Fast, Reliable GMP Cell Therapy Manufacturing

Producing ATMPs for the clinic can be complex, and we’re here to make it manageable. At Cell-Easy, we support your teams in producing clinical-grade GMP material that meets international standards (MHRA, EMA, FDA).Whether you’re preparing early clinical batches or planning larger-scale production, we focus on practical solutions that reduce risk, ensure reproducibility, and keep your program moving efficiently toward the clinic.

Let’s talk about your project

GMP operator in full PPE, seeding CellStack 10 with cells from the bag, containing the complete culture medium. - Cell-Easy

Our performance in figures

20+

GMP clinical
batches released

70+

Instruments &
Technologies used

10+

IND/IMPD
submission

Our Approach: GMP Manufacturing Designed for Clinical Readiness

Transitioning from development to GMP production involves multiple technical and regulatory steps. We make this process structured and predictable by providing flexible facilities, expert teams, and workflows aligned with global regulatory expectations.

Two operators preparing G-Rex 500M and its inoculation with the cell suspension from the bag (complete medium with cells). A connection between the bag tubing and the G-Rex 500M tubing is made aseptically in a biological safety cabinet (BSC). – Cell Easy

Cell Manufacturing Capacities

Your therapy needs a production environment that ensures reproducibility and safety at every scale.

Five multi-suite Grade B cleanrooms supporting both autologous and allogeneic therapies, including iPSC, hESC, T cells (modified and non-modified), NK cells (modified and non-modified), HSCs, MSCs, fibroblasts, and blood-derived cells.
Advanced and adaptable production platforms such as Cell Stack, G-Rex, Cocoon, CliniMACS, and Lovo…suitable for open or closed workflows
Pilot lots and early process optimization enabling CPP/CQA validation to reduce variability, maximize yield, and accelerate scale-up.
GMP-compliant workflows covering isolation, sorting, expansion, washing and volume reduction, ensuring consistent, high-quality cell processing.

What you gain: A flexible GMP environment that ensures reproducible, high-quality cell production while reducing operational and regulatory risks.

Cell Quality & Release

Quality is the foundation of everything we do. It’s what keeps your production on track and compliant.

On-site testing providing fast turnaround for cell counting (~3 weeks), endotoxin detection (~6 weeks), flow cytometry, qPCR, and stability assays.
Conditional release in 6 weeks so batch processing can move forward while final tests are completed.
Full release certification within 3–4 months, ensuring complete compliance and documentation.
Continuous monitoring and deviation management to maintain integrity throughout production.

What you gain: Fast, reliable QC with full traceability, enabling confident batch release and maintaining clinical timelines.

QP person reviewing GMP documentation and batch records in the cell easy office. This highlights the Qualified Person's (QP) role in regulatory compliance and final batch release. – Cell-Easy

An operator, wearing full Personal Protective Equipment (PPE) including cryogenic gloves and a face shield, loads a multi-layer rack into a Digitcool Controlled-Rate Freezer. – Cell Easy

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.
Coordinated release management to make sure every batch reaches clinical sites safely and on schedule.

What you gain: Secure, controlled storage and dependable delivery, so your cells remain potent and your program stays on schedule.

Your Partner for GMP Cell Therapy Manufacturing

When you work with Cell-Easy, you’re not just outsourcing, you’re teaming up.
We become an extension of your team, fully committed to helping your 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: 50+ analytical methods successfully implemented
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 therapies meet international standards at every stage.