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For cell therapy developers, early-phase speed without a clear CMC roadmap is extremely risky; however, overengineering early-phase work is too slow and costly. The programs most likely to successfully reach the market are those that allow their partnerships with their CMC organizations (or CDMO), a key scientific collaborator, to evolve as deliberately as the product itself, widening the circle of contributors and deepening rigor at every stage.
The Strategic Role of Leading Cell Therapy CDMOs
For many years, innovators working with simpler drug products relied on their CDMO partners primarily for capacity and cost efficiency. The relationship was largely transactional, and developers transferred their analytical methods and manufacturing processes to service providers that executed the defined protocols.
Given the growth of complex, advanced therapeutics, such as cell therapies, this model has evolved dramatically, with CDMOs becoming true strategic partners that provide the specialized expertise needed to succeed in the market.
The Value of a Specialized Cell Therapy CDMO
As a CDMO dedicated exclusively to cell therapies, Kincell Bio plays a critical role in helping our innovator clients translate their scientific breakthroughs into clinical and commercial realities. Cell therapies are inherently complex, as they are living products with variable biology, require intricate manufacturing steps, complex release testing paradigms, and are subject to rapidly evolving regulatory expectations. Partnering with Kincell provides innovators with access to the infrastructure, expertise, technology know-how, flexible capacity, and quality systems necessary to advance cell therapy programs effectively.
The benefits we bring to the table include end-to-end capabilities spanning process and analytical development, GMP manufacturing, quality control, regulatory support, and supply chain management. This integrated model allows developers to focus on advancing the science while relying on a proven framework for reproducibility, scalability, and compliance.
In addition to technical execution, we provide strategic guidance informed by experience across multiple clients and cell therapy types. The learnings from solving problems encountered in this complex set of cell therapy modalities compound with each batch, campaign, and client. This cross-program perspective accelerates problem-solving and helps innovators avoid costly missteps that can delay approvals. Ultimately, as a trusted CDMO, we extend a developer’s capabilities, turning complexity into control and enabling the development of safe, consistent, and commercially viable therapies.
Setting the Stage for a Successful Program
Effective partnerships begin long before tech transfer packages change hands. In early conversations, we align with our innovator clients on the therapy’s intent, understand the mechanisms of action, and identify the areas of most significant variability, ultimately seeking to mitigate CMC risk.
At this stage, our approach is not a defined “recipe.” Instead, we generally establish a series of hypotheses, including preliminary critical quality attributes (CQAs), an anticipated analytical program, and risk-ranked unit operations. We then work to convert our clients’ cutting-edge research into well-constructed processes using access to emerging technology and phase-appropriate approaches while keeping later phases of development at the forefront of our minds.
How the CDMO-Developer Relationship Evolves as the Program Advances
Our relationships with clients transform significantly over the course of a program, evolving into fully integrated strategic partnerships. Early collaboration typically focuses on translating an academic or discovery-stage process into a reproducible, GMP-compliant framework.
However, as the cell therapy advances into clinical development, the partnership deepens. Together with our client, we work to optimize processes, strengthen analytical methods, and build robust comparability and change control strategies that align with regulatory expectations. We also support documentation, stability programs, and scale-up planning, ensuring processes mature effectively. Ultimately, we aim to foster a relationship founded on mutual respect, open communication, and a shared goal of making these therapies accessible to clinicians who can utilize them to the benefit of patients.
By late-stage and commercial readiness, the relationship becomes one of shared ownership and accountability. By this point, we are fully functioning as an extension of the sponsor’s internal organization, jointly managing supply chain logistics, quality systems, and pre-approval inspection readiness.
What began as a technical transfer evolves into a unified partnership built on shared knowledge, continuous improvement, and a joint commitment to delivering safe, effective therapies to patients.
Kincell Bio is Building a Better Cell Therapy CDMO
“There’s a lot of great science out there,” Bruce Thompson, Chief Technology Officer at Kincell Bio, commented as he reflected on Kincell Bio’s growing strength in the market. “Cell therapies are a very complicated modality, so the fact that our scientific leadership team has been on the developer side and is now helping other developers is incredibly valuable. We’re often asked to accelerate or take exceptional risks to help companies get back onto a previously committed timeline. While we cannot always accommodate these requests, we’ve built an organization that includes the needed technologies, expertise, capability, and operational infrastructure to support the needs of these programs to get them to the next milestone in CMC development.”
Leveraging the strategically built organization, Kincell Bio is helping academic spin-out clients, as well as biotechs, realize the promise of cell therapies for patients worldwide. The Kincell team would be thrilled to determine if we can be of value to your program. Please don’t hesitate to contact us.
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Bruce Thompson, PhD
Chief Technology Officer
Bruce Thompson, PhD, is Chief Technology Officer at Kincell Bio, bringing more than 28 years of experience in cell and gene therapy development and manufacturing. He was the founding CEO of Kincell, where he built the technical and operations team and launched the company’s CDMO offerings. Previously, he held leadership roles at Resilience, Lyell Immunopharma, and Fred Hutchinson Cancer Research Center, where he led GMP manufacturing for multiple active clinical programs and supported six IND filings. Earlier in his career, Bruce spent nearly a decade at Pfizer in Pharmaceutical Sciences. He holds a B.A. in Biology, an M.S. in Biochemistry from The Ohio State University, and a Ph.D. in Microbiology and Immunology from the University of Louisville.
