Gene Therapies

Increase product purity, boost yield, and cut production costs with the UniFuge® platform. Optimize lentiviral and AAV vector production with low-shear technology for cell separation and overcome titer loss, filter clogging, and contamination in shear-sensitive applications.

How It Works

One cell processing platform for gene therapy development and manufacturing

Protect sensitive materials and avoid unnecessary filtration steps with UniFuge’s tubular bowl technology. UniFuge offers a low-shear solution for both AAV and lentiviral processing, preventing vector damage and reducing impurities such as HCP contamination in the final gene therapy product.

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Cell Banking

The closed system harvests and concentrates cells such as HEK, performing media exchange to reduce contamination risk during cryopreservation.

Gene Editing

Gentle separation concentrates cells and exchanges media with buffers, preserving cell integrity and enabling vector production.

Seed Train

Scalable processing efficiently separates and concentrates cells, preparing them for transfer to larger bioreactors for further expansion.

Intensification

Media exchange and optional washing maintain cell health for n-1 intensification, enabling advanced manufacturing strategies.

Clarification

Low-shear separation and concentration, with optional washing, preserves viral vector integrity and maximizes recovery, ensuring higher yields.

Downstream Processing

Gentle clarification ensures fewer impurities when harvesting whole cells, enabling cleaner viral vector preparations, reduced purification burden, and a higher-purity final product.

Key Benefits

Benefits of using CARR Biosystems for Gene Therapies

Sustainable Production

No flushing cycles, reducing water usage compared to filtration
Minimized waste from single-use technology

Increased Product Recovery

Tunable parameters for maximal product recovery
Reduced filtration-induced titer loss during centrifugation

Improved Bioprocess Efficiency

Reduced impurities from cell or vector damage due to low-shear
Improved efficiency with simpler downstream processing

Seamless Scalability

Seamless scalability from development to manufacturing
Automated processes with quick setup in under 15 minutes
21 CFR Part 11 Compliant

Data Highlights

Improved titer yield and reduced need for filtration due to low-shear

Overall Titer Yield

UniFuge overcomes titer loss by minimizing physical damage to viral vectors and cells during clarification and separation steps, increasing vector yield from 37% to 54%, and improving overall yields in gene therapy production.

Feed Pressure and Filter Loading

UniFuge demonstrates a reduced need for secondary filtration, with secondary filter loading comparable to primary depth filtration up to 140 L/m2 but with a stable pressure drop when processing tubular bowl broth.

Case Study

Single-use systems boost viral titer from HEK293 cell culture

The Challenge

Today’s bioreactors can produce high-density HEK293 cell cultures at volumes of 2000L or more. Traditional depth filtration methods cannot keep pace, resulting in a workflow that is labor and resource-intensive, low titer, and inefficient.

The Solution

CARR Biosystems partnered with a customer to clarify HEK293 cells containing viral vectors with the UniFuge Mini. Various g-forces (2000–4000xg) and feed flow rates (200–600ml per minute) were tested to find the optimal conditions.

The Outcome

The UniFuge Mini resulted in:

Higher throughput: increased from 46L/m² to 59L/m².
Reduced filter usage: requiring 28% less filter surface area for clarification.
Increased viral titer: A 46% boost was observed after secondary filtration.

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Endorsements

See what people are saying about Gene Therapies

“The UniFuge has higher g forces and flow rates [compared to competitive offerings].”

Viral Vector Bioproduction Expert, HEK

“My biggest reason to avoid centrifuges has been that they don’t scale down, so process development is hard, and clean-in-place is a pain. [UniFuge] neatly addresses both.”

Viral Vector Gene Therapy Bioproduction Expert

Application Resources

Clarification of CHO Cells with the UFMini

Discover how single-use centrifuges streamline cell clarification with low-shear separation that results in high yield and cell viability.

Whitepaper

Addressing the Complexities and Challenges in Lentivirus Harvest Clarification

Read how single-use centrifugation improves recovery, reduces the need for filtration, and boosts operational efficiency in gene therapy production.

Article

Single-Use Centrifuges Are Transforming Biopharmaceutical Development and Manufacturing

Learn how UniFuge can boost productivity, reduce costs, and provide a scalable solution from bench to manufacturing.

Whitepaper

See More Publications

Centrifuges

Scale up or down with UniFuge

Frequently Asked Questions (FAQs) About Gene Therapies

How does the UniFuge platform improve lentiviral production for gene therapies?

The UniFuge platform uses low-shear tubular bowl centrifugation, which minimizes particle loss, reduces HCP contamination, and eliminates filter clogging. This results in higher product purity, improved yield, and reduced downstream processing requirements. The UniFuge is also appropriate for AAV and other vector types.

How quickly can I set up and operate the UniFuge for my gene therapy application?

The UniFuge features a user-friendly design with an easy setup process that takes less than 15 minutes. Its automation capabilities reduce manual intervention and speed up production, saving time and labor.

How does the UniFuge help with scalability in gene therapy manufacturing?

The UniFuge platform is fully scalable, owing to the family of products that include the Mini, Pilot, and U2k. This seamless scalability allows users to transition from bench-scale processes to large-scale production while maintaining consistency in performance, reducing process variability, and ensuring regulatory compliance.