Dynamic Perfusion
Established manufacturers are looking to single-use, flexible solutions when building new facilities or modifying existing operations. Their goal is to increase productivity across different modalities including difficult-to-express molecules. Meanwhile, early-stage drug development companies are looking for low upfront investment for their lower throughput products. With smaller bioreactor requirements that deliver higher productivity per batch, dynamic perfusion can be the answer in both cases.
The up to 5x higher volumetric productivity in DP allows for a modular approach and smaller bioreactor sizes (<2000 L) for faster build-up times.
DP enables 2-5 g/L per day with continuous harvest of product over 2 weeks, achieving up to 5x higher productivity than Fed-Batch.
Continuous harvest ensures optimal product stability and quality, which is critical for unstable molecules prone to degradation.
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 dynamic perfusion, the product can be continuously harvested by microfiltration. This approach can be accomplished in smaller bioreactors, resulting in smaller footprint and as much as a 60% lower capex upfront investment. Productivity can be increased up to 5 times compared to standard fed-batch, while offering the flexibility to support multiple molecule pipelines, even for hard-to-express molecules.
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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Running a bioreactor in dynamic perfusion (DP) mode enables the use of smaller bioreactors, such as the Biostat STR® 500 L with integrated XCell ATF® technology, to run perfusion in microfiltration mode. Dynamic perfusion usually does not use cell bleeds, which results in increased viable cell density (VCD) as the product is harvested continuously for the next 15-20 days. This operation can lead to:
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Consistent cell culture performance in intensified processes is dependent on the media design, quality, and stability. In dynamic perfusion, fresh medium and feeds are added continuously over 15-20 production days, thus requiring smart media strategies. Consumables and equipment to handle these volumes are essential to support a smooth process flow, while reliable filters to avoid contamination and remove mycoplasma are 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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Sartorius Flexsafe® 2D Single-Use Bags ensure the stability and integrity of the medium, allowing excellent, reproducible cell growth. The superior strength of the polyethylene 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 – and in the case of dynamic perfusion, 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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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 data analytics for process intensification due to the complexity of operations, processes and data as well as the total cost of risk. Multivariate Data Analysis (MVDA) extracts meaningful information from large data sets, enabling 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 in dynamic 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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