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EV Workflow Solutions Designed for GMP Compliant Scale Up
GMP aligned EV isolation and characterisation workflows supporting batch to batch consistency across Singapore, Thailand, and Malaysia.
Supporting EV Translation from Research to Clinical Readiness
Translating extracellular vesicles into diagnostics and therapeutics requires more than proof of concept data. It requires reproducible, scalable, and GMP aligned workflows that preserve EV integrity while supporting regulatory progression and batch to batch consistency.
Atlantis Bioscience supports EV translation by combining GMP aligned technologies with practical GMP consultation, helping research and manufacturing teams design workflows that deliver consistent, reproducible outcomes across development stages. We support EV programmes across Singapore, Thailand, and Malaysia, working closely with translational laboratories, core facilities, CDMOs, and GMP ready manufacturers.
A Modular GMP Aligned EV Isolation and Charaterisation
Our EV bioprocessing workflows are modular and scalable, allowing programmes to progress from early research optimisation through to GMP aligned production. Each stage is supported by workflow consultation and technology selection, ensuring reproducibility, process robustness, and batch to batch consistency as sample volumes increase.
EV Isolation
qEV Size Exclusion Chromatography Columns
qEV columns use size exclusion chromatography to gently and reproducibly separate EVs from proteins and soluble contaminants. For GMP applications, qEV columns can be produced with bioburden and endotoxin testing, supported by defined batch release criteria and regulatory documentation.
Key benefits include:
- Consistent EV purity across batches
- Gentle isolation preserving EV structure and functionality
- GMP ready production available on request
- Scalable formats from research to clinical workflows
qEV Tangential Flow Filtration
Scalable Concentration with GMP Considerations
qEV Tangential Flow Filtration systems enable controlled concentration of EV samples before and after purification. Designed to integrate with qEV size exclusion workflows, qEV TFF supports process scale up while maintaining EV recovery and integrity.
GMP aligned configurations are available, with validated fluid contact components and software designed to support regulatory compliance, including alignment with 21 CFR Part 11.
Typical applications include:
- Concentration of conditioned media prior to SEC
- Buffer exchange and volume reduction
- Process control during translational and manufacturing scale up
qEV Zenco
Large Volume, Scalable EV Isolation
qEV Zenco supports automated EV isolation using larger qEV columns such as qEV10, qEV100, and custom formats, enabling industrial scale purification.
This platform is designed for environments where throughput, reproducibility, and operational robustness are essential.
Ideal users include:
- Core facilities supporting multiple EV programmes
- Translational and therapeutic EV researchers
- CDMOs and GMP ready manufacturers
Common applications include therapeutic EV production, process scale up, and purification from large volume sources such as conditioned media or milk.
qEV Dxter
High Throughput EV Isolation for Multi Sample Studies
qEV Dxter enables parallel processing of multiple qEV columns, supporting high throughput EV isolation while maintaining consistent SEC based purity.
Capabilities include:
- Simultaneous processing of up to 12 qEVoriginal or qEV1 columns
- Simultaneous processing of up to 24 qEVsingle columns
qEV Dxter is widely used in biomarker discovery, diagnostic development, and multi cohort studies, where standardisation across samples is essential.
EV and Nanoparticle Characterisation
Exoid TRPS
Reproducible Measurement of Size, Concentration, and Zeta Potential
Exoid TRPS enables simultaneous measurement of particle size, concentration, and zeta potential using just 35 µL of sample, with results generated in under 20 minutes including calibration steps.
Key benefits include:
- Detection of particles below 40 nm beyond conventional flow cytometry limits
- Lower sample consumption compared to DLS
- Zeta potential measurement for formulation and stability studies
- Compact footprint suitable for GMP and research laboratories
- Cost-effective alternative to nanoFCM
These capabilities support batch to batch comparability in both research and GMP aligned environments.
Who These GMP Aligned EV Workflows Are For
These workflows support:
- Translational and therapeutic EV researchers
- Core facilities and shared infrastructure platforms
- Diagnostic developers and biomarker discovery teams
- CDMOs and GMP ready manufacturers
- Drug delivery and formulation scientists focused on stability and reproducibility
How Atlantis Bioscience Supports EV Translation
Atlantis Bioscience is the official distributor of Izon Science in Singapore, Thailand and Malaysia. We work closely with research and manufacturing teams to design, implement, and scale EV workflows that align with both scientific goals and GMP expectations.
Our support combines:
- Access to GMP-aligned EV isolation and characterisation technologies
- GMP consultation focused on bioprocessing workflow alignment and scale-up readiness
- End to end EV workflow support from upstream cell culture to downstream evaluation in preclinical animal models
- Guidance on reproducibility, batch consistency, and quality control planning
- Regional technical and consultative support across Singapore, Thailand, and Malaysia
Beyond workflow implementation, Atlantis Bioscience shares practical guidance on regulatory considerations for exosome based therapeutics and emerging trends influencing the biotechnology landscape. Read articles below:
Plan Your GMP Aligned EV Workflow
Speak with Atlantis Bioscience to discuss how your EV bioprocessing can move from experimental workflows to reproducible, scalable, and GMP-aligned processes, supported locally across Southeast Asia.
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