Clarifies and Harvests Cells from Cultures

The GEA kytero® single-use Separator, engineered by GEA, offers a streamlined solution for cell harvesting in the pharmaceutical and biotech sectors. This disk stack separator excels in clarifying mammalian and E. coli cultures without the need for complex cleaning cycles, thanks to its single-use design. This setup not only reduces batch preparation time but also eliminates the dependency on filtration systems by cutting the required filter area significantly. The separator is perfect for producing monoclonal antibodies, vaccine components, and protein therapeutics with high separation efficiency. It integrates seamlessly into any pharma cleanroom environment and fits within plug-and-produce operations. With no need for SIP/CIP processes, it allows rapid batch turnover, enhancing throughput and operational flexibility. Engineered with a contact-free drive system, it ensures low maintenance and high reliability, designed to meet GMP standards and streamline your production line operations.

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Mixes and Resuspends Biopharmaceutical Liquids

The Truelev Low Shear Magnetic Mixer from Metenova is engineered to address critical mixing needs in the biopharmaceutical, biotech, and chemical industries. Utilizing magnetic levitation technology, it ensures non-contact mixing, preventing contamination and enhancing product integrity. This mixer excels in applications such as vaccine solutions, monoclonal antibodies, and biologic drug formulations, providing efficient resuspension and emulsification. Designed for both batch and continuous operations, it integrates seamlessly into your production line with manual or automated controls. Constructed with corrosion-resistant materials, the Truelev Mixer meets rigorous GMP and FDA standards, making it ideal for cleanrooms and sterile environments. Its energy-efficient motor reduces operational costs, and optional CIP/SIP systems allow for swift and thorough cleaning between batches. Customization is available for specific processing requirements, supported by Metenova’s engineering expertise.

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Handles and Sterilizes Liquid Media and Buffers

This Bioprocessing Liquid Cell Culture Media and Buffer System supports pharmaceutical and biopharmaceutical manufacturers in enhancing production efficiency. It ensures precise handling and sterilization of liquid media, transforming complex processes like mAbs and mRNA development. Capable of integrating seamlessly into existing production lines, it employs sterile filtered systems to minimize contamination risks—ideal for fast-paced environments from bench to full-scale operations.

Processing capacity ranges from small to large-scale batches, accommodating diverse operational needs. Leveraging advanced single-use assembly systems, it reduces setup time and operational complexity. The system is compliant with ISO 9001:2015 and GMP standards, ensuring adherence to stringent regulatory requirements.

Energy efficiency is a core design feature, with a focus on sustainable operations through reduced water for injection usage and streamlined buffer preparation. It’s equipped with customizable options, including various material finishes to meet specific chemical compatibility needs. Maintenance is simplified by an integrated cleaning-in-place (CIP) system, which promotes rapid, contamination-free transitions between production cycles. This system stands out for its automation capabilities, with PLC control and remote monitoring to optimize workflow and ensure reliability in diverse bioprocessing applications.

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Ensures Viral Clearance in Bioprocessing

The Viresolve®Pro Solution from a leading manufacturer in virus filtration offers a robust system for achieving effective viral clearance in biopharmaceutical processes. Featuring a range of modular pod filter holders and single-use filtration systems, it efficiently handles filtration and viral clearance in applications such as monoclonal antibodies and mRNA vaccines. The system’s unique design ensures scalability from pilot to large-scale processes, maintaining flexibility with manual and process-scale options.

The Viresolve®Pro’s workflow operates with pod and Magnus holders, facilitating easy assembly and operational modularity. It efficiently integrates into both existing and new production lines, optimizing throughput while maintaining product integrity, making it ideal for high-stakes environments like pharmaceutical manufacturing.

Engineered for minimal downtime, the system supports rapid changeovers with its quick-load mechanism, reducing lead times. Utilizing durable materials, it withstands the rigors of repeated use, ensuring long-term performance and compliance with stringent industry standards.

Additionally, the Viresolve®Pro addresses energy efficiency, reducing operational costs through optimized motor control, while its CIP-ready (Clean In Place) design allows for straightforward maintenance, promoting seamless operations in varied bioprocessing scenarios.

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Sterile Aseptic Filling and Fluid Path Management

The AccuFill™ Aseptic Filling System from Meissner Corporation specializes in revolutionizing biopharmaceutical and pharmaceutical manufacturing with its single-use design that eliminates cross contamination and reduces cleaning requirements. This system is ideal for aseptic filling of vaccines, monoclonal antibodies, and parenteral drugs, using proprietary disposable fill liners that seamlessly integrate into sterile filling processes. Designed for capacities ranging from 100 L to 20,000 L, it supports swift batch changeovers to minimize downtime. Featuring robust automation, it offers efficient fluid path management, enhancing the throughput of single-use assemblies. Built to comply with stringent biopharmaceutical standards, it ensures reliable and sterile production environments without extensive manual intervention. The system is customizable for unique operational needs and supports easy scalability of biopharmaceutical operations.

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Facilitates Scalable Single-Use Bioprocessing

The SUPR from Getinge Applikon is a single-use production reactor designed for bioprocessing applications in the biopharmaceutical industry. Leveraging the Click-n-Go system for rapid setup, it simplifies cultivation and sampling, ideal for monoclonal antibody production, CAR-T cell therapies, and mRNA vaccines. It supports seamless scaling from R&D to production, utilizing 50 to 250-liter containers, with a 1000-liter option forthcoming. Constructed from USP Class VI certified materials, it eliminates cross-contamination and minimizes cleaning requirements through gamma irradiation. The SUPR integrates easily with existing systems, offering compatibility with DeltaV™ DCS and Siemens PLCs. It complies with cGMP standards, ensuring quality and regulatory alignment for biotechnological applications.

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Cultivates and Scales-Up Cell Cultures

The Applikon AppliFlex ST from Getinge offers a versatile single-use stirred tank bioreactor designed for biopharmaceutical applications. This bioreactor stands out with its fully customizable design, incorporating 3D printing technology for tailored head plate configurations. It excels in cell line development and process scale-up for producing monoclonal antibodies, CAR-T cell therapies, and other biologics. Capable of cultivation, mixing, and fermentation processes, it offers working volumes of 500 mL to 15 L. With the use of single-use technology, it ensures sterility and minimizes contamination risk, effectively supporting batch, fed-batch, and perfusion operations. The bioreactor is constructed for easy integration into lab environments and complies with industry standards, promoting efficient, reproducible results in research and development settings.

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Regulates and Seals Hygienic Processing Lines

The Unique SSV DN125 and DN150 from Alfa Laval stand out as robust pneumatic single seat valves designed for hygienic applications in the dairy, food, beverage, and pharmaceutical industries. These valves are engineered with a modular structure, offering the flexibility to customize valve bodies, plugs, and actuators for specific process requirements. The single seat design minimizes contamination risk, optimizing safety in your production line. Utilizing air-operated mechanisms, they effectively regulate processes involving high-viscosity fluids and large particles. Built from durable, stainless steel material and compliant with 3-A and hygienic standards, they ensure high reliability and longevity. Integration with existing systems is seamless, and options such as fully maintainable actuators and various wetted seal materials enhance their functionality. The Unique SSV range also includes advanced features like enhanced performance actuators for safer operations, reducing wear with metal-to-metal contact, and low total cost of ownership owing to minimal maintenance needs.

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Expands and Amplifies Cell Cultures

The CES Cell Expansion System from Tofflon Life Science is engineered for scalable cell culture and seed amplification, pivotal in the production of biopharmaceuticals and vaccines. Utilizing rocking technology, this system ensures optimal mixing and ventilation, crucial for cell growth and expansion. It’s particularly effective in producing monoclonal antibodies, CAR T-cell therapy products, and stem cell-based treatments. The system’s single-use design minimizes contamination risks, ensuring a sterile environment, while supporting seamless integration into existing production lines. Capable of handling various cell types, it meets GMP standards, making it an ideal choice for pharmaceutical and biotech industries aiming for precision and reliability.

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Mixes and Sterilizes Biopharmaceutical Process Fluids

The Thermo Scientific™ HyPerforma™ Single-Use Mixer DS 300 is engineered for the stringent demands of biopharmaceutical processes. Its stainless steel construction ensures robust and sterile operations, making it ideal for the preparation of monoclonal antibodies, vaccine formulations, and cell culture supplements. This mixer operates with precision through a variable speed range of 30-350 RPM, facilitating diverse tasks from hydration to sterile mixing in batch or high-throughput settings.

Equipped with a docking station featuring a vertical lift and motor mount, the HyPerforma DS 300 integrates seamlessly into existing production lines. The unit accommodates up to 300 liters, with options for both top and bottom-drain configurations, tailored to your specific processing needs. Its closed-system design significantly minimizes cross-contamination, aligning with GMP standards for pharmaceutical-grade applications.

Energy-efficient with a 15-amp power requirement, the mixer supports operational savings while maintaining high performance. Optional components like adjustable-angle motor heads and reusable bearing hubs provide further customization for enhanced process adaptation. Simplify your maintenance with integrated control systems designed for ease of use and effectiveness in bioprocessing environments.

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