Intensified & Continuous Upstream (USP) Processing
Future-proof your manufacturing strategies, reduce costs and increase facility flexibility with intensified fed-batch and perfusion processes
Biopharmaceutical developers and manufacturers need efficient, productive upstream processes that deliver high quality monoclonal antibodies (mAbs) and other types of recombinant proteins. Process intensification, including intensified fed-batch and perfusion processes, can future-proof their manufacturing strategies, reduce costs, and increase facility flexibility.
With a full suite of solutions designed to support the increased demands of intensified upstream processes and technical support from teams with years of experience, we can help you realize the benefits of upstream process intensification without compromising clinical milestones or speed to market.
Production and Harvest Intensification
A holistic approach to optimize productivity, process efficiency, and product quality is essential for upstream process intensification. The BioContinuum™ Production and Harvest Platform enables manufacturers to successfully develop and scale up their perfusion processes. It includes:
- CHOZN® GS cell line platform, including cell lines, expression vectors, and protocols for cell line development;
- EX-CELL® Advanced HD Perfusion cell culture medium, designed for high productivity and viable cell densities;
- Mobius® Breez Microbioreactor, designed for efficient perfusion optimization;
- Mobius® 3 L Bioreactors, paired with the Cellicon® Cell Retention Solution for benchtop scales;
- Mobius® iFlex Bioreactor, a family of modular bioreactors designed for high-cell density processes with both batch and perfusion configurations;
- Cellicon® Cell Retention Solution, a standalone cell retention system and filters for perfusion applications;
- Application studies demonstrating process scalability and performance;
- Comprehensive technical guidance and services from our experienced technical support teams.
Perfusion Process Development
Continuous upstream processes require optimization of cell productivity, perfusion rates, cell bleed strategies, and cell retention methods to maximize efficiency, yield, and quality. The operational complexity of perfusion-based processes can be managed easily with technologies supporting efficient exploration of the process design space and in-depth technical advice from experienced experts. The BioContinuum™ Production and Harvest Platform simplifies perfusion process development and enables manufacturers to develop their mAb processes with confidence. With high-performing cell culture reagents and bioreactors designed for perfusion processing, process developers can ensure they have a strong foundation for their next-generation upstream processes. Process recommendations, application studies, and technical guidance enable a seamless transition into larger scales.
Perfusion Manufacturing
As biopharmaceutical manufacturers transition from small-scale to commercial production, bioreactor and cell retention filter design play a central role in the upstream process. While a robust process developed at smaller scales is a critical first step, biopharmaceutical manufacturers also need to trust that their process performance remains robust and can be implemented at larger scales. Well-characterized systems and cell retention devices, as well as implementation of engineering best practices in system design, reduce uncertainty in scale-up. With purpose-built bioreactors and cell retention systems designed for scalability, the BioContinuum™ Production and Harvest Platform helps manufacturers scale up their perfusion processes confidently into clinical and commercial manufacturing.
Related Categories
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Related Resources
- Article: Accelerate Perfusion Media Development and Predict Large-Scale Processes using a Single-use, Automated Microbioreactor
- Article: Scalability and Performance of Mobius® iFlex Bioreactors
- Flyer: Mobius® Breez Microbioreactor
A 2 mL Automated Perfusion Cell Culture Platform: Do more with less and accelerate your path to process intensification.
- Application Note: Scalability from Mobius® 3 L Single-Use Bioreactor to 50 L – 2000 L Mobius® iFlex Bioreactors to Support Intensified Upstream Process Development
Properly scaling from Mobius® 3 L Single-Use Bioreactors to Mobius® iFlex Bioreactors for intensified processes is highly dependent on maintaining mixing, oxygenation, nutrient, and process control.
- Mobius® iFlex Bioreactors for Fed-Batch and Perfusion Upstream Processes
The Mobius® iFlex Bioreactor family includes pilot, clinical and commercial manufacturing (50 – 2,000 L) single-use bioreactors that enable mammalian cell culturing capabilities from early process development through commercial batch production.
- Mobius® Breez Microbioreactor for Perfusion Process Development
The Mobius® Breez Microbioreactor is a 2 mL automated single-use perfusion system designed to support gentle, adaptable, and reproducible cell processes.
Related Services
- System Service Reliance Plans
Our system service reliance plans and maintenance services provide critical upkeep and repair of your bioprocessing systems, helping you to minimize risk, prevent downtime, and maintain optimum performance.
- Custom GMP Cell Culture Products
Our custom cell culture product design experts can offer advice and support as you scale your bioprocess from clinical to commercial supply, assisting with liquid products, dry powder products, selection of raw materials, quality testing, flexible product packaging, and product documentation.
BioContinuum™ Platform: Your enabler of the biomanufacturing facility of the future!
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