Applications | Design & Manufacturing | Cell & Gene Therapy
Streamline cell & gene therapy manufacturing from concept to cure
Whether you’re treating degenerative conditions, autoimmune disorders, or cancer by targeting disease at the cellular level, or developing living therapeutics to restore or enhance tissue function to advance more complex disease research, Ascential is ready to support your processes. Our team’s bandwidth and expertise help you scale your cell and gene therapy (CGT) manufacturing throughput with expertise such as:
- Automated Manufacturing Platforms (CAR-T, TCR-T, NK Cell Workflows)
- Non-Viral Transfection and Cell Engineering Instruments
- Closed-System Cell Processing and Handling Instrumentation
- Viral Vector Production Support Platforms
- Cell Washing, Concentration, and Formulation Systems
- Cryogenic Handling Hardware Systems
- Single-Use Fluidic Assemblies and Sterile Consumables
- Cell Therapy Workflow Automation and GMP-Ready Equipment
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Solutions
Design advanced cell & gene therapy workflows for regulatory readiness
Cell Therapy Platform Development
Enhance GMP-readiness with full instrument design from concept through production. We can engineer closed-system fluidic architecture; low-shear pumping and flow control; aseptic connector integration, automation, and controls; environmental enclosure design; and instrument control software.
Fluidic Assembly & Consumable Development
Build sterile tubing manifolds and disposable flow paths for volume manufacturing processes and integrate fluidic kits engineered for biocompatibility, leak integrity, sterilization compatibility, and high cell recovery.
Aseptic System Architecture & Contamination-Controlled Design
Reduce cross-contamination for platforms operating in GMP environments with sealed fluidic paths, aerosol containment, and cleanroom- compatible mechanical design.
Prototype & Alpha Platform Builds
Validate cell handling performance and de-risk architecture decisions with early process development support. Our experts deliver rapid functional prototypes and alpha-stage systems.
Sustaining Engineering & Cost Optimization
Yield improvement, resolve component obsolescence, and strengthen program reliability for fielded cell therapy platforms.
Capabilities
Manufacturing for biological performance & seamless scale-up
Closed-System & Aseptic Fluidic Architecture
Maintain batch integrity by designing cross-contamination mitigation into the system architecture. Ascential routinely works on sealed fluidic paths with sterile connector integration, leak-proof flow path engineering, aerosol containment, and surface material selection validated for sterilization compatibility.
Consumable Design for Spatial Workflows
Preserve tissue integrity and minimize edge effects with designs engineered for uniform reagent distribution, clear optical windows, and consistent instrument interfaces. We ensure spatial data is artifact-free and reproducible across the full sample.
Low-Shear Cell Handling & Flow Control
Minimize cell loss and activation during processing steps with pump selection and flow path geometry designed to minimize shear stress on fragile cell populations. Our team’s intentional automation approach protects your biology from controlled flow rates, to bubble detection and elimination, to precision volume metering, to high-recovery fluid transfer paths.
GMP-Ready Design & Manufacturing
Ensure equipment holds up to regulatory scrutiny without a retrofit cycle. Our team handles design controls per ISO 13485; risk management per ISO 14971; requirements traceability; verification and validation execution; DFM for cleanroom production; electrical safety and EMC compliance; and design transfer to manufacturing environments with the contamination control and documentation requirements of cell therapy equipment production.
Case Study
Engineering scalable cell therapy platforms for clinical success
An integrated development and manufacturing organization (IDMO) needed to transition from a lab prototype to low-volume manufacturing and sought to implement rapid bill of materials (BOM) changes, as well as infrastructure and packaging design for the assembly of large, heavy subsystems. Ascential developed new assembly and testing procedures, resolved production issues, and redesigned key subsystems with minimal disruption. In just 5 months, our team loaded a 10,000-item BOM with 20 sub-assemblies, sourced components, and finalized the first product batch. Our process optimization enabled ocean delivery of the organization’s 12,000-lb instruments worldwide.
Now, the IDMO has a fully integrated, scalable, cGMP cell therapy manufacturing platform that was FDA certified as an Advanced Manufacturing Technology (AMT) and proved critical to clinical trial collaborations with pharmaceuticals.
Why Choose Ascential?
CGT Manufacturing Domain Expertise
We evaluate pumps against shear-induced cell damage thresholds and characterize any fluidic dead volumes against your cell recovery targets.
Integrated Engineering
Resolve material placement, design, and automation trade-offs in real time with our cross-collaborative team. We help you strengthen coordination between your fluidic architecture, automation sequencing, contamination control, and consumable interfaces.
GMP-Aware Manufacturing
Ensure designs fit manufacturing constraints from early development through execution. Ascential produces CGT manufacturing equipment at our ISO 13485-compliant sites, with cleanroom production capability, to centralize and streamline production efforts.
Complex Consumable & Production Automation
Improve and scale quality assurance with thoughtful automation integration, which can include cleanroom assembly, leak testing, sterile packaging, bonding, and in-line inspection. We design, build, and support automated production lines for high-precision life sciences consumables.
Frequently Asked Questions
Get answers to common questions about our cell and gene therapy capabilities.
Yes. Ascential engineers disposable flow paths, tubing manifolds, sterile connector interfaces, and integrated fluidic kits designed for biocompatibility, leak integrity, sterilization compatibility, and volume manufacturing.
Spatial platforms require tighter subsystem coordination than most instruments: the timing between fluidic delivery, thermal setpoints, stage moves, and image acquisition all interact. Ascential experts have direct experience managing these interactions at the systems engineering level, with all subsystem disciplines in-house.
Either. Ascential routinely integrates client-preferred suppliers for biocompatible tubing, sterile connectors, pumps, and valves. Where you don’t have a preference, we use our qualified supply base. For components critical to cell contact and sterility, we recommend qualifying alternatives early.
Related Resources
Accelerate your CGT commercialization to improve patient access
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