Services
Articles
Avoiding CMC Pitfalls: Keep Cell Therapy Programs on Track
In this featured article from Cell & Gene Therapy Review, Roger Herr, PhD, discusses common CMC pitfalls and shares practical strategies for...
Efficiently Transfer Programs Into Our Facilities at Any Stage of Your Product’s Lifecycle
Leveraging our 8-point tech transfer playbook, Kincell Bio mitigates risks and maintains program momentum when transferring processes into our facilities. The Gainesville, FL facility supports early-phase CMC activities, while our Research Triangle Park, NC site is optimized for pivotal studies and commercial manufacturing. Together, these facilities ensure smooth process integration, scalable manufacturing readiness, and continuity from early clinical development through commercial production.
8-Point Tech Transfer Playbook Reduces Risks & Keeps Programs on Track
Our structured tech transfer playbook ensures smooth program transitions by aligning timelines, transferring knowledge, validating processes, and confirming analytical readiness, reducing risk while maintaining momentum toward clinical, pivotal, and commercial manufacturing milestones.
Our tech transfer roadmaps are developed in partnership with our customers at the outset to define roles and responsibilities, timelines, budgets, and milestones, ensuring a smooth, on-schedule program.
We complete a thorough risk assessment to identify equipment and process differences, critical process parameters (CPPs), critical quality attributes (CQAs) analyses, analytical readiness, completeness of standard operating procedures, training requirements, and overall information sufficiency.
Transfer comprehensive documentation, including detailed process descriptions, CPPs, CQAs, raw material specifications, and analytical methods.
Perform small-scale runs to practice, identify potential issues, and optimize the process.
Execute GMP-compliant manufacturing runs to demonstrate process consistency, reproducibility, and compliance with specifications.
Producing commercial batches allows our team to identify any process issues at scale and produce product for stability studies.
Stability studies confirm that the cell therapy maintains CQAs throughout storage and shipping.
Scale-up data confirms CPP/CQA ranges, supports regulatory filings and process validations, ensuring an on-time launch.
Facilities & Teams Supporting the Entire Product Lifecycle
Kincell provides development and manufacturing services across the full cell therapy lifecycle, with our Gainesville, FL, USA facility focused on early CMC and clinical supply, and our Research Triangle Park, NC, USA facility emphasizing pivotal and commercial manufacturing. Together, the two facilities provide scalable and redundant GMP capacity, robust analytics, and expansion-ready infrastructure, allowing us to transfer programs in at any phase of the development journey.
Bringing Cell Therapy Discoveries to Life
Kincell Bio develops and delivers tomorrow’s cell therapy cures by integrating comprehensive, end-to-end capabilities across the full product lifecycle, with deep expertise spanning a broad range of autologous and allogeneic cell therapy modalities.
Integrated Services
Articles
Why a Strong CMC Roadmap Is Essential for Cell Therapy Program Success
While the curative potential of cell therapies is incredible, the path from a promising candidate in the lab to an approved therapy...
Videos
Turning Promise Into Cures
In this video, hear how Kincell Bio’s team balances speed, quality, and collaboration, from pre-IND development to the moment a patient is...
Talk to an expert
Turning Cell Therapy Innovation Into Patient Impact
Leveraging our science-first expertise and right-first-time quality, partner with Kincell Bio to advance your cell therapy from concept to commercialization.
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