| May 20, 2014 |
Microparticles as a protein trap (w/video)
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(Nanowerk News) Most medicines sold today are produced biotechnologically. A new cleaning method developed at the Austrian Centre of Industrial Biotechnology (acib) combines five purification steps and extremely facilitates the workup process. These microparticles technology is already used at Boehringer Ingelheim.
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Seven of the ten best-selling drugs in 2012 were biopharmaceuticals. Biotechnology in pharmaceutical production is still growing. A severe problem is the cleaning of manufactured products using various cell lines; up to 80 % of the total production costs are spent for purification. The Austrian Centre of Industrial Biotechnology (acib) has developed a method based on microparticles, which reduces five purification steps to only one; a revolution in the cleaning process of biopharmaceuticals.
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“Our micro-particle project comprises a new cleaning method especially for proteins for medical application, which are produced by microorganisms. Highest quality and purity are key parameters in the production of biopharmaceuticals. Using our microparticles, the manufacturing process of biopharmaceuticals becomes qualitatively better and faster”, explains Prof. Bernd Nidetzky , CSO of acib (Austrian Centre of Industrial Biotechnology). The new process was developed within a cooperation project of acib and Boehringer Ingelheim RCV Vienna.
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“Five in one”
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“The economic relevance of this new method lies in its simplicity and speed. We aggregated five process steps into a single one”, says Georg Klima, head of Process Development Biopharma at Boehringer Ingelheim in Vienna. “In addition, we expect an even better quality because the microparticles directly absorb the product out of the cells with high specifity. “Thus we get a much purer product than with conventional methods.” A key issue was the transfer of technology from research into corporate laboratories, which was completed within a few weeks. Georg Klima: “For joint projects, we know the importance of technology transfer. That is one of the reasons why the cooperation with acib is going so well.”
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Details about the microparticle technology
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Currently, chromatography is used for standardized protein purification. Production cell factories like microorganisms are first “cracked open”. Subsequently, the cell supernatants flow through packed chromatography columns, where the target proteins are separated from the rest. However, this is easy only in theory. In reality, industry fights with slow binding rates, clogged or damaged material due to the required high pressure, product losses and other obstacles.
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The new acib system works differently: Instead of packing a carrier into columns, scientists have prepared tiny, charged microparticles with a size of one to two microns. “These particles are excellent, fast protein traps with a high capacity”, explains Prof. Alois Jungbauer, “they can bind up to 150 milligrams of protein per gram of particle material”. The entire binding operation is completed within 30 seconds. Classic chromatographic purification methods take hours. Like these the micro particle technology is based on the ion exchange principle.
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Additionally, a continuous process based on the micro particle technology has been established in order to further accelerate the biopharmaceutical purification in industrial scale. As this new technology can overcome many limitations in the processing of valuable proteins, two patents are pending for the method. The acib partners Boehringer Ingelheim and Sandoz have started to take over the microparticle technology in their production processes.
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