Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform
By Todd Kapp and Brendan Lucey, Kivi Bio
Allogeneic cell therapy promises to reshape regenerative medicine by delivering scalable off-the-shelf treatments. Most existing cell therapies are very complicated and time consuming to make. Allogeneic cell therapy allows the use of a single donor’s cell to produce all of the medicine ahead of time, but it is still very early in modernizing these processes. The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.
Despite advances in automation, donor cell standardization, and regulatory science, manufacturing remains fragmented, inconsistent, and economically misaligned. With only two early successes on the market, Ryooncil by Mesoblast for the treatment of pediatric SR-aGvHD, and Omisirge by Gamida for hematologic malignancies, there is still quite a bit to be learned.
This column examines the most pressing barriers to platformization and outlines a path forward. Drawing on lessons from bioprocessing and cell and gene therapy, it argues that platform manufacturing is not merely a technical challenge — it’s a strategic imperative.
Context And Evolution Of The Allogeneic Cell Therapy Platform
Autologous therapies have demonstrated clinical success, but their individualized workflows expose deep inefficiencies in cost, logistics, and turnaround time. Allogeneic approaches, derived from healthy donor cells and designed for universal application, offer a more scalable model. However, the transition from bespoke production to standardized platforms is complex.
Unlike autologous manufacturing where time to patient is crucial, allogenic therapy allows more time for more manipulation of the cells, which may aid in the elusive ability to target solid tumors due to the immunosuppressive microenvironment that must be overcome. Regulatory frameworks are still adapting to the nuances of living cell products. Manufacturing infrastructure, often retrofitted from legacy systems, struggles to meet the demands of sterility, scalability, and automation. Unlike monoclonal antibody production, cell therapy lacks a mature platform model. To bridge this gap, the industry must confront a series of interdependent challenges across biology, engineering, compliance, and economics.
Core Challenges To Platformization
Donor variability and cell source standardization
Though starting with the big advantage that these cells come from healthy patients, biological variability remains a fundamental obstacle. Even with rigorous donor screening, inconsistencies in potency, viability, and immunogenicity can derail downstream processing. Establishing robust cell banks, implementing genomic and phenotypic profiling, and defining clear release criteria are essential to achieving consistency.
Manufacturing infrastructure and automation
Most facilities are not designed for high-throughput, modular production. Closed-system bioreactors, automated fill/finish platforms, and digital batch records are emerging but not yet ubiquitous. In addition, this may be an area where continuous manufacturing could play an important role in reducing production facility size and minimizing waste and starting material use while increasing output. Purpose-built infrastructure that supports parallel processing and adaptive control systems is critical — not just for efficiency but for reproducibility and compliance.
Regulatory harmonization and quality control
Global regulatory bodies differ in their expectations for cell therapy characterization and release testing. Without harmonized standards, platform manufacturing remains a moving target. Industry consortia must collaborate with regulators to define universal benchmarks for identity, purity, potency, and safety by looking to the steps the biologics industry took as it matured its ability to produce blockbuster drugs. Quality control must evolve from reactive testing to predictive analytics.
Supply chain and cryopreservation logistics
The cold chain is a critical vulnerability. Cells must be cryopreserved, stored, and shipped under tightly controlled conditions. Inventory management, thawing protocols, and chain-of-custody tracking require sophisticated logistics and digital integration. Platform manufacturing demands not only consistency in production but reliability in distribution.
Economic models and reimbursement pathways
Even with technical hurdles addressed, economic viability remains uncertain. Payers are still grappling with how to reimburse cell therapies, especially when pricing models don’t align with manufacturing realities. Platformization could reduce cost per dose, but reimbursement frameworks must focus on value-based pricing and outcome tracking.
Persistent Obstacles
Innovation frequently outpaces infrastructure. New cell types, gene editing techniques, and delivery methods introduce complexity faster than systems can adapt. Without coordinated investment in training, compliance, and interoperability, platformization risks becoming a patchwork of incompatible solutions.
Despite progress, several obstacles continue to impede platform manufacturing. Promising therapies have stumbled during scale-up due to process deviations or regulatory delays. Collaboration across sectors remains fragmented, with innovators, regulators, and manufacturers often operating in silos.
Strategic Impact
Overcoming these challenges would be transformative. Platform manufacturing could enable faster clinical trial enrollment, broader patient access, and more predictable product quality. It would reduce cost per dose, streamline regulatory approval, and unlock new business models for therapy distribution.
Strategically, platformization positions the cell therapy industry to scale like biologics — leveraging economies of scale, global supply chains, and digital infrastructure. It also opens the door to hybrid models, where allogeneic therapies serve as a backbone for personalized enhancements. The future of cell therapy depends not just on scientific breakthroughs but on the operational systems that make them deliverable. Solving these issues could dramatically improve the lives of millions of people globally by providing them with off the shelf solutions.
About The Authors:
Todd Kapp is the founder and CEO of Kivi Bio, a demonstration and training center in Kenosha, Wisconsin, focused on bioprocessing, automation, and cross-sector innovation. He brings deep expertise in operational planning, compliance, and stakeholder engagement across the cell and gene and biomanufacturing sectors.
Brendan Lucey, the CCO of Kivi Bio, is a biologist with a focus on cell and gene therapies and AI. He's a board member of the Bio-Processing Systems Alliance (BPSA). Past roles include posts at Entegris, Sartorius, and Gemini Bio. He received his M.Sc. in population biology, evolution, and ecology from Emory University.