News & Insights
By Larry Pitcher, Chief Operating Officer, and Melodie Bryce, VP, Global Head of Quality, Kincell Bio
Quality First is more than a slogan for Kincell Bio; it is the foundation of how we lead, operate, and deliver for our partners and their patients. In a sector where speed to clinic matters, but product integrity matters more, quality must not be a gatekeeper at the end of the process; it must be a co-architect from the start.
As the operational and quality leaders of the organization, we are proud to lead collaborative and directly aligned operations and quality teams. We don’t view quality as a silo or a compliance hurdle; we view it as a strategic enabler. Together, we jointly lead the organization with a shared mission: to accelerate access to safe, effective, and life-changing cell therapies without compromising patient safety or regulatory excellence.
A Unified Approach to De-Risking Development
We understand what’s at stake for our clients: patient lives, investor confidence, and years of scientific innovation. That’s why we proactively invest in understanding each sponsor’s CMC strategy, product profile, and long-term clinical and commercial aspirations from the outset. Our quality and operations functions are integrated to help our clients navigate regulatory expectations, scale safely, and avoid common pitfalls in late-phase development.
By embedding right-sized controls, phase-appropriate rigor, and forward-looking quality infrastructure into each program, we strive to de-risk development as an integral part of our approach.
Whether supporting first-in-human trials or late-phase pivotal supply, we ensure programs are built on a strong foundation of science, compliance, and patient safety. This proactive, integrated approach helps our clients avoid costly delays and get therapies to patients faster, with confidence.
PAI Readiness as a Culture, not a Checkbox
Our multi-phase, multi-year Pre-Approval Inspection (PAI) readiness program exemplifies our quality-first mindset. Already well underway, this initiative is not about preparing for a single event. Instead, it’s about building a culture of inspection readiness and operational excellence that supports reliable, compliant, and scalable manufacturing.
Key Elements of This Program Include:
- A comprehensive update of our quality manual and core policies
- Mapping and aligning SOPs across all GxP functions
- A structured gap assessment and risk-ranking process
- Systematic closure of current and historical gaps with defined ownership
- Enhanced training and capability building for all staff
- Strengthening data integrity, deviation management, and CAPA effectiveness
We’re setting a high bar, not because it’s required, but because it’s the right thing to do for our partners, our employees, and ultimately, for patients.
Led by Experience, Built for the Future
Our leadership team has a proven track record of supporting companies through their product life cycles, including commercial approval and launch. From IND to BLA, from clinical startup to late-phase readiness, we’ve led CDMO teams through inspections by global regulators for advanced therapies and complex biologics. That depth of experience, earned by close collaboration with customers, shapes how we train our teams, structure our programs, and proactively engage with partners to de-risk their development path. When clients choose Kincell, they’re not just getting a manufacturing site; they’re gaining a strategic ally with the operational and quality maturity to help them succeed at every stage of development.
Built for Partnership, Committed to the Patient
The therapies we support have the potential to transform lives. We never lose sight of that. That’s why we hold ourselves and each other to the highest standards.
At Kincell Bio, quality leads and operations deliver. Together, we reduce development risk and accelerate progress because every day matters to the patients we serve.
