OrganaBio is a vertically integrated CTDMO (Contract Technology Development and Manufacturing Organization) founded in 2018 in Miami, Florida, supplying clinical-grade leukopaks, PBMCs, mesenchymal stromal cells, and hematopoietic stem cells alongside cGMP manufacturing and clinical cell processing services for cell and gene therapy developers. OrganaBio is FDA-registered and operates ISO 7 cleanrooms with an AABB-accredited apheresis collection center.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
We work alongside your team to rapidly progress proof-of-concept or Phase I appropriate processes by scaling out, scaling up, and making the process cGMP ready. The OrganaBio team has ample experience with CliniMACS, AutoMACS, MultiMACS, manual magnets, Prodigy, Sepax, and Rotea, to name a few systems. We focus on robustness, reproducibility, and economies of scale while maintaining critical process parameters and critical quality attributes of the final drug product. Full transparency into batch records and other documentation facilitates tech transfer, cGMP manufacturing, and CMC for your IND.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
The OrganaBio team routinely performs assay development and analytical testing for customers utilizing its on-site analytical testing core equipped with qualified, state-of-the-art scientific equipment. Capabilities include: Cell enumeration; Cell viability; Stability, endotoxin, CBC, CPP and CQA testing; Immunophenotyping; Process Development for adoptive cell therapy; Data preparation and analysis for patent application; Cytotoxicity assays; ADCC assay development and analysis; Flow Cytometry- up to 25 color analysis; Cell culture –PBMC, lymphocytes, thymocytes, hybridomas, tumor cell line antibody production and quantification; PCR, RT-PCR; DNA/RNA extraction; Protein quantification; Assay platform technology transfer.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
OrganaBio’s centralized facility can manufacture, store, and distribute human cellular therapy products for clinical development and commercialization. The Facility and its manufactured products meet rigorous standards put forth by the Food and Drug Administration (FDA) as defined in 21 CFR Part 210 & 211 (cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Pharmaceuticals), 21 CFR Part 600, 601 & 610 (Regulations for Biologics), 21 CFR Part 1271 (Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products), and 21 CFR Part 820 (Quality System Regulation), to ensure product safety, quality, purity, potency, and effectiveness.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
All OrganaBio processes are governed by approved Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) to ensure consistency, traceability, and readiness for tech transfer to cGMP manufacture. Our Quality Control Testing Core team has developed validated protocols and practices to streamline the product release process to ensure product identity, safety, quality, and integrity. With extensive experience in a wide range of science disciplines, customers can leverage our reliable Quality Control Testing Core team to improve capabilities and operational standards.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
OrganaBio’s QA team has comprehensive capabilities to support cellular therapy product regulatory development and provide assistance with applicable Food and Drug Administration (FDA) and Institutional Review Board (IRB) submissions. OrganaBio has established solid working relationships with both the FDA and a recognized IRB, to support the application review process throughout various stages of product development. This translates into an efficient investigational product approval process.
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.
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.
Senior Cell Processing Specialist
Senior Bioprocess Scientist
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.
Senior Director, Tissue Procurement
Vice President, Operations
Vice President, Quality & Regulatory Affairs
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.
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.
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.
Vice President, Sales
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.
