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 an SAL level of 10<sup>–6</sup>.
The Challenge
A biotherapeutics company was using a bottle centrifuge to collect and concentrate viable T-cells and was obtaining unsatisfactory product recovery. Note that bottle centrifuges are not closed systems and are difficult to scale. And, due to the manual processing of the bottles in the biosafety cabinet, the variability run to run is higher than an automated system and the contamination risk is increased.
We Used
The UniFuge® Pilot. The UniFuge products enable low-shear cell harvesting and washing of the cells, resulting in high cell viability and recovery. In addition, they are closed systems that enable sterility with single-use modules that have an SAL level of 10<sup>–6</sup>. We also recommend the UFMini®, a tool that can be used to conduct Design of Experiments (DoE) and further characterize the process as a scale-down model.
The Outcome
CARR Biosystems achieved up to 98% recovery with 93.2% viability, in a closed, sterile environment with no cells detected in the centrate. The UniFuge ensures that the cultures are healthy and also facilitates future scaling-up and process consistency.
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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.
The Challenge
A company producing gene therapies using HEK293 cells was unsatisfied with the clarification performance of filtration as measured by NTU values. Their filtration process could not be efficiently scalable.
We Used
The UniFuge® Pilot. The UniFuge is ideal for delicate cultures and replaces filtration during primary recovery, eliminating the issue of filter clogging and increasing product recovery. We also recommend the UFMini® as a tool to conduct Design of Experiments (DoE) and further characterize the process as a scale-down model.
The Outcome
CARR Biosystems’ UniFuge demonstrated superior clarification performance to filtration in terms of greatly reduced NTU values, along with an increase in titer in the resulting centrate. The NTU values were reduced 80 to 90%. Processing time was also significantly reduced.
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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.
The Challenge
A company using the MRC5 cells grown in a fetal bovine serum to develop a vaccine needed a practical solution to keep bovine serum albumin (BSA) levels < 30 ng per dose to comply with WHO requirements.
We Used
The UniFuge® Pilot was used for cell harvesting, concentrating and washing the cell slurry prior to discharge. Single-use modules have the potential to eliminate complex and expensive downstream purification steps. Also, the UniFuge is a closed system that minimizes the risks of contamination and is fully scalable.
The Outcome
Using the UniFuge allowed the team to maintain a closed system and to achieve the desired results within the required BSA limits, enabling safe vaccine production at scale. When using the single-use modules, studies have shown that 4 to 5 bowl volumes of buffer (8 to 10 liters) resulted in a wash efficiency of 99%.
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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.
The Challenge
A company producing recombinant protein in high-density CHO cell cultures was searching for an efficient solution to separate the desired protein from the cell culture broth and to eliminate primary filtration.
We Used
The UniFuge® Pilot was used to explore processing of CHO cell culture broths. Our scalable single-use and stainless steel solutions offer the ability to fully eliminate stage one filtration while increasing product recovery. The ability to scale up to the U2k (with its high capacity) and to scale down to the UFMini (with its small capacity) makes the UniFuge family a great fit for the needs of CDMOs and Originator companies.
The Outcome
We were able to successfully separate the desired protein from the broth coming from a single-use bioreactor at a rate of 4 L/min. With the low-shear inlet and non-shear discharge mechanism, it was possible to remove the cells and cell debris and achieve the desired 10 NTU result of centrate prior to the 0.2-micron filter.
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NUCLEIC ACIDS
When producing plasmids, scalability and large volumes are crucial.
The Challenge
A biopharma company working on a COVID-19 vaccine needed an efficient solution to collect centrate of soluble mRNA from a E.coli feed stream known to be shear-sensitive.
We Used
The UniFuge® Pilot was used. The UniFuge offers low-shear separation and linear scalability. We recommend the UFMini® as a tool to conduct Design of Experiments (DOE) and further characterize the process as a scale-down model.
The Outcome
Our UniFuge successfully achieved product recovery of over 92%, with no shearing.
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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.
The Challenge
A company needed a solution to collect and concentrate and wash animal suspension cells grown in a bioreactor. The cells were considered fragile and required a fast-processing time for quality and cost purposes.
We Used
The UniFuge® Pilot was selected. The UniFuge is a low-shear technology that promotes fast processing time. We recommend the UFMini® as a tool to conduct Design of Experiments (DOE) and further characterize the process as a scale-down model.
The Outcome
Cells were successfully processed from the bioreactor through the centrifuge and into a product collection vessel. We successfully captured and concentrated the cells during the centrifugation process and washed the resulting cell slurry prior to discharge from the single-use module.
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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.
The Challenge
A company was using a bottle centrifuge to separate an inclusion body protein from E.coli. The batch centrifuge process was considered labor intensive and time consuming and they were looking for a better solution.
We Used
The Powerfuge® Pilot was selected. Our stainless steel Powerfuge line is fully scalable and can achieve g forces of up to 20,000 x g, the highest g force in the market.
The Outcome
The Powerfuge was able to reduce the labor involved and the run time. It also enabled the company to double the concentration of the E.Coli feed and to achieve the same separation performance.
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Our wide range of separation solutions enable robust scale-up and scale-down and facilitate the transfer of operating protocols from early-stage development to commercial manufacturing and licensure.
