N-1 Perfusion
With increasing development cost (>30%) and reduction in sales (<50%) biomanufacturers need to increase productivity of their facility to reduce overall COGS to stay competitive. Intensifying their seed train, especially the N-1 step, is one of the most adapted and logical change that the manufacturers can implement.
In this webinar, Sartorius experts present the latest PI technologies, including advanced Biostat® bioreactors integrated with PAT functionality controlled by the Biobrain® automation platform.
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N-1 perfusion can lead to 2x higher titer, reduce the overall USP duration and increase throughput by 20–50%.
Thanks to increased throughput, the impact of additional media requirements on cost or facility setup is mitigated.
N-1 leads to an easy retrofit in existing Fed-Batch facilities without changing the Fed-Batch strategy in the main bioreactor.
With higher throughput and increased productivity, N-1 perfusion reduces cost per gram by 30–50% compared to traditional Fed-Batch.
Options for stirred tank and rocking motion bioreactors
For the larger volumes needed to increase cell density
Ensuring quality, safety, and efficacy at all times
In the N-1 perfusion high inoculum fed-batch process, the production bioreactor is seeded at a higher density, accelerating cell growth. Biomanufacturers can leverage this benefit in two ways:
Sartorius is the only company offering N-1 seed train intensification options for both rocking motion and stirred tank bioreactors.
Implementing rocking motion bioreactor, with integrated perfusion membrane, in the N-1 seed train step is the most cost-effective opportunity for seed train intensification for high inoculum fed-batch process. Using the RM bioreactor manufacturers can
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Sartorius Biostat STR® bioreactors are available with integrated XCell ATF® technology, enabling an easy switch form batch to perfusion processes in any stage of the seed train. Implementing intensification or perfusion in the seed train achieves a higher N-1 cell density that, in turn, enables a higher inoculation cell density of the N bioreactor. This provides considerable benefits:
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Running the N-1 seed train step in perfusion mode requires a larger amount of cell culture medium than in standard fed-batch. Ensuring consistent cell culture performance in intensified processes is dependent on the media design, quality, and stability. Consumables and equipment to handle these volumes are equally essential to support a smooth process flow. A reliable filter to avoid contamination and remove mycoplasma is also critical for successful intensified processes.
Explore the implications of media management in an intensification strategy in this webinar featuring Sartorius experts.
Flexsafe® Pro Mixer is an efficient, single-use mixer for 50 L up to 3000 L. It provides the high levels of control that are essential for cGMP biomanufacturing.
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N-1 perfusion requires more cell culture medium, so consumables and equipment to handle these volumes are essential for a smooth process flow. Sartorius Flexsafe® 2D Single-Use Bags ensure the stability and integrity of the medium, allowing excellent, reproducible cell growth. The superior strength of the PE film reduces risk of damage, while its flexibility enables consistent performance and easy handling.
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Liquid medium must be prepared and safely stored to be ready whenever it is needed. To meet the significant cell culture media requirements of N-1 perfusion and support smooth process flow, larger scale liquid storage is often required. Flexsafe® 3D Single-Use Bags, designed for storage applications in pallet tanks, are easy to use and allow excellent and reproducible cell growth. With a self-deploying accessory, the bag can be filled with no operator manipulation. These ready-to-use bags have “plug and play” compatibility with Sartorius Biostat STR® bioreactors
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Companies are looking more and more for virus removal filters for media for risk mitigation purposes. Virosart® Media filters, provide high virus clearance safety and show superior capacities for media used for mAbs and recombinant proteins.
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Sartopore® 2 XLM sterile filters are used for cost-efficient media filtration with outstanding high throughput. They feature a 30% larger surface area and optimized pre-filter layers which results in a higher flow rate and higher throughput. The Sartopore® 2 XLM is an advanced 0.1 µm rated filter with high mycoplasma retention.
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This webinar presents how Intas Pharmaceutical, a leading biosimilars product manufacturer, targeted seed train intensification as a viable entry point to explore intensified manufacturing.
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Key Note Presentation at BPI Amsterdam - Miriam Monge, Head of Marketing Single-Use Technologies at Sartorius, was giving an overview of upstream and downstream Process Intensification, including cost & facility footprint implications of various process intensification scenarios.She discussed how the selection of given process strategies directly impacts environmental sustainability in biomanufacturing in terms of CO2, water and electricity usage and showed how single-use technologies can further drive environmental sustainability in biomanufacturing.Download eBook
Change can be risky, but also beneficial. Watch this video to learn about the benefits of using PI to overcome common challenges in biomanufacturing. Sartorius experts describe how PI components can help organizations implement changes gradually that will contribute to lower COGS, a smaller facility footprint, higher productivity, and faster time to market.
Process intensification (PI) enables faster drug development and increased productivity, flexibility, and quality. But with these benefits, PI can also introduce the challenge of increased media volumes and how to manage them in upstream processes. This whitepaper helps ensure your implementation strategy accounts for the increased media volume associated with process intensification.
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Customers rely on enhanced approaches to data analytics for process intensification. This is due to the increased complexity of processes, operations, and data, as well as the total cost of risk. Multivariate Data Analysis (MVDA) extracts meaningful information from large data sets. It enables scale-up and batch-to-batch comparison investigations to improve the quality, safety, and efficacy of a drug product.
SIMCA® is an advanced data analytics solution to gain actionable information from large quantities of data, ensuring consistent processes and product quality. SIMCA® analyzes incoming raw materials and determines how they may affect cell growth, viability, productivity, and quality – which is critical for N-1 perfusion. This robust multivariate engine will compare batch-to-batch quality and identify sources of any variation, accessible through an intuitive interface and easy-to-read interactive visualizations.
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Multivariate real-time monitoring is important, especially in intensified processes. While SIMCA® creates a digital fingerprint of a process as reference, SIMCA®-online uses real-time measurements to assess operations based on this fingerprint – essentially verifying if the current batch fingerprint matches or not. If there are derivations from the reference, the process can be adapted immediately. This automated corrective action keeps quality consistent, maximizes efficiency and reduces costs.
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Sartorius' experts sharing best practices and addressing critical questions.
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