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Cell & Gene Therapy Glossary

A comprehensive reference of terms used in cell therapy, gene therapy, and starting material procurement. This glossary covers key concepts relevant to researchers, clinical teams, and procurement professionals working with cell-based therapeutics.

Jump to:
A · B · C · D · E · F · G · H · I · K · L · M · N · P · R · S · T · U · V

A

Allogeneic
Derived from a donor who is genetically different from the recipient. Allogeneic cell therapies use cells from healthy donors rather than the patient, enabling off-the-shelf manufacturing. OrganaBio provides allogeneic starting materials including cord blood-derived NK cells and T cells.

Apheresis
A procedure that separates specific blood components (such as white blood cells) from a donor’s blood, returning the remaining components to the donor. Leukapheresis specifically collects leukocytes. OrganaBio’s subsidiary HemaCenter operates FDA-registered apheresis collection centers.

Autologous
Derived from the patient’s own cells. Autologous cell therapies require collecting cells from each individual patient, processing them, and returning them to the same patient. Fresh leukopaks are commonly used as starting material for autologous CAR-T manufacturing.

B

Biopreservation
The process of preserving biological materials for future use while maintaining cell viability and function. Includes cryopreservation (freezing) and hypothermic storage (cold but not frozen).

B Cells
A class of lymphocytes identified by expression of CD19 and CD20, responsible for humoral immunity through antibody production. Subsets include naïve, memory, plasmablast, and plasma cells. OrganaBio offers primary human B cells isolated from peripheral blood leukopaks.

Buffy Coat
The fraction of a centrifuged blood sample containing white blood cells and platelets, located between the plasma and red blood cell layers. A less concentrated alternative to a leukopak for PBMC isolation.

C

CAR-T (Chimeric Antigen Receptor T Cell)
A type of immunotherapy where a patient’s or donor’s T cells are genetically modified to express a chimeric antigen receptor that targets specific cancer cells. CAR-T manufacturing requires high-quality T cell starting materials, typically from leukopaks.

CAR-NK (Chimeric Antigen Receptor Natural Killer Cell)
Similar to CAR-T but using NK cells as the effector cell. Cord blood-derived NK cells are increasingly used for CAR-NK development because of their naive phenotype and amenability to genetic modification.

CD3+
A cell surface marker present on all T lymphocytes. CD3+ selection is used to isolate pan T cells from blood products. OrganaBio’s LeukoPAC-T and ImmunoPAC-T products provide CD3+ T cells.

CD34+
A cell surface marker for hematopoietic stem and progenitor cells. CD34+ cells are used in transplantation, gene therapy, and regenerative medicine research. OrganaBio’s HematoPAC-HSC provides CD34+ cells from cord blood.

CD56+
A cell surface marker for natural killer (NK) cells. CD56+ selection is used to isolate NK cell populations for immunotherapy research and CAR-NK development.

Cell Viability
The percentage of living cells in a sample. Higher viability indicates better quality starting material and improved downstream results. OrganaBio achieves 99.1% average cell viability through co-located collection and processing (under 30 minutes from draw to processing).

cGMP (Current Good Manufacturing Practice)
FDA-enforced regulations ensuring pharmaceutical and biologic products are consistently produced and controlled according to quality standards. OrganaBio operates cGMP manufacturing facilities with ISO 7 cleanrooms.

Chain of Custody
The documented, unbroken tracking of biological materials from collection through processing, storage, and delivery. Vertical integration allows OrganaBio to maintain chain of custody from donor consent through final product delivery.

Co-location
The practice of placing collection and processing facilities in close physical proximity to minimize transit time. OrganaBio’s collection centers and processing labs share a parking lot, enabling processing within 30 minutes of collection rather than the 18-36 hours typical of overnight shipping.

Cord Blood
Blood collected from the umbilical cord and placenta after birth. Cord blood contains hematopoietic stem cells, naive T cells, and NK cells with unique properties valuable for cell therapy. OrganaBio collects cord blood through its subsidiary GaiaGift.

Cryopreservation
The process of preserving cells by cooling them to very low temperatures (typically in liquid nitrogen at -196C). Validated cryopreservation protocols maintain cell viability and function for long-term storage.

CTDMO (Contract Technology Development and Manufacturing Organization)
An organization that provides both process development and manufacturing services for cell and gene therapy products. OrganaBio operates as a purpose-built CTDMO, distinguishing itself from general contract labs.

CAR-M
Chimeric antigen receptor macrophage therapy, an emerging modality in which macrophages are engineered to target solid tumors through phagocytosis and antigen presentation. OrganaBio supplies primary human macrophages used as starting material in CAR-M development.

Certificate of Analysis (CoA)
A quality document issued by a manufacturer that lists the test results for a specific lot of product against predefined acceptance criteria. Required for GMP starting materials and standard for OrganaBio products. OrganaBio CoAs include 8-color immunophenotyping, high-resolution HLA typing across six genes, and CBC data on the donor and final product.

Chain of Identity (CoI)
Documentation that links the identity of the donor, the starting material, and the final product across the entire manufacturing lifecycle. Required for autologous therapies and recommended for allogeneic products. Distinct from Chain of Custody, which tracks physical handling.

Cold Chain
The logistics system that maintains cells or biological products within a specified temperature range from collection through delivery. For fresh leukopaks, typically 2-8°C ambient-controlled shipping; for frozen products, vapor-phase liquid nitrogen dry shippers with continuous temperature monitoring.

Comparability Study
A formal study demonstrating that a change in manufacturing process, facility, or starting material does not adversely affect the quality, safety, or efficacy of a biological product. ICH Q5E provides the regulatory framework. OrganaBio supports comparability studies through donor-matched RUO and GMP material from the same recallable donor pool.

Controlled-Rate Freezing
A cryopreservation method in which the cooling rate is controlled to a defined profile, typically around 1°C per minute through the phase transition, to minimize ice-crystal damage and maximize post-thaw viability. Standard for GMP-grade cryopreserved cell products.

Critical Quality Attribute (CQA)
A physical, chemical, biological, or microbiological property that must be within an appropriate range to ensure product quality. Identified through quality by design (QbD) methodology and codified in ICH Q8.

Cross-Reactive Idiotype (CRM)
Context-dependent term in immunology referring to reactivity patterns that may confound donor matching in T cell therapy programs. Relevant where high-resolution HLA typing and TCR characterization are required.

D

Donor Recallability
The ability to recall the same qualified donor for repeat collections over time. Recallable donors ensure batch-to-batch consistency by providing the same biological starting material across R&D and clinical manufacturing. OrganaBio maintains 1,000+ recallable donors.

Dendritic Cells
Antigen-presenting cells of myeloid or lymphoid origin, critical for initiating adaptive immune responses. Subsets include conventional (cDC1, cDC2) and plasmacytoid (pDC) dendritic cells. Used in immunotherapy research and vaccine development.

Donor Eligibility Determination
A documented determination under 21 CFR 1271.50 that a donor has been screened and tested in accordance with applicable requirements and is eligible as a source of cells or tissues for use in humans. Required for all OrganaBio GMP-tier products.

E

Engraftment
The process by which transplanted cells establish themselves and begin functioning in the recipient’s body. Successful engraftment is a primary endpoint in stem cell transplantation.

F

Flow Cytometry
A laboratory technique that measures physical and chemical characteristics of cells as they flow through a laser. Used for immunophenotyping, cell counting, and quality control of cell therapy products. OrganaBio offers up to 25-color flow cytometry analysis.

FDA Regulation 21 CFR 1271
The US regulation governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). Covers donor eligibility, current good tissue practice (CGTP), establishment registration, and adverse-event reporting. OrganaBio’s quality system is built to 21 CFR 1271 across both RUO and GMP product tiers.

G

GMP-Grade
Materials manufactured under cGMP conditions suitable for use in clinical trials and commercial therapies. GMP-grade starting materials require documented processes, qualified facilities, and regulatory compliance.

H

HLA (Human Leukocyte Antigen)
Proteins on cell surfaces that play a critical role in immune recognition. HLA typing is essential for donor-recipient matching in transplantation and for selecting appropriate donors for allogeneic cell therapy. OrganaBio provides high-resolution HLA typing using next-generation sequencing at 6 loci (A, B, C, DR, DQ, DP).

I

Immunophenotyping
The characterization of cells using antibodies that recognize specific surface markers. Used to identify cell types, assess purity, and verify product quality in cell therapy manufacturing.

IRB (Institutional Review Board)
An ethics committee that reviews and approves research involving human subjects. All donor collections at OrganaBio are conducted under IRB-approved protocols with informed consent.

iPSC (Induced Pluripotent Stem Cell)
A pluripotent stem cell generated by reprogramming somatic cells through defined transcription factors (originally Oct4, Sox2, Klf4, c-Myc). Used as a scalable source for differentiated cell types in allogeneic cell therapy programs.

K

KIR (Killer-cell Immunoglobulin-like Receptor)
A family of receptors expressed on NK cells that regulate their activation through interaction with HLA class I ligands. KIR-ligand mismatching is relevant to allogeneic NK cell therapy and CAR-NK program design.

L

Leukopak
A concentrated collection of white blood cells obtained via leukapheresis. Leukopaks contain T cells, B cells, NK cells, and monocytes and serve as the primary starting material for many cell therapies. OrganaBio’s LeukoPAC products are available fresh or cryopreserved.

M

MSC (Mesenchymal Stem/Stromal Cell)
Multipotent cells that can differentiate into bone, cartilage, and fat cells. MSCs also secrete anti-inflammatory and immunomodulatory factors. OrganaBio’s MesenPAC products provide MSCs from umbilical cord tissue and placental tissue.

Macrophages
Tissue-resident or monocyte-derived phagocytic cells with roles in innate immunity, tissue remodeling, and immune regulation. In vitro, human macrophages are typically differentiated from monocytes using M-CSF or GM-CSF over 5-7 days. OrganaBio supplies primary human macrophages pre-differentiated to defined polarization states (M0, M1, M2).

Monocytes
Circulating myeloid cells identified by CD14 expression, subdivided into classical (CD14++CD16-), intermediate (CD14++CD16+), and non-classical (CD14+CD16++) populations. Precursors to tissue macrophages and dendritic cells. OrganaBio supplies CD14+ monocytes isolated from peripheral blood leukopaks.

N

NK Cell (Natural Killer Cell)
A type of lymphocyte that plays a role in innate immunity by killing virus-infected and cancerous cells. NK cells are increasingly used in cancer immunotherapy, particularly CAR-NK approaches. Cord blood NK cells have advantages including naive phenotype and amenability to genetic modification.

P

PBMC (Peripheral Blood Mononuclear Cell)
A collective term for blood cells with a round nucleus, including lymphocytes (T cells, B cells, NK cells) and monocytes. PBMCs are isolated from whole blood or leukopaks and used extensively in immunology research and clinical monitoring.

Process Development
The systematic optimization of manufacturing processes to achieve robustness, reproducibility, and scalability. OrganaBio offers process development services using equipment including CliniMACS Prodigy, AutoMACS, and Sepax systems.

Placental Tissue
Perinatal tissue obtained at full-term birth, used as a source of mesenchymal stromal cells and extracellular matrix products for research and clinical applications. OrganaBio’s MesenPAC-MSC-PL is derived from ethically consented placental tissue.

Post-Thaw Viability
The percentage of viable cells remaining after a cryopreserved product is thawed using a defined protocol. A standard release criterion on Certificates of Analysis for frozen cell products and a primary determinant of downstream assay quality.

Potency Assay
A quantitative measure of the biological activity of a cell therapy product, required for lot release. For cell therapies, potency assays often measure cytotoxicity, cytokine release, or surface marker function depending on the mechanism of action.

R

RUO (Research Use Only)
Products intended for laboratory research purposes only, not for use in diagnostic procedures or therapeutic applications. RUO products have fewer regulatory requirements than GMP-grade materials but must still meet quality standards.

RUO-to-GMP Transition
The progression from research-grade to clinical-grade materials during the development of a cell therapy. OrganaBio enables seamless RUO-to-GMP transition by using the same donors, SOPs, and team from early research through clinical manufacturing.

S

Starting Material
The biological raw material from which a cell therapy product is manufactured. Common starting materials include leukopaks, cord blood units, and tissue-derived cells. The quality of starting material directly impacts the quality and consistency of the final product.

T

T Cell
A type of lymphocyte central to adaptive immunity. T cells are the basis for CAR-T therapy and play essential roles in immune responses. Different T cell subsets (CD4+ helper, CD8+ cytotoxic) serve different functions.

Tissue Collection
The procurement of biological tissues (such as umbilical cord, placenta, and cord blood) from consenting donors. OrganaBio’s subsidiary GaiaGift manages tissue collection through partnerships with hospitals and OB/GYN practices.

TCR Engineering
A cell therapy modality in which T cells are engineered to express a defined T cell receptor that recognizes a tumor-associated peptide presented by HLA. Requires HLA-matched patients and high-resolution HLA typing of starting material across HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1.

Tregs (Regulatory T Cells)
A subset of CD4+ T cells characterized by high CD25 and FOXP3 expression, responsible for immune tolerance and suppression of autoreactive responses. Used in autoimmune disease therapy development and graft-versus-host disease research.

U

Umbilical Cord Tissue
The structural tissue of the umbilical cord, primarily Wharton’s jelly, used as a source of mesenchymal stromal cells. Collected at birth under IRB-approved consent and processed into tissue-derived MSC products. OrganaBio’s MesenPAC-MSC-UC is derived from umbilical cord tissue collected through the GaiaGift subsidiary.

V

Vertical Integration
A business model where a company owns and operates multiple stages of its supply chain. OrganaBio is vertically integrated from donor recruitment (HemaCenter, GaiaGift) through collection, processing, manufacturing, analytical testing, and logistics, maintaining a single chain of custody and quality system throughout.

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Andrew Larson

Managing Director, CPC Services

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

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

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

Michael Dee

Associate Director, QC and Analytical Development

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

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

Meram Alamoudi

Senior Cell Processing Specialist

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

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

Valeria Beckhoff-Ferrero

Senior Bioprocess Scientist

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

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

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

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

Marisa Reinoso

Director, Regional Scientific Sales

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

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

Thelma Cela

Senior Director, Tissue Procurement

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

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

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

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

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

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

Dominic Mancini

Vice President, Operations

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

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

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

Christopher B. Goodman

Vice President, Quality & Regulatory Affairs

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

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

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

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

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

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

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

Danielle Smyla

Senior Director, Quality Assurance

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

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

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

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

Priya Baraniak, Ph.D.

Chief Business Officer

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

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

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

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

Sarah Alter, Ph.D.

Lab Director

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

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

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

Carlos Carballosa, Ph.D

Vice President, Sales

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

Oscar Robles

Director, Quality Systems

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