cdmo Archives - Kincell Bio

Multi-million-dollar investment in facility infrastructure, quality management, and enterprise systems positions Kincell Bio to support an increasing number of clients preparing for commercialization and to meet growing market demand in the cell therapy sector.

Research Triangle Park, NC — April 14, 2026 — Kincell Bio, a leading contract development and manufacturing organization (CDMO) supporting autologous and allogeneic cell therapy programs, today announced a significant strategic investment to expand and strengthen its Research Triangle Park (RTP), North Carolina, facility. The expansion reinforces Kincell Bio’s commitment to supporting clients as they advance from late-stage clinical CMC development through commercialization and post-approval life cycle management.

Expanding Capacity to Meet the Demands of a Maturing Industry

The RTP facility serves as Kincell Bio’s center of excellence for pivotal supply, commercialization, and commercial manufacturing, complementing its early-phase focused facility in Gainesville, Florida. The RTP site currently houses four ISO 7 cleanroom suites, and the expansion will enable the addition of two more suites, meaningfully increasing the facility’s capacity to support both autologous and allogeneic cell therapy programs at commercial scale.

“This expansion reflects our commitment to supporting our clients’ commercial success and our confidence in the trajectory of the overall cell therapy industry,” commented Larry Pitcher, Chief Executive Officer of Kincell Bio. “A number of our clients are preparing for commercialization, and these investments will ensure that our infrastructure is ready to support them at every stage of that journey.”

The build-out includes a comprehensive suite of supporting infrastructure designed to meet the rigorous demands of late-stage and commercial programs:

Additional QC Laboratory to support expanded quality control testing across a growing client portfolio
MSAT/ASAT Laboratory purpose-built to support later-stage process characterization, process validation, method validation, and technology transfer activities
Microbiology Laboratory equipped for rapid sterility testing, accelerating critical release timelines for autologous therapies, while also supporting allogeneic products.
Expanded GMP Warehouse providing significantly increased storage capacity to support growing late-phase clinical development and commercial supply needs
Administrative Expansion workspaces for over 100 team members, supporting our growing organization

The expanded facility is projected to be fully operational by the end of the third quarter of 2026.

Investing in Systems That Scale

Alongside the physical build-out, Kincell Bio is making complementary investments in the digital infrastructure required to support commercial-stage operations. Further investment in the organization’s Veeva quality management system will further streamline quality operations, enhance end-to-end visibility and control, and provide the scalability necessary as an increasing number of cell therapy products advance toward and enter the commercial market. Additionally, investment in the company’s enterprise resource planning (ERP) system will support end-to-end program and product management, ensuring operational efficiency keeps pace with growing client demand.

“Cell therapy demands the best in science, process execution, and partnership,” shared Bruce Thompson, PhD, President and Chief Technology Officer. “This expansion is a direct expression of our commitment to staying at the forefront of analytical technologies, process development, and manufacturing operations. We are strengthening the infrastructure today that will deliver transformative therapies to patients tomorrow.”

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC, and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, with expertise in analytical and process development and GMP manufacturing, testing, and release from early clinical, to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCRs, Tregs, and CAR-NK programs, and on developing expertise in stem cell products and iPSCs.

For more information, visit www.kincellbio.com, and follow us on LinkedIn.

Media Contact:

Stewart McNaull, PhD
Chief Commercial Officer
Kincell Bio, Inc.
Email: stewart.mcnaull233@kincellbio.com

Research Triangle Park, NC — Kincell Bio, a leading U.S. cell therapy contract development and manufacturing organization (CDMO), today announced a new collaboration with RegCell, a biotechnology company developing first‑in‑class immune tolerance platform based on epigenetically reprogrammed regulatory T cells (Tregs). Under the partnership, Kincell Bio will provide comprehensive CMC development and GMP manufacturing support to accelerate RegCell’s lead Treg program toward clinical trial evaluation.

As part of the collaboration, RegCell will transfer its lead Treg program to Kincell Bio for process and analytical transfer and development, optimization of a scalable manufacturing process, and GMP clinical material supply to support IND‑enabling activities and clinical trials. The collaboration is designed to streamline development timelines and ensure robust clinical supply for RegCell’s novel epigenetic reprogramming platform, aligning closely with Kincell’s mission to accelerate CMC development and clinical manufacturing for cell therapy innovators.

RegCell’s platform converts disease-driving CD4+ T cells into lineage-stable, antigen-matched Tregs by recapitulating critical epigenetic features involved in Treg imprinting and stability. RegCell was founded by Professor Shimon Sakaguchi, Distinguished Professor of Osaka University, Professor Emeritus of Kyoto University, who shared the 2025 Nobel Prize for Physiology or Medicine for his contributions to understanding immune tolerance and the role of Tregs. Notably, RegCell’s platform does not require gene editing or viral DNA reagents, substantially reducing manufacturing complexity and enabling automation and potential point-of-care access.

“Our relationship with Kincell Bio is a critical part of our US strategic plan and enables us to access leading capabilities in T-cell manufacturing, as well as to focus on creating a commercially viable manufacturing process at an early stage of clinical development,” said Michael McCullar, Ph.D., Chief Executive Officer of RegCell.

“I’m excited for Kincell Bio to support RegCell as they advance a deeply innovative therapeutic approach rooted in decades of foundational immunology,” said Bruce Thompson, PhD, President and Chief Technology Officer of Kincell Bio. “RegCell’s science represents a significant advancement in the treatment of autoimmune disorders, and our team is committed to providing the technical solutions and GMP execution required for clinical success.”

Kincell excels at CMC development and clinical supply for innovators by providing industry-leading process and analytical development, and early clinical and late-stage clinical cGMP manufacturing capabilities that are serving the needs of biotech and pharmaceutical companies. Kincell is committed to advancing the field of cell therapy with tailored solutions that empower innovators to bring their therapies to market efficiently and effectively.

“We are proud to partner with RegCell in advancing this groundbreaking new category of cell therapy,” said Larry Pitcher, Chief Executive Officer at Kincell Bio. “RegCell’s vision for restoring immune tolerance through precisely engineered Tregs aligns perfectly with Kincell’s mission to empower pioneering cell therapy developers with agile, reliable, and high‑quality CMC and manufacturing support.”

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC, and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, with expertise in analytical and process development and GMP manufacturing, testing and release from early clinical, to pivotal studies, and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCRs, Tregs, and CAR-NK programs, as well as developing expertise in stem cell products and iPSCs.

For more information, visit www.kincellbio.com, and follow us on LinkedIn.

About RegCell

RegCell is a global biotechnology company based in the U.S. and built on the pioneering discoveries of Co-Founder Professor Shimon Sakaguchi in regulatory T-cell biology. RegCell is pioneering cell therapies for autoimmune diseases and transplantation, with a first indication in autoimmune hepatitis. RegCell has developed a best-in-class proprietary platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs to restore antigen-specific immune tolerance. By addressing unknown or multiple pathogenic antigens, RegCell’s platform addresses key limitations that have thus far prevented the development of cell therapies for unmet needs in autoimmune diseases, which are typically managed with drugs that broadly suppress the immune system rather than target the underlying cause. RegCell’s approach does not require genetic modifications, allowing for simplified manufacturing, enhanced safety, and expanded scalability to address a broad spectrum of autoimmune patients. Driven by a vision to redefine self-tolerance, RegCell is committed to delivering safe, life-changing cell therapies that can reverse autoimmune disorders and overcome challenges in transplantation.

For more information, visit http://www.regcellbio.com/ and follow us on LinkedIn and Twitter.

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or Tierney Sovic, MSc
Russo Partners LLC
ignacio.guerrero-ros@russopartnersllc.com
tierney.sovic@russopartnersllc.com

Cell therapies hold curative potential, yet far too many patients still can’t access them. In many cases, these treatments aren’t pursued by developers because science is advancing faster than the systems that support it — from reimbursement policies and clinical research infrastructure to manufacturing costs and traditional pharmaceutical business models.

Rare and ultra-rare conditions underscore the urgent need to develop new therapeutic constructs. More than 10,000 rare diseases have been identified; 80% of these conditions are genetic, and only 5% of them have FDA-approved treatments to address them. In short, there are approximately 7,500 identified rare diseases, with patients awaiting solutions from the cell therapy community.

This gap highlights a significant opportunity: to expand the promise of cell therapy beyond its current narrow indications deeper into the rare disease space, and to eventually tackle widespread conditions such as diabetes and neurological disorders. Realizing the promise of cell therapy will require rethinking how we fund research, design reimbursement models, and scale manufacturing to make these therapies viable for smaller patient populations.

To dive deeper into these insights and perspectives, read the full article here.

Key Takeaways

Allogeneic cell therapies offer cost and efficiency advantages by decoupling manufacturing from individual patients, enabling faster availability and simpler logistics.
Automation in cell therapy manufacturing enhances consistency, reduces user error, and lowers training barriers, crucial for scaling up production.
Flexible manufacturing processes must balance regulatory requirements with the need for adaptability as therapies progress through clinical trials.
CDMOs are essential in addressing evolving manufacturing needs, offering expertise in diverse platforms and processes for both autologous and allogeneic therapies.

Check out the full article at BioPharm International.

Check out her article at BioProcess Online.

New contract reinforces Kincell Bio’s commitment to long-term partnerships to address development and GMP manufacturing support for engineered cellular therapies.

Gainesville, Florida (September 16, 2024) – Kincell Bio, a cell therapy-focused cGMP contract development and manufacturing organization (CDMO), today announced that it has welcomed a new client for the production of a cell therapy product to address degenerative disease.

The agreement represents a multi-year partnership to produce patient-specific batches of clinical-grade product at its site in Gainesville, Florida. The multi-year contract adds to the work for other clients already in progress at the site.

“We’re delighted to welcome another client to our Gainesville facility,” said Bruce Thompson, PhD., CEO of Kincell Bio. “Our facility is GMP-ready, and our team thrives on providing critical CMC development and manufacturing expertise to support our clients’ clinical development plans to help patients.”

The client is a clinical stage cell therapy company pursuing regenerative medicine in a variety of critical indications. This project reflects Kincell Bio’s expanding portfolio, reinforcing its position as a strong partner in the cell therapy CDMO space.

About Kincell Bio

Kincell Bio engineers cells into therapies. A technology-forward contract development and manufacturing organization (CDMO), Kincell has facilities in both Gainesville, FL and Durham, NC. Kincell was formed to streamline analytical development, process development, CMC consulting and early-stage through registrational GMP cell therapy manufacturing. For more information, visit www.kincellbio.com.

Business & Media Enquiries
Bruce Thompson, PhD
Chief Executive Officer
contactus@kincellbio.com

New contract reinforces Kincell Bio’s commitment to long-term partnerships to address development and GMP manufacturing support for engineered cellular therapies.

Durham, North Carolina (September 4, 2024) – Kincell Bio, a technology-forward cell therapy cGMP contract development and manufacturing organization (CDMO), today announced that it has welcomed a new partner for the production of early-phase clinical material of an allogeneic cell therapy product. This contract follows the acquisition of the GMP-ready facility in April 2024 and augments the manufacturing activities already occurring at the site. The agreement represents a multi-year relationship and strongly validates the team’s competency in allogeneic cell therapy production and release.

The partner is a leading biotechnology company known for pioneering advancements in novel biologic medicines. This collaboration underscores our shared commitment to driving innovation in the development and manufacturing of cutting-edge therapies aimed at addressing unmet medical needs.

“Kincell Bio continues to build meaningful partnerships with our customers, providing critical CMC development and manufacturing expertise to support their clinical trials”, said Bruce Thompson, PhD., CEO of Kincell Bio. “Our entire team is energized to support innovative approaches that help bring new cellular therapies to market and help patients.”

This new contract exemplifies Kincell Bio’s ongoing efforts to expand its portfolio of partnerships and enhance its manufacturing capabilities, reinforcing its position as a strong partner in the cell therapy CDMO space.

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell is a contract development and manufacturing organization (CDMO) situated in the Southeastern United States. Kincell Bio’s mission is to streamline CMC development, with expertise in analytical and process development and GMP manufacturing, testing and release. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs. For more information, visit www.kincellbio.com.

Business & Media Enquiries
Bruce Thompson, PhD
Chief Executive Officer
contactus@kincellbio.com

Check out the article at Cell & Gene.

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