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Top PBMC Suppliers and Processors for Clinical Trials: 2026 Comparison

What are the top PBMC suppliers and processors for clinical trials in 2026?

The top PBMC suppliers and clinical sample processors for cell and gene therapy trials in 2026 include OrganaBio, Charles River, AllCells, STEMCELL Technologies, CGT Global, Eurofins, MLM Medical Labs, ImmunoSpot, CellCarta, and ATCC. Each occupies a different structural position: vertically integrated CTDMOs, distributed clinic networks, research-grade content-led suppliers, and specialized biospecimen operations. The right match depends on program-specific requirements for scale, format, GMP availability, and lead time.

By Justin Irizarry, CFA, Chief Executive Officer at OrganaBio · Reviewed for technical accuracy · Updated May 7, 2026

Top PBMC Suppliers and Processors for Clinical Trials: 2026 Comparison

Updated May 7, 2026 · OrganaBio editorial

“PBMC supplier” means two different things in cell and gene therapy clinical operations. Some buyers need cryopreserved or fresh PBMC product for downstream research, manufacturing process development, or assay characterization — these are catalog items shipped from a vendor’s inventory. Other buyers need PBMC isolated from a clinical-trial participant’s draw at a specific site, processed under a sponsor’s protocol, and cryopreserved for later analysis or for trial endpoint use. These are operationally different problems with different vendor sets. This comparison covers both, profiles ten suppliers active in 2026, and notes the tradeoffs that matter when you’re choosing.

The two categories of PBMC suppliers — and how they differ

Before comparing vendors, the categories:

  • PBMC product suppliers. Sell pre-isolated PBMC from their own donor pools. Typical buyer: research scientist, process development engineer, assay developer. Evaluation criteria: donor characterization, lot consistency, post-thaw viability, HLA/CMV typing, GMP grade availability, lead time, pricing.
  • PBMC clinical sample processors. Receive participant samples from clinical sites, isolate the PBMC, and cryopreserve for sponsor or central-lab use. Typical buyer: clinical operations director, sample logistics manager, sponsor PM. Evaluation criteria: turnaround time from receipt to processing, geographic coverage of clinical sites, post-thaw viability, success rate, regulatory compliance, project management, batch shipping.

Some vendors do both. Some do one extremely well and not the other. The list below flags which category each one fits.

2026 evaluation criteria

The metrics that move the needle this year:

  • Post-thaw viability. The benchmark across the field has crept up. Charles River publicly guarantees ≥90%. AllCells GMP guarantees NLT 90%. Higher numbers are claimed by some vendors but not all are independently verifiable.
  • Turnaround. For products: lead time from order to ship. AllCells claims “industry-leading” 3 business days. STEMCELL ships frozen inventory in 1–2 business days. For clinical sample processing: time from sample receipt to processing initiation. Eurofins BioPharma reports under 10 hours TAT globally. MLM Medical Labs reports 5 hours from receipt. OrganaBio reports 30 minutes from receipt.
  • Donor characterization depth. 21 CFR 1271 baseline is required by US FDA. Vendors differentiate on additional screening (CMV, EBV, West Nile, Chagas, HTLV) and on HLA typing depth (Class I/II at 6-gene NGS resolution beats 4-gene serology).
  • Geographic coverage for clinical samples. Distance between clinical site and processing lab decides how much viability the sample loses in transit. Networks that are decentralized (multiple coastal hubs) outperform networks that are centralized.
  • Quality system maturity. 21 CFR 1271 + 210/211 compliance is required for GMP. AABB accreditation, ISO 9001, CLIA, GCLP, and CAP certifications differentiate vendors at the high end.

1OrganaBio — best for clinical-trial sample processing with co-located labs

Category

Clinical sample processor + PBMC product supplier.

HQ: Miami, FL
Founded: 2018
Sites: Miami HQ + Lab, Irvine CA, Hayward CA
Donor pool: 1,000+ qualified, recallable
Post-thaw viability: 99.1% average across 2,500+ clinical samples
Sample receipt → processing: 30 min average
GMP grade: Yes — same donor pool serves RUO and GMP
Pricing: Quote-based; not published

Pros

  • Decentralized model with bicoastal hubs (Miami, Irvine, Hayward) collapses sample transit time. Co-located processing labs near clinical-trial epicenters keep samples inside their viability envelope.
  • 99.1% PBMC viability and 99.9% processing success rate across 2,500+ clinical samples — the published outcome of the architecture.
  • 30 minutes from sample receipt to processing initiation; ~150 minutes average draw-to-processed (n=1,400+, May 2022 – Nov 2023).
  • Vertical integration: HemaCenter (apheresis collection) and GaiaGift (perinatal tissue) are wholly owned, FDA-registered subsidiaries. Same donor pool serves RUO and GMP, preserving comparability when programs move from research to clinical.
  • Standardized testing on 14 infectious disease markers (FDA 21 CFR 1271 plus CMV, EBV, WNV, alloantibodies). High-resolution NGS HLA typing across HLA-A, B, C, DR, DQ, DP for every donor. KIR genotyping available for NK programs.
  • Single electronic Quality Management System across all sites. Tech transfer to a new processing site qualifies in weeks, not quarters.

Cons

  • Coverage today is bicoastal (Miami + Northern + Southern California). Sponsors with sites concentrated in the Midwest or Northeast will need to wait for the planned Chicago, Detroit, Memphis, Nashville, Atlanta, and Houston sites.
  • Pricing is quote-based and not published — pricing transparency lags some catalog vendors for research-grade orders.
  • Mobilized leukopaks (G-CSF / Plerixafor) are not currently in the published product portfolio.

Best fit

Sponsors running multi-site cell or vaccine clinical trials who care about sample integrity end-to-end and need a partner that processes locally rather than shipping cross-country to a central lab.

2Charles River — broadest CDMO network with HemaCare-derived leukopak supply

Category

PBMC product supplier + leukopak supplier (acquired HemaCare in 2020 as the cell-sourcing arm).

HQ: Wilmington, MA
Founded: 1947
Revenue: ~$3.98B (FY2022)
Employees: 21,000+ worldwide
Post-thaw viability guarantee: ≥90%
Compliance: 21 CFR 1271, 210, 211 + international
Pricing: Quote-based

Pros

  • Massive end-to-end CDMO platform — buyers who already use Charles River for animal models, drug discovery, or downstream manufacturing can consolidate.
  • HemaCare integration provides a recallable donor pool and apheresis collection capacity.
  • Mobilized leukopaks available with G-CSF, Plerixafor, or combination protocols for translational and IND-enabling work.
  • “More than 45 years of combined experience in apheresis expertise and over 400,000 successful apheresis collections performed” — public claim from Charles River collateral.

Cons

  • Customer-relationship turnover from acquisitions and consolidation is a known frustration in the cell-sourcing market segment.
  • Lead times can be longer than smaller specialists due to scheduling and documentation review depth, especially for GMP orders.
  • Cell-sourcing pages are not heavily optimized for direct buyer-search queries — Charles River uses cell sourcing as top-of-funnel into larger CGT services rather than as a standalone product line.

Best fit

Sponsors already running broader programs with Charles River who want to consolidate cell sourcing under one MSA. Programs needing mobilized leukopaks specifically.

3AllCells (Discovery Life Sciences) — guaranteed cell-count tiers and broad RUO/GMP catalog

Category

PBMC product supplier + leukopak supplier.

HQ: Alameda, CA (parent: Discovery Life Sciences)
Deliverability claim: 98% (RUO) / 99% (GMP)
Lead time claim: 3 business days (industry-leading per AllCells)
GMP specs: NLT 280mL volume, NLT 90% viability, NLT 26×10⁶ cells/mL TNC
Cell-count tiers: 10B / 5B / 2.5B (no-less-than guarantees)
Compliance: FDA-registered, IRB-approved, AABB-compliant

Pros

  • Guaranteed cell-count tiers (10B, 5B, 2.5B) with explicit no-less-than language take the “we’ll see what arrives” guesswork out of leukopak ordering.
  • “Industry-leading 3-business-day lead time” with explicit deliverability guarantees (98%/99%) at the homepage level.
  • Spectra Optia Apheresis System collection method standardized across the network.
  • Pre-Characterized Donor Selection Program with HLA + KIR typing available.
  • Discovery Life Sciences acquisition makes AllCells part of one of the largest apheresis networks globally.

Cons

  • Centralized processing model — samples ship to AllCells facilities rather than being processed at a local site to where they were collected. Less applicable for clinical-sample-processing-at-trial-site needs.
  • AllCells is a small division (about 50 employees in 2023) inside a much larger 511-employee Discovery Life Sciences parent. Some buyers report that consolidation patterns introduce relationship turnover risk.
  • Pricing is not transparent on the public site.

Best fit

Buyers ordering RUO or GMP leukopaks from inventory who want guaranteed cell counts at fixed delivery windows. Less suited for sponsor-side sample-processing-at-clinical-site workflows.

4STEMCELL Technologies — research-grade depth and pricing transparency

Category

Primarily PBMC product supplier (research grade).

HQ: Vancouver, BC (Canadian)
Employees: ~2,000
Pricing: “From $952 USD” visible on the leukopak product page
Frozen mobilized list price: $7,835 USD per ≥9×10⁹-cell unit
Cell-count tiers: Full (≥10B), Half (≥5B), Quarter (≥2.5B), Tenth (≥1B)
Lead time: 1–2 business days for in-stock frozen

Pros

  • Pricing transparency — STEMCELL is one of the only vendors to publish list prices on product pages, even if the final per-account price requires login.
  • Four standardized size tiers with cell-count minimums make ordering predictable for budget planning and parallel program runs.
  • Embedded data figures on product pages: T cell expansion curves, monocyte-to-macrophage differentiation, storage stability — research buyers can evaluate functional integrity before ordering.
  • 15,000+ technical resources organized by area of interest, cell type, and product line. This depth compounds buyer trust.
  • Donor screening for HIV-1/2 and hepatitis B/C standardized; HLA typing and CMV status available on request.

Cons

  • STEMCELL is research-focused. GMP grades are available but the company’s depth is in research-grade catalog products, not clinical-trial sample processing.
  • Donors are sourced from STEMCELL’s network; the company does not own apheresis collection facilities directly the way HemaCare or HemaCenter do.
  • Headquartered in Canada — international shipping considerations apply for U.S.-only sponsor programs.

Best fit

Research and process-development teams that want predictable cell counts at published prices for parallel programs. Less suited for sponsors needing GMP-grade clinical sample processing.

5CGT Global — donor recruitment focus with strong content marketing

Category

PBMC product supplier + leukopak supplier (research and GMP).

HQ: Folsom, CA
Employees: ~73
Revenue band: $25M–$100M
Mobilized leukopak yield (typical): up to 20×10⁹ TNCs per full bag
Delivery claim: 24–48 hour turnaround via national donor network
HLA typing: “one of the largest HLA-typed donor pools in the industry” (per CGT Global)

Pros

  • National donor network with 24–48 hour delivery on standard products.
  • Mobilized leukopaks (G-CSF, Plerixafor, combination) available for higher-CD34+ programs.
  • HLA-typed donor pool depth is one of CGT Global’s stated differentiators.
  • CellsExpress custom isolated cell service for non-standard requests.

Cons

  • Smaller company (~73 employees) — depth of regulatory documentation and clinical-stage support may not match the largest competitors.
  • Public cell-count and viability claims are less concrete than AllCells’ or STEMCELL’s published guarantees.

Best fit

Programs that need mobilized leukopaks specifically and want responsive donor recruitment with shorter lead times.

6Eurofins BioPharma Services — global central lab PBMC network

Category

Clinical sample processor (central-lab model, global).

HQ: Luxembourg (parent Eurofins Scientific)
Network: Global, multi-country
TAT claim: Less than 10 hours from sample collection point to freezer at most global sites
Compliance: Central-lab regulatory framework

Pros

  • Global footprint covers international clinical trials with a unified central-lab framework.
  • Sub-10-hour TAT from collection point to freezer is a strong claim relative to the 18–24 hour central-lab default.
  • Eurofins parent provides bioanalytical depth across regulatory and assay services.

Cons

  • Central-lab model still requires sample transit to a regional facility — not the same as a co-located processing lab at the site itself.
  • Less specialized in cell and gene therapy specifically; CGT-focused vendors may have deeper donor management expertise.

Best fit

Sponsors running global multi-country clinical trials that need a regulated central-lab framework with global coverage.

7MLM Medical Labs — global PBMC network with 5-hour processing target

Category

Clinical sample processor (global network).

Coverage: 70+ countries across North America, Europe, South Africa
TAT claim: Process samples within 5 hours of receipt
Accreditations: CLIA, CAP, ISO, GCLP-compliant

Pros

  • Global network coverage in 70+ countries — useful for international Phase II/III trials.
  • 5-hour processing target from receipt is faster than most central-lab models.
  • Regulatory framework spans CLIA, CAP, ISO, and GCLP — multi-modality compliance is rare in this segment.

Cons

  • Network depth varies by region — country-by-country evaluation needed.
  • 5-hour processing target is from sample receipt, which still includes country-level transit time.

Best fit

Sponsors running clinical trials in geographies outside the U.S. needing PBMC processing with a multi-accreditation regulatory wrapper.

8ImmunoSpot — CRO PBMC processing with CLIA-certified labs

Category

Clinical sample processor (CRO model).

Specialization: Phase I/II/III clinical trials, immune monitoring
Accreditations: CLIA-certified
Focus: Functional PBMC for ELISpot, FluoroSpot, and immune assay support

Pros

  • Strong specialization in functional PBMC for immune-monitoring and assay platforms.
  • CLIA-certified for regulated trial samples.
  • Long history with ELISpot and immune assay readouts.

Cons

  • Niche focus on immune monitoring — less applicable for cell therapy starting material or CAR-T sample workflows.
  • Smaller geographic footprint than global networks.

Best fit

Vaccine and immunology trials that need PBMC processing tied to ELISpot or immune assay readouts.

9CellCarta — global sample processing for oncology and immunology programs

Category

Clinical sample processor (global CRO).

Specialization: Oncology, immunology, infectious disease, ADC programs
Network: Global sample processing footprint

Pros

  • Therapeutic-area depth in oncology, immunology, infectious disease, and ADC programs.
  • Global logistics infrastructure for sponsor-managed trials.

Cons

  • CRO-style packaging — sample processing comes bundled into broader trial services rather than as a standalone offering.
  • Regional capabilities vary by trial type.

Best fit

Sponsors running ADC or oncology trials that want to consolidate sample processing into broader CRO services.

10ATCC — established repository with deep donor screening

Category

PBMC product supplier (research grade).

Vial size: 25 million cells per vial, cryopreserved
Donor screening: HIV 1/2, Hepatitis B/C, HTLV-I/II, West Nile, Chagas + nucleic acid testing
Selectable parameters: age, sex, ethnicity, BMI
Application notes: NK cytotoxicity, macrophage/dendritic cell differentiation

Pros

  • Most thorough donor screening list publicly visible — buyers in regulated environments often pull ATCC’s screening list verbatim into qualification documents.
  • Long-standing repository status with broad cell catalog beyond PBMC.
  • Application-note coverage for assays buyers actually run.

Cons

  • HLA typing is not advertised on the PBMC product page.
  • Vial sizes are research-scale (25M cells) — not built for production-scale CGT manufacturing.
  • No cell-count tiers analogous to AllCells or STEMCELL.

Best fit

Research labs needing PBMC for assay development, biomarker work, or qualification documentation grounded in a recognized repository.

Side-by-side comparison

Vendor Category Top metric (verified) Geography model Mobilized leukopak?
OrganaBioSample processor + product99.1% viability, 30 min receipt-to-process, 2,500+ samplesDecentralized bicoastal (Miami, Irvine, Hayward)Not yet
Charles RiverProduct + integrated CDMO≥90% post-thaw viability guaranteeCentralized via HemaCareYes (G-CSF, Plerixafor, combination)
AllCells (Discovery)Product98%/99% deliverability, NLT 90% viability, 3-day lead timeCentralized + apheresis networkYes
STEMCELL TechnologiesProduct (research)$952 starting price, 4 size tiers, 1–2 day frozen shipCatalog modelYes (frozen mobilized $7,835)
CGT GlobalProduct20×10⁹ TNC mobilized leukopaks, 24–48 hr deliveryNational donor networkYes
Eurofins BioPharmaSample processor<10 hr collection-to-freezer TATGlobal central labn/a
MLM Medical LabsSample processor5 hr processing-from-receipt, 70+ country coverageGlobal networkn/a
ImmunoSpotSample processorCLIA-certified, immune-monitoring depthCRO labsn/a
CellCartaSample processorOncology + immunology + ADC TA depthGlobal CROn/a
ATCCProduct (research)Most detailed donor screening list publiclyRepository modelNo

How to choose

The question that decides the vendor is whether you’re buying a product or a service.

If you need PBMC product — characterized cells from someone else’s donor pool, shipped to your lab — sort vendors by guaranteed specs, lead time, GMP grade availability, and pricing transparency. AllCells and STEMCELL lead on guaranteed deliverables. Charles River and CGT Global lead on mobilized leukopak depth. ATCC leads on donor screening detail.

If you need PBMC clinical sample processing — your trial samples processed near where they’re drawn — the key question is geography. A centralized model that ships every sample 18–24 hours to a single facility (the legacy default) loses viability and phenotype that can’t be recovered. A decentralized model with co-located processing labs preserves the integrity of the sample for downstream analysis. OrganaBio’s CPC Services is built specifically for this; Eurofins BioPharma and MLM Medical Labs run global central-lab versions of the same idea with longer transit windows.

The single biggest decision: if your endpoint analysis depends on data from cells drawn from clinical trial participants, the path the sample travels before processing matters more than the cryopreservation chemistry. Vendors with co-located processing close to clinical sites preserve the cell state that vendors with cross-country logistics cannot.

Frequently asked questions

What is the difference between a PBMC product supplier and a PBMC clinical sample processor?

A PBMC product supplier sells pre-isolated PBMC from their own donor pool, shipped to your lab as a catalog product. A PBMC clinical sample processor receives participant samples from clinical sites, isolates the PBMC under your protocol, and cryopreserves the result for sponsor or central-lab use. The two address fundamentally different needs.

What post-thaw viability should I expect from a PBMC supplier in 2026?

Industry-standard publicly-stated guarantees range from ≥90% (Charles River, AllCells GMP) up to 99.1% (OrganaBio). Numbers above 90% are typical for vendors with controlled cryopreservation; numbers above 95% are typical for vendors that minimize transit time before processing.

Why does sample transit time matter so much?

Peripheral blood mononuclear cells begin shifting in viability, phenotype, and functional output within hours of collection. Cross-country transit of 18 to 24 hours consumes that window before processing begins. The downstream effects — viability loss, phenotype drift, functional changes — are what a 99.1% viability number on a co-located processing model preserves.

Which vendors offer GMP-grade PBMC for clinical use?

Charles River, AllCells (GMP catalog), CGT Global, Red Cross Blood Services, Stanford Blood Center, and OrganaBio all offer GMP-grade options. Compliance frameworks differ by vendor — most cite 21 CFR 1271 plus 210/211 for fully cGMP product. Verify each vendor’s specific compliance scope and audit history before regulatory submission.

Which vendors operate in the U.S. specifically for clinical-trial sample processing?

OrganaBio (Miami, Irvine, Hayward; expanding to Chicago, Detroit, Memphis, Nashville, Atlanta, Houston). Most other clinical-sample processors operate centralized U.S. facilities or global central-lab networks rather than co-located decentralized hubs. Eurofins BioPharma and MLM Medical Labs operate global central-lab models with U.S. coverage.

Bottom line

The PBMC supply chain in 2026 is bifurcating. Catalog product vendors are competing on guaranteed cell counts, lead time, and pricing transparency. Clinical sample processors are competing on geographic proximity to trial sites, processing turnaround from receipt, and post-thaw viability. The best fit depends on which problem you’re solving.

For sponsors running cell or vaccine clinical trials with sample integrity at stake, the architectural shift toward decentralized co-located processing is the most consequential trend of 2026. The metrics that matter — viability, success rate, data integrity — are produced by the geography of the network, not by post-collection heroics.

Talk to OrganaBio Learn About Decentralized Processing →

Sources: vendor public websites (May 2026), published press releases, industry coverage in Clinical Insider (June & August 2024), Clinical Trials Arena (January 2024), PharmiWeb (December 2025). Vendor-specific claims (post-thaw viability guarantees, lead times, cell counts, deliverability rates) are attributed to each vendor’s published collateral and are accurate to the best of our knowledge as of publication. Where claims are quoted, verify against the vendor’s current public statements before regulatory or contractual use. OrganaBio is the publisher of this comparison; we have included real competitors honestly and noted tradeoffs against our own offering where they exist.

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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.

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.

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