How Do You Balance Today’s Demands With Tomorrow’s Discoveries?
Modify. Intensify. Amplify.
As biopharmaceutical manufacturers and CDMOs face growing pressure to increase throughput and lower costs in order to stay competitive, process intensification (PI) seems the natural solution – but many feel implementing that level of change is an unrealistic expectation. Sartorius helps manufacturers balance today’s demands with tomorrow’s discoveries, intensifying key processes to experience the benefits of PI now while building for the future.
Sartorius offers various intensified solutions that can be applied to both upstream and downstream unit operations that will result in increased overall productivity of your process or facility. Our technologies, which include high-throughput tools for process development and scalable, flexible manufacturing solutions, combined with our team of expert application scientists, help manufacturers succeed in their PI journey.
Process intensification is a holistic framework to maximize overall productivity of the unit operation(s), or the manufacturing process, or the facility output for biomanufacturing.
Why Intensify a Bioprocess?
Faster drug development
Achieve up to 4x increase in titers in upstream processing
Increase productivity in downstream by up to 50x
Reduce chromatography resin volume and costs by up to 80%
Applicable to any process irrespective of molecule
Get expert insights into the multifold benefits of process intensification for biologics manufacturing.
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For biopharmaceutical manufacturers to stay competitive while delivering multiple specialized products in smaller batches or blockbuster-level volumes, they must achieve the highest levels of productivity possible. Unfortunately, many are operating within existing stainless-steel facilities built for large volumes, and they cannot compete with facilities that employ single-use solutions and other intensified technologies.
Intensifying seed train operations is one way to see immediate impact on upstream productivity.
Concentrated fed-batch enables manufacturers to achieve productivity levels up to four times that of standard fed-batch operations. Enabling concentrated fed-batch capabilities is one way Sartorius helps bring process intensification technologies into existing systems or when planning new facilities.
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The biopharma industry wants the capability to increase biomanufacturing productivity on demand. See why process intensification is the best way to achieve this goal.
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In the past 10 years, the average annual peak sales per molecule has decreased by 50% while average annual costs to develop each molecule increased by 30% – this introduces a mission-critical need to reduce COGS. Manufacturers that currently rely on fed-batch operations have an opportunity to introduce technologies that can quickly modify their existing upstream processes to bring larger gains in productivity and ultimately reduce production costs.
Implementing N-1 perfusion in the seed train can result in a 30-50% reduction in cost/g compared to standard fed-batch operations and is a key example of process intensification. Sartorius is the only company offering two flexible N-1 seed train intensification options for rocking motion and stirred tank bioreactors along with state-of-the-art integrated analytical tools:
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As medicines become more specialized, the number of low-volume batches and variables in manufacturing processes will increase significantly. Analyses of commercial R&D pipelines between now and 2025 indicate more than 80% of candidates would require production of less than 500 kg per year to meet demand. To keep up with these trends, manufacturing operations need to manage higher throughput of individual therapies as well as accommodate different modalities within the same facility.
Sartorius can help introduce concentrated fed-batch (CFB) technology, enabling manufacturers to achieve throughput 3-4 times higher than standard fed-batch. This supports intensified bioprocessing and the flexibility biomanufacturers require to remain competitive:
Traditional upstream operations that rely on fed-batch processes simply cannot support the diversity of modalities resulting from innovations in protein-based medicines. Meanwhile, specialized medicines mean smaller throughput requirements, with almost 60% of drugs requiring 300 kg/year throughput or less to satisfy patient demands. Given these trends, manufactures are looking for flexible smaller modular Single Use perfusion based facilities to support this diversity in modalities and enable faster changeovers between multiple products.
Manufacturing multiple modalities relies on introducing perfusion-based technologies that require smaller bioreactors which often results in modular facility designs. This results in a smaller footprint, lower upfront capex investment and reduced changeover times due to single-use technology implementation.
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Reducing your bioprocess footprint can help you maximize efficiency and conserve valuable resources. Find out how to save space at your site with process intensification.
Speed-to-market is often what determines a product’s competitive position and pricing. Selecting the right process development tools that can reduce your development timelines and establish scalable flexible processes becomes very critical.
Sartorius offers several solutions to accelerate IND submission by reducing time spent on process development while integrating PAT for faster process optimization. Easy scale-up to any of the different upstream intensification schemes makes this approach very flexible.
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Biopharmaceutical organizations are always up against time pressures, and their biomanufacturing is often a major limiting factor, learn how process intensification can help.
Managing the media and buffer requirements for an intensified process is a crucial and demanding step that may pose further filtration challenges due to increased volumes and storage times. Optimal delivery of media and buffers is required to manage these volumes and processing.
To overcome media and buffer related challenges, you will need optimized and automated single-use solutions, that can prepare, mix, and store them for various intensified processes. In addition, high-throughput filters are required for optimal sterile filtration and risk mitigation. Thus, you will need:
To help you manage your media and buffer preparation, Sartorius´ portfolio of bioprocessing applications includes the following solutions:
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With increased demands, cost pressures and a multitude of products, facilities must be flexible, agile, and highly productive. Process intensification can help meet these demands, but implementation can be challenging. An effective solution is to intensify either the seed train or the production bioreactor with easily implemented and cost-effective solutions that enhance flexibility and productivity. For increased process understanding, in-line Process Analytical Technology (PAT) solutions are necessary, along with optimum clarification schemes, especially for high cell density perfusion processes.
To realize process intensification, you will need single-use, cost-effective solutions. Thus, for an intensified seed train or production bioreactor you will need:
If you are considering a shift from fed-batch to intensified process, Sartorius offers the following flexible perfusion-enabled solutions for both seed train and production
We offer the following single-use clarification solutions for high cell density cultures to remove cell debris and other product-related impurities:
Capture chromatography is usually the first purification step and requires optimal reduction of both product- and process-related impurities while maintaining high yields. Chromatography media can be very expensive, and its capacity can be reduced in a single column operation. Packing large columns leads to very labor- and time-intensive procedures that need additional space for processing and storage. It is desirable to have a semi-continuous mode of operation that is rarely satisfied by a single-column system with upstream perfusion processes.
For integration with high-titer, intensified upstream processes, you will need semi-continuous capture capabilities and technologies to:
To increase your productivity over batch chromatography and to reduce spending on chromatography resin, Sartorius offers the following flexible and scalable single-use solution for affinity chromatography:
Varying feed streams, concentrations and impurity profiles lengthen development and the optimization cycle of polishing chromatography steps. One needs to adjust the downstream suite rapidly to cater to changes in molecules coming in the pipeline. All these factors lead to low yields, ineffective impurity removal and thus a sub-optimal downstream process.
To intensify your polishing step effectively, you will need scalable chromatography solutions that enable efficient impurity removal and support flexibility, automation, and low footprint. You will need:
To help you achieve efficient impurity removal and increased yield while reducing footprint and buffer consumption, Sartorius provides the following single-use chromatography systems, along with high-capacity chromatography media and|or plug-and-play membrane adsorbers :
Viral clearance, including viral inactivation and removal, is crucial for patient safety. Inefficient virus inactivation due to lack of adequate hold times or pH control remains a challenge. Moreover, inefficient removal of different virus types, virus breakthrough due to pressure drops, low capacity and low flux filters result in increased filtration times and costs due to larger filter area required.
Your virus clearance approach requires reliable, scalable, and cost-efficient strategies that also deliver high product yields. You will need:
To support you in achieving robust virus inactivation, bioburden reduction and virus removal from various feed streams, Sartorius supplies the following scalable, high-capacity filters and single-use, modular automation platforms:
Tangential flow filtration (TFF) and sterile filtration are the last downstream steps to obtain the desired product concentration, buffer formulation, and final filtration of the drug substance. Low filter flux and capacity resulting from a very concentrated, potentially viscous feed stream lead to large filtration times and filter areas, thereby increasing overall costs. Furthermore, variation in feed streams and concentration leads to low throughputs over final filtration, resulting in a low yield of the drug substance.
To achieve formulated, sterile filtered bulk drug substance, you will need a high-capacity, high-throughput and fully scalable hardware system and consumable solutions for final formulation and filtration that include:
To boost your final product concentration, buffer formulation and sterile filtration, Sartorius offers the following high-flux, high-capacity, flexible and single-use TFF and final filtration solutions:
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.
Join Sartorius as we explore solutions for downstream process intensification. Our experts will discuss key technologies such as chromatography.
Explore the implications of media management in an intensification strategy in this webinar featuring Sartorius experts.
Sartorius' experts sharing best practices and addressing critical questions.
Miriam Monge talks about the significance of intensified and continuous processing, the importance of the arrival of biosimilars on the market, and exciting Sartorius developments in the commercial biomanufacturing industry.
The industry is redefining regulatory and industry standards due to the implementation of single-use technologies. How does this affect the benefits of process intensification? Watch Miriam Monge in discussion with Dan Stanton, Editor of Bioprocess Insider.
How do single-use facilities influence cost of goods, flexibility, and reduced footprint in biopharmaceutical manufacturing and how does process intensification play a role? Watch Gerben Zijlstra in discussion with Dan Stanton, Editor of Bioprocess Insider.
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