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.
Seed Train Intensification
The traditional seed train process is time- and labor-intensive, requiring operators to transfer and manually cultivate the cells as they generate biomass to inoculate the production bioreactor. The manual transfer of cells between vessels also creates an increased risk of contamination.
Seed train intensification increases facility flexibility and reduces operator hands-on time, improving efficiency and reducing risk. This can be achieved in two ways, both of which are compatible with fed-batch and perfusion production processes:
- Perfusion operations in the seed train, which reach significantly higher cell densities than batch-based processes;
- Incorporation of high volume, high cell density cryopreservation sample bags to decouple manual inoculum train and bioreactor seed train processes, reducing steps, achieving time savings and enabling closed process operations.
The BioContinuum™ Seed Train Platform is the solution to intensify your seed train during mAb production.
The platform includes:
- Cellvento® 4CHO-X cell culture medium, designed for N-1 perfusion;
- Cellicon® Cell Retention Solution, a cell retention system designed for high cell density perfusion processes;
- Mobius® HCDC single-use assemblies for high volume, cell density cryopreservation;
- Comprehensive application studies and services from our technical support teams.
With these products, technical support, and application studies designed to address diverse manufacturing scenarios, mAb manufacturers can accelerate upstream process development and confidently scale up to clinical and commercial volumes.
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Related Resources
- Seed Train Intensification Using High Cell Density Cryopreservation
This article explains the benefits of high cell density cryopreservation (HCDC) and how to implement it.
- Impact of DMSO And Freezing Technique in Developing a High Cell Density Cryopreservation Process for Upstream Bioprocessing
Here, we evaluated how dimethyl sulfoxide and freezing techniques impact viable cell density and titer production in an HCDC intensified seed train.
- Optimizing CHO Cells for Higher Productivity
This application note describes the benefits and performance of Cellvento® 4CHO-X Expansion Medium designed for multiple cell expansion steps from vial thaw to N-1 stages to generate higher biomass for inoculating fed-batch production bioreactors.
- Cell Retention Technology and Specialized Cell Culture Media for Intensified Upstream Processing
This study demonstrates the use of a Cellicon® filter and controller in an N-1 perfusion process with Cellvento® 4CHO-X expansion medium as compared to a control seed train using shake flasks.
- Reproducible Scaling of a Cell Retention Filter Using the Cellicon® Cell Retention Solution
This page describes the design attributes of the Cellicon® Filter Assembly and how they simplify process scale-up.
- Operational and Financial Advantages of Cellicon® Cell Retention Solution in an N-1 Perfusion Process
The following study compares an N-1 perfusion process at the 2,000 L scale using our Cellicon® Cell Retention Solution versus a commercially available cell retention device.
Related Webinars
Explore the use and benefits of a high cell density cryopreservation (HCDC)
Intensified upstream bioprocesses are being developed to increase productivity while...
Learn how perfused seed train options could deliver lower cost of goods, increase product throughput, or a combination of both.
The integration of a perfused N-1 step in upstream process is highlighted to either decrease facility footprint or to be able to inoculate final fed-batch N-stage with a higher cell density as a conventional fed-batch.
Media composition plays a critical role for biopharmaceutical production as well as seed train expansion.
Upstream process intensification can bring significant benefits to manufacturers in terms of smaller facilities, manufacturing flexibility, and reduction in footprint, with achieving significantly higher productivity.
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BioContinuum™ Platform: Your enabler of the biomanufacturing facility of the future!
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