Process Development to Commercial
Eliminate tech transfer risk. Scale your iPSC or viral vector process with a single centrifuge platform that maintains consistent performance from 500 mL to 2,000 L.
The challenge
Moving from discovery to GMP often means changing centrifuge technology entirely — triggering months of revalidation.
Larger centrifuges often increase shear forces, damaging sensitive iPSC aggregates and reducing viral vector titers.
Different separation principles at different scales produce variable concentration factors, making process control unpredictable.
Variable washing and buffer exchange efficiency across scales makes it hard to lock in formulation parameters during PD.
Linear scalability
| Parameter | UFMicro | UFMini | UniFuge Pilot | U2K |
|---|---|---|---|---|
| Scale | Research | PD | Pilot / Phase I | Commercial |
| Volume range | <500 mL | 0.5–50 L | 50–200 L | 200–2,000 L |
| Separation principle | Tubular bowl — identical across all scales | |||
| Single-use modules | ||||
| Recipe transfer | Direct recipe transfer — no reoptimization required | |||
| 21 CFR Part 11 | — | |||
The tubular bowl design delivers the same g-force profile and separation efficiency at every scale — what works at 500 mL works at 2,000 L.
Lock in your g-force, flow rate, and wash parameters during PD. Transfer them directly to the next scale with no reoptimization.
CARR's application scientists provide hands-on support during PD, plus predictive calculators to model performance at target scale.
Performance data
UniFuge maintains iPSC pluripotency while performing high-efficiency media exchange — critical for feeder-free, xeno-free manufacturing processes.
Cell viability
Days pluripotency maintained
Media exchange efficiency
UniFuge optimizes lentiviral and AAV vector concentration, improving titer yields while reducing the need for downstream filtration steps.
Titer yield improvement
Less filter area required
Product recovery
Over 98% recovery and 99% viability across iPSC, TIL, stem, and NK cells using the UniFuge platform.
HEK293-produced lentiviral vectors showed 46% titer improvement and 28% reduction in required filter area compared to conventional methods.
Applications
Gentle separation preserves pluripotency during media exchange. Compatible with PBS Biotech vertical-wheel bioreactors for end-to-end workflows.
Low-shear concentration increases titer yield by up to 46% while reducing filtration load — a direct impact on COGS.
Efficient clarification of HEK293 lysate with high product recovery. Reduces turbidity and protects downstream chromatography steps.
Automated washing strategies remove process impurities while maintaining viability above 95% for patient-specific batches.
High-density CHO and HEK293 harvest with over 99% turbidity reduction. Sterile closed system maintains product integrity.
Gentle, scalable concentration of extracellular vesicles with preservation of size distribution and surface markers.
Case study
A gene therapy company needed to improve lentiviral vector yields during upstream concentration without damaging the fragile enveloped virus. Their existing TFF approach was causing significant titer loss and creating a bottleneck at scale.
CARR's PD team worked with the customer to optimize UniFuge parameters for their HEK293 suspension-based lentiviral production process. The low-shear tubular bowl design concentrated vectors without the membrane fouling issues seen with TFF.
"The UniFuge line is simpler and required less calibration than other solutions we have tried. The scale-up from UFMini to UniFuge Pilot was seamless."
Process Development Scientist — Gene Therapy
Centrifuges for PD teams
Start your PD work here. Lock in recipes that transfer directly to pilot and commercial scale.
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Scale to pilot and early clinical. Same recipes from PD, now GMP-ready with full documentation.
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Commercial manufacturing at over 2,000 L. The same separation principle and consumable design as your PD unit.
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Let's talk scale-up
Whether you're optimizing at bench scale or planning commercial manufacturing, our application scientists can help you map out a centrifugation strategy that grows with your program.
