In the pharmaceutical industry, efforts to manufacture biopharmaceuticals (*1) are accelerating around the world. In the active-pharmaceutical-ingredient-purification process of biopharmaceutical manufacturing, proteins, peptides, and other materials are generated by applying genetic modification technologies, which is followed by the process of separating the active constituents. Chromatography is an important technology that ensures the safe separation of active constituents with a high level of precision. To separate the active constituents in an active pharmaceutical ingredient, chromatography technology uses a container called a "column," which contains a filler, and forces the liquid raw material to pass through this column. The constituents of the liquid raw material travel through the column at different speeds, which causes them to separate and allows for the desired constituents to be collected. Separation and purification technologies that make it possible to obtain constituents of a higher purity more efficiently are in high demand in the manufacturing of biopharmaceuticals, a field that continues to grow more advanced.
2015
September 11, 2015
Kurita Develops the KuriPrep® ULC Series Chromatography Devices for Biopharmaceuticals
Tapping the Biopharmaceutical Market by Offering a Lineup of Devices for a Wide Variety of Purposes that Range from the Manufacture of Investigational Agents to the Commercial Production of Biopharmaceuticals
Kurita Water Industries Ltd. (Head Office: Nakano-ku, Tokyo; President: Toshiyuki Nakai) is pleased to announce that it has become the first manufacturer in Japan to develop chromatography devices, which are used to separate the active constituents (active pharmaceutical ingredients) of biopharmaceuticals during the manufacturing process. These devices feature a column structure that has been optimized for biopharmaceuticals through the application of Kurita’s computational fluid dynamics (CFD) technology. This structure enables the devices to consistently separate and purify constituents at a high level. Kurita will expand the sales of these devices in a bid to tap into the promising biopharmaceutical market.
Exterior of a KuriPrep® ULC series device
For more than 30 years, Kurita has been engaged in the chromatography business for primarily small-molecule synthetic pharmaceuticals. Aiming to expand business into the biopharmaceuticals market, which is expected to grow in the future, Kurita began developing a column for separating and purifying the ingredients of biopharmaceuticals by making use of the technologies it has developed over many years of operation. To maximize the inherent performance of fillers, the company has optimized the structure of the column by creating one that evenly disperses the liquid of the active pharmaceutical ingredient over the entire packed bed surface in the column. This optimization was performed by applying computational fluid dynamics (CFD) technology, a unique technology Kurita has developed for simulating the flow behavior of liquids in the column. As a result, Kurita became the first manufacturer in Japan to succeed in developing chromatography devices for biopharmaceuticals. Kurita will promote these devices as the KuriPrep® ULC series, which will serve as a series of chromatography devices for biopharmaceuticals that ensure a high level of separation performance.
The KuriPrep® ULC series devices make use of axial compression technology, which uses a piston to apply ultra-low pressure to the filler. This ensures the quick, easy formation of a good, evenly packed bed in the column, even when the column is large or the filler exhibits a high rate of sedimentation. In addition, the devices are the first to allow for the column containing the filler to be removed while pressure is being applied by the chromatography devices. This enhances the level of convenience and productivity for customers. The combination of the piping design that does not retain any fluids and a liquid-sending system which employs a high-performance pump ensures highly precise separation and purification with a high degree of reproducibility. The lineup also includes a small-scale device for manufacturing the investigational agents (*2) used in research and development, as well as a large-scale device for commercial production. These devices are compatible with any filler.
Moving forward, Kurita will continue offering devices that satisfy the diverse needs of customers, helping to improve quality and make technological innovations in pharmaceuticals, while also providing consistent customer support that covers the maintenance of delivered products.
- *1Biopharmaceuticals are pharmaceuticals with active ingredients that are produced from protein-derived or biological materials. Biopharmaceuticals feature larger molecules and more complicated structures than chemically synthesized small-molecule pharmaceuticals. In most cases, the properties of biopharmaceuticals depend on the actual manufacturing processes used to create them.
- *2 An investigational agent is a chemical in the phase in which its effect in treatment is being tested before permission to produce it is granted by the regional or national government.