count. A pool of 500+ actively recallable donors provides enough breadth to find specific phenotypes while ensuring supply continuity for multi-year programs.
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.
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.
