GMP Cell Banking Services (MCB/WCB)
Cell banking is the foundation of any cell therapy, and we make sure yours is solid. At Cell-Easy, we help you design, establish, and maintain Primary (PCB), Master (MCB), and Working Cell Banks (WCB) under strict ICH Q5D and cGMP guidelines.
Our team ensures your cells are well-characterized, traceable, and ready for research or clinical use. Whether you need a one-off Master Cell Bank or a full GMP cell banking services program from strategy to long-term storage, our team supports biotechs, academic labs, and pharma companies at every stage.
Cell Banking Track Record in Figures
30+
Cell banking projects
20+
In-house analytical assays
17
EU ans US companies provided
Our Approach: Building Reliable, GMP-Compliant Cell Banks for Consistent Therapy Supply
A robust cell bank secures your therapy’s foundation and reduces regulatory and operational risks. We design, generate, and maintain your cell banks with full scientific and regulatory compliance.
Cell Banking Strategy & Process Diagnostics
We begin by assessing your cell line and defining a compliant banking strategy aligned with your clinical roadmap.
- Cell line review and planning assessing history, intended use, and regulatory requirements to define a compliant and efficient banking approach.
- Tailored banking strategy aligned with your clinical roadmap to anticipate risks and secure early regulatory alignment.
- Regulatory documentation prepared according to EMA, FDA, and MHRA expectations, including Certificates of Analysis, QC reports, and supporting documents for IND/IMPD submissions.
What you gain: A compliant, risk-aware strategy that reduces regulatory delays and ensures your cell bank is ready for clinical progression from day one.
GMP Cell Bank Generation (PCB, MCB, WCB)
We generate and maintain your cell banks under GMP conditions while ensuring full quality control and biosafety.
- Expansion & cryopreservation to create Primary (PCB), Master (MCB), and Working Cell Banks (WCB) under GMP-controlled conditions.
- Flexible batch sizes ranging from 1 mL vials to 50 L lots , matching research and clinical needs.
- Integrated QC testing including in-process and release assays fully embedded in the workflow to ensure consistency and regulatory compliance.
- Comprehensive safety testing including sterility, endotoxin, mycoplasma, and adventitious agent assays to ensure biosafety.
- Identity, purity, and post-thaw performance evaluations verifying viability and functionality.
What you gain: Stable, reproducible cell banks that guarantee biosafety, consistent performance, and accelerate readiness for clinical manufacturing.
Cell Bank Fill, Finish & Long-Term Storage
We manage packaging and storage to maintain viability and potency throughout the therapy lifecycle.
- Up to 500 pharmaceutical-grade vials with a tailored Fill & Finish strategy and controlled-rate freezing to minimize exposure to cryopreservation solutions and ensure cell viability before storage.
- Long-term cryostorage in gaseous-phase liquid nitrogen.
What you gain: Reliable long-term availability of your cells, preserving potency and ensuring uninterrupted progress through all development and clinical phases.
Your Partner for GMP Cell Banking Services
When you work with Cell-Easy, you’re not just outsourcing to a CDMO, you’re teaming up.
We become an extension of your team, fully committed to helping your cell therapy reach patients safely, efficiently, and on schedule.
- Dedicated support for your therapy: We make sure you have clarity every step of the way with weekly updates, quarterly strategic reviews with a senior leader, and a dedicated project manager guiding your project.
- Proven track record: We have supported over 30 cell banking projects, demonstrating consistent results.
- Transparent collaboration: Through clear planning and Go/NoGo assessments, we keep your project on track without surprises.
- Accelerated IND/IMPD support: Our approach can shorten submission timelines by up to three months.
- Regulatory compliance & traceability: We ensure that your cell therapy meets international standards at every stage.
Ready to secure your therapy’s foundation with a reliable GMP cell bank services partner?
Discover more about our services
Process Development
GMP manufacturing
Analytical Development