The CDMO built to take your cell therapy mainstream.
From early development, we help cell therapy innovators build beyond technical success. Our iPSC-first approach is designed to reduce avoidable redevelopment and create a clearer path to scalable GMP manufacturing.
Execution built on pre-established platforms
We use pre-established platforms, fit-for-purpose process design, and manufacturing know-how to help programs move forward with greater speed, consistency, and fewer repeated development steps.
Deep expertise in iPSC-derived cell therapies
From pluripotency through differentiation and characterization, we help partners navigate the specific demands of iPSC-derived cell therapies and translate that complexity into robust, scalable processes.
Commercial thinking embedded early
Manufacturability, analytical control, scale, and cost are considered from the outset - creating the conditions for industrialization and helping build a stronger foundation for GMP manufacturing and long-term commercial viability
Start-to-finish support for your cell therapy begins here.
From early development through GMP manufacturing, we help turning promising programs into robust, scalable and commercially viable paths forward.
If you’re seeking a cell therapy CDMO partner with comprehensive capabilities, here’s a checklist to get you started. When you dig a layer deeper, you’ll also find that we have a unique ability to harness the power of iPSC-based programs to help you reach the real finish line: Commercial viability.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
The Echo-NK 2.0 offering is ideal for clients taking an iPSC-derived NK cell therapy to Phase I clinical trials.
Cell Line Development
With Cellistic's Pulse™ cell line development platform, you can go from idea to edited Master Cell Bank – saving time with our pre-built tools and focusing on key customizations that your specific program demands.
Cut timelines by 12+ months with iPSC cell line materials optimized for clinical readiness and manufacturing continuity.
Streamline development in an EMA-certified, FDA/PMDA-compliant facility that’s backed by 15+ years of iPSC and GMP manufacturing experience — and 100% program success rate.
Gain direct access to STAR-CRISPR™gene editing and Allo Chassis™ immune-cloaked iPSC cell lines without third-party licensing.
Cellistic develops, scales, and optimizes iPSC-derived cell therapy manufacturing processes to improve yield and ensure consistent purity, quality, and potency. Process development is designed for scalability, reproducibility, and GMP alignment—supporting efficient transition into manufacturing.
Process development pathways include:
Platform-led development: Clients leverage Cellistic’s Echo™ manufacturing platforms, with processes optimized for product-specific requirements.
Process transfer and optimization: Client processes—whether research-grade or fully established—are transferred to Cellistic and used as-is or further scaled, optimized, and adapted for GMP-compliant manufacturing.
De novo process development: New manufacturing processes are created using our development and manufacturing expertise, informed by the proven Cellistic Echo™ platforms and industrialized workflows.
Analytical Development
Analytical Development defines how we characterize cells throughout development and manufacturing. It sets the assay strategy needed to demonstrate that iPSC-derived cells match the intended phenotype and retain their expected mechanism of action and functionality. This includes selecting, developing, and qualifying release, in-process, and comparability assays.
Master Cell Banking
Our turnkey process for GMP master cell banking makes sure you’re ready when it’s time to go, with pre-qualified materials, rigorous quality control, genetic stability assessments, and comprehensive GMP documentation for your IND.
Leverage the efficiencies of established processes for testing the seed bank, manufacturing, cryopreservation, quality control and release.
Take advantage of deep cell bank characterization to ensure regulatory readiness under a GMP audited quality system.
Count on best-in-class culture conditions for the highest quality cells (with no exhaustion of cell lines after process development).
Scale as-needed with cell banking capacity for hundreds of vials of product.
Tech Transfer
When you tech transfer with Cellistic, you can be confident that there will be a controlled, sharply executed handoff of your process, materials, assays and knowledge into our Pulse and Cellistic Echo platforms. That holds true no matter what development stage your program is in.
GMP Manufacturing
Cellistic supports iPSC-derived cell therapy manufacturing from iPSC cell line to drug product through bioreactor-based, GMP-compliant processes in dedicated infrastructure.
Leverage pre-established platforms and processes, including GMP manufacturing approaches already tested at scale.
Our bioreactor-based Cellistic Echo platforms are designed to support product quality, scalability and cost-effectiveness.
Meet regulatory requirements with fully qualified materials following ICH guidelines, validated QC methods, and 10 years of manufacturing experience.
Advance your program in our Belgium-based facility exclusively dedicated to iPSC-based allogeneic cell therapy manufacturing, with a team of experts focused on your unique needs.
Our Quality Management System — designed following ATMP (Advanced Therapy Medicinal Product) Regulation — unites proven quality, operational, and support processes under a single framework for comprehensive, accountable performance.
Bring the benefit of agility front-and-center through a manufacturing facility designed and qualified specifically for iPSC-based cell therapy manufacturing.
Gain confidence from successful regular inspections — of both our manufacturing site and QMS — by EU Competent Authorities (CAs), operating under FDA.
Rely on manufacturing and import authorization (MIA) and GMP certification that authorize worldwide manufacture and export.
Connect with the CDMO built to turn your cell therapy opportunity into reality.
We’re ready for what’s next in your cell therapy development and manufacturing. Let’s start with a conversation about your most pressing needs, and how Cellistic is uniquely positioned to address them.
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