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Echo™-Cardio

GMP manufacturing platform for iPSC-derived cardiomyocytes

A proprietary stirred-tank suspension bioreactor process, validated across multiple cell lines, and established within a GMP manufacturing facility.

Echo-Cardio

The Echo™-Cardio manufacturing process

Producing cardiomyocytes suitable for clinical use requires a manufacturing process that is both biologically robust and GMP-compliant from the outset. Echo™-Cardio is built on a cytokine-free, stirred-tank suspension bioreactor process — industrialized end-to-end, from iPSC starting materials through to drug product release.

It consistently delivers ventricular-like cardiomyocytes with high purity and confirmed phenotype, providing the product consistency that clinical programs demand.

Case Study: Scalable manufacturing of iPSC-derived cardiomyocytes

Achieving high cardiac purity, robust viable cell yields, and a predominantly ventricular-like phenotype through controlled 3D bioprocessing, a rational scale-up strategy, and close monitoring of critical process parameters.

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Accelerate speed to clinic through a pre-established, iPSC-based GMP manufacturing platform

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Secure clear IP positioning and licensing framework

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Boost scalability using stirred-tank bioreactors

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Reduce process and analytical development challenges with pre-built platform and pre-established starting materials

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Ensure regulatory readiness and GMP compliance at our EMA-certified, and FDA and PMDA-compliant manufacturing facility

Manufacturing Partner

Work with a proven cardiomyocyte manufacturing partner, with more than 500 batches executed across 53 iPSC lines

Giving you an edge from start to finish.

Echo™-Cardio puts all the right services and modules to work right where they can benefit your program the most. From iPSC starting materials through to IND/IMPD-ready CMC documentation, we help you take every step in GMP manufacturing confidently and productively. 

Qualified iPSC starting materials

Manufacturing starts from pre-established GMP iPSC master cell banks (MCBs).
  • Genomic stability, low-passage lines, and full traceability
  • Long-term supply security
  • Optional integration of client-specific edits via Pulse™ and STAR-CRISPR™

Scalable 3D bioreactor expansion

  • Controlled, reproducible expansion in automated stirred-tank bioreactors
  • Clinical-scale output exceeding 20B cells per batch
  • Consistent viability, purity, and phenotype maintained across scale

Standardized, GMP-aligned differentiation

  • Cytokine-free, chemically defined workflows
  • Line-agnostic design supporting client-supplied iPSC lines
  • Closed, automated systems minimizing variability
  • Pre-established batch records and qualified GMP raw materials
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Support in perfect rhythm with your program.

Bringing a cardio-focused cell therapy or regenerative medicine to market is a team effort. And through Echo™-Cardio, we’re the kind of teammates that can deliver – on time, in full, and in perfect alignment with your program’s most critical development and manufacturing goals. Discover how today.

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What you get with Echo™-Cardio.

When you deploy Echo™-Cardio for your program, you get GMP-Manufactured Cardiomyocytes delivered at scales suitable for Phase I clinical studies, with consistent phenotype and stable functional performance. More important, you get the benefit of the full expertise and experience of a scientific team that has 15+ years focused exclusively on iPSCs.

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High-quality, functional cell material

  • 90% purity with strong expression of canonical cardiac markers
  • Physiologically relevant AP morphology, conduction, contractility, and calcium handling
  • Reproducible maturity features: beat regularity, pacing compatibility, and stable electrophysiology
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Comprehensive documentation package

  • Certificates of Analysis
  • Batch records and full traceability
  • QC release panel
  • Regulatory-ready CMC documentation supporting IND/IMPD submissions
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Integrated IP framework

Direct access to STAR-CRISPR™, Allo Chassis™, and Cellistic's Echo™ manufacturing platform with no third-party dependencies.

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Consistent, reproducible output

All Echo™-Cardio batches are produced with tight biological variability control and full cGMP compliance for translational and clinical programs.

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A platform with the muscle to deliver at scale.

Echo™-Cardio is designed to provide the manufacturing heartbeat of your iPSC-based regenerative medicine program. And it comes exclusively from a CDMO with the expertise to keep it all beating in perfect sync from start to finish. Let’s find out together if Echo™-Cardio could be a good fit for you.