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Expertise & Solutions

From Early-Stage Development to Commercial-Scale Manufacturing

Our purpose-designed state-of-the art cell separation solutions meet the specific needs of a variety of applications, from Cell Therapies to Cellular Agriculture.

Case Studies

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Cell Therapies

When producing Cell Therapies, cell viability and recovery are critical for product quality and economic feasibility. Additionally, maintaining sterility is a mandatory regulatory requirement since there is no option to perform terminal sterilization. The UniFuge® line is well suited for cell harvesting and washing, as it is both high-performance and simple to keep sterile. The UniFuge products are closed systems that enable sterility with single-use modules that have a SAL level of 10–6.

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Biologics

Biologics production requires the separation of cells and cell debris from the culture media. This step, called clarification, often relies on several stages of depth filtration, which is not scalable for large scale production. Our scalable single-use and stainless steel solutions offer the ability to fully eliminate stage one filtration while increasing product recovery. The high capacity and throughput of the U2k® makes it a great fit for the needs of CDMOs and Originator companies and the UniFuge® Pilot and UFMini® allow development and clinical manufacturing teams to develop and manufacture using smaller versions of the future commercial production equipment.

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Nucleic Acids

When producing plasmids, scalability and large volumes are crucial.

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Gene Therapies

Gene Therapies benefit from systems that minimize contamination risks to the product as well as to the environment, enable high product recovery and fast processing times. The UniFuge® addresses those needs. The UniFuge is ideal for delicate cultures, such as lentiviruses, and replaces filtration during primary recovery, eliminating the issue of filter clogging and HCP going to downstream purification.

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Vaccines

Vaccine products must meet stringent regulatory requirements. Amongst them, purity is sometimes the hardest to deliver. For products using Bovine Serum Albumin (BSA), the purification of this contaminant can require complex unit operations that are both costly and hard to scale up.

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Cellular Agriculture

Cellular Agriculture requires a fast but gentle cell harvest solution that is scalable from R&D, to Pilot, to production scale. In addition, the ability to wash the harvested cells in order to remove the growth and/or disassociation media is highly desirable. We offer both cleanable and single-use solutions that meet these requirements. Our single-use solutions reduce the need for special cleaning regimes, decreasing equipment set up, idle time and changeover time. It also eliminates the need for additional infrastructure such as Sterilize-in-Place and Clean-in-Place skids.

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Microbial Fermentation

Microbial Fermentation requires robust, scalable equipment with high g-forces. Our stainless steel Powerfuge® line is fully scalable and can achieve g forces of up to 20,000 x g.

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