Acoustic Cell Handling White Paper

for cell therapy manufacturing

Revolutionizing Cell Therapy Manufacturing: Acoustic Cell Handling Technologies

The cell and gene therapy industry faces a critical challenge: processing fragile, high-value cellular products at scale while maintaining stringent quality standards required for life-saving therapies.

As cell therapies move toward commercial production, manufacturers encounter a growing mismatch between product requirements and legacy processing tools. Fragile cells must now be handled under tighter GMP expectations with greater consistency, lower contamination risk and clearer process control.

Yet many downstream operations still rely on technologies originally developed for blood processing or research use. Centrifugation, filtration and manual handling can introduce mechanical stress, process variability, operator dependence and scale-up limitations at precisely the stage where robustness matters most.

Autologous and decentralized manufacturing models increasingly require smaller-footprint, modular and automation-ready solutions. In this environment, phase-appropriate equipment is becoming a strategic requirement.

Acoustic Cell Handling represents a paradigm shift from aggressive mechanical processing to scalable, gentle and precise cell manipulation. This purpose-built unit operation uses controlled ultrasonic waves to manipulate cells without physical contact. As regulatory expectations tighten and production volumes increase, acoustic cell handling emerges not as an alternative, but as the new standard for cell therapy manufacturing. Major industry players including Getinge and AcouSort are already embracing acoustofluidic technologies, recognizing their potential to revolutionize bioprocessing.

Acoustophoresis technology creates standing acoustic waves within specially designed flow channels. These waves generate radiation forces that guide cells to specific positions based on their physical properties – all while maintaining continuous flow and preserving cell integrity.

🔬 Gentleness

Non-contact processing preserves cell viability and functionality with no negative impact on sensitive cell lines. This eliminates the high G-forces and shear stress of centrifugation.

⚙️ Scale-up Ready

Fully closed, sterile system operation eliminates manual handling and human variability while seamlessly integrating with existing GMP workflows.

📈 Versatility

A single platform handles concentration, washing, and sorting operations. Process flow rates range from 1-50 mL/min, handling several liters daily with modular design scaling from research to commercial production.

✅ Regulatory Confidence

GMP-ready design features FDA-approved materials and comprehensive validation documentation for streamlined regulatory submissions.

Aenitis' technology demonstrates remarkable efficiency:

- Cell Concentration: Achieve 3x concentration factors per channel with >95% recovery rates

- Media Exchange: Remove >96% of original media in multi-stage washing

- Cell Sorting: Separate populations using innovative acoustic beads technology

- Gentleness: Maintain full viability and functionality across diverse cell types

Unlike single-purpose equipment, the Aenitis platform adapts to evolving needs:

- Phase-Appropriate Deployment: Scale seamlessly from preclinical to commercial

- Rapid Customization: Custom single-use consumables delivered in 4 months

- Future-Ready: Compatible with emerging applications like vesicle production and enhanced viral transduction

Our proprietary platform combines scientific rigor with practical manufacturing requirements:

- Higher flow rates than competing microfluidic systems

- Superior modularity compared to fixed chamber designs

- Proven performance with diverse cell types from platelets to stem cells

- Direct integration capability with existing production infrastructure

- Detailed technical specifications and performance data

- Case studies across multiple cell types and applications

- Complete theoretical framework for assessing compatibility with your processes

- Roadmap for implementation in GMP environments