GMP-Ready Analytical Development
At Cell-Easy, we help you implement analytical development and quality control strategies for your cell therapy programs that meet both regulatory and scientific requirements.
From early exploratory assays to fully GMP-qualified testing, we focus on generating reliable data to support decision-making at every stage. We work with you to select the right assays, qualify methods, and anticipate regulatory expectations.
Analytical Development Track Record in Figures
50+
Assays Developed
6-12 weeks
Method qualification
Rapid
On-site QC
Our Approach: Phase-Appropriate Analytical Development
Robust analytical data is key for both regulatory submissions and clinical progression. We handle every step, ensuring assays are fully qualified, reproducible, and aligned with international standards.
We perform all key Quality Control assays directly in our GMP laboratory, providing an integrated solution without the need for external partners.
Want to understand how analytical methods evolve from early exploratory assays to fully validated, GMP-ready methods? Read our guide: Navigating Assay Validation in Cell Therapy.
Tailored Analytical Method Development
We create assays tailored to your therapy’s unique characteristics to fully understand your product.
- Extended CQA/PQA characterization for a comprehensive assessment of product attributes.
- Flow cytometry for cell identity and phenotype characterization.
- qPCR and dPCR for gene expression and transgene analysis.
- ELISA and Ella for protein quantification.
- Cell-based potency assays including ICC, CFUs, MLRs, tumorigenicity, and more.
- Binding assays and in vitro bioassays to assess functional activity.
Note: This list is not exhaustive; additional methods can be developed according to your program’s needs.
What you gain:Analytical coverage that reduces regulatory gaps, ensures batch consistency, and provides reliable data to guide early development decisions.
GMP Method Transfer & Qualification
We ensure that your analytical methods are validated, transferable, and fully aligned with GMP standards.
- Seamless transfer of assays developed at your lab, a partner lab, or at Cell-Easy into our GMP QC environment.
- Method qualification aligned with GMP standards and reproducibility requirements.
- Comparability studies and site-to-site reproducibility to de-risk scale-up and clinical manufacturing.
- Potency assays and product characterization confirming batch consistency and functional activity.
What you gain: Qualified, transferable methods that minimize delays in clinical batches, ensure regulatory compliance, and support smooth progression toward GMP production.
Your Analytical Development Partner for cell therapies
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 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 cell therapy meets international standards at every stage.
Discover more about our services
GMP Cell Banking
GMP manufacturing
Process Development