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Development and implementation of a platform to high throughput process development (HTPD) for the development of processes of bioproducts purification using chromatographic resins and magnetic materials from Kopp Technologies

Abstract

The purification step is commonly considered the "bottleneck" of productive processes to bioproducts obtainment. In the case of biopharmaceuticals, which are the most demanding bioproducts in terms of quality, competitivity and regulatory factors the development of purification processes needs to be faster and more cost-effective, meeting the quality requirements for the product and the process. The biopharmaceuticals have been the main responsible for the growth of the pharmaceutical industry in recent years (including in Brazil), this change in the profile of the drug market has demanded by the continuous development of new drugs and consequently by more efficient processes of production and purification of these compounds. The Kopp Technologies is a spin-off of the Chemical Engineering Department of UFSCar that was created in 2015 to provide in the Brazilian market innovative and scalable solutions for the purification of chemical compounds, mainly bioproducts, taking advantage of technologies and the know-how obtained in the last 30 years in the DEQ-UFSCar. The company was created to take advantage of the great potential of magnetic adsorbents developed in the DEQ-UFSCar, but after contact with customers we observed that there was a great industrial demand for chromatographic resins. We have technology to produce porous silica for use as chromatographic resin with 3 different pore structures and 5 particle size ranges, as well as technology to produce magnetic adsorbents in 3 particle size ranges. We developed 34 methods for the modification of the surface chemistry of magnetic adsorbents, later we adapted these methods to modify the surface chemistry of our resins, these materials were successfully tested in conceptual purification processes. Currently we have processes to modify the surface chemistry of our materials with hydrophobic groups (14 processes), reactive groups (4 processes), positively charged groups (10 processes), negatively charged groups (3 processes) and chelates for purification of Poly- His proteins (3 processes). During the introduction of these products in the market we identified that our customers do not wish to buy magnetic adsorbents or chromatographic resins, they simply want a purified product, often they have no idea of how to develop a purification process. We saw in this need a market opportunity to increase the sales of our products and to compete (with advantage) with foreign companies. So, we restructure our business model and we became a company that sells solutions for purification, we sell services in the development of purification processes using our products, and later we sell inputs for our customers to industrially implement those processes. However, this business model has created an additional problem, the need to develop very fast, cost-effective, scalable and fully optimized processes at affordable costs. In this context, we will develop a platform for High Throughput Process Development (HTPD) of purification of bioproducts using chromatographic resins and magnetic materials developed by our company. An HTPD platform is a concept in process development that has been used very recently by large pharmaceutical companies for rapid development of biopharmaceutical production and purification processes. An HTPD platform combines High Throughput Screening (HTS) with Design of Experiments (DoE), statistical analysis and decision-making tools that allow to quickly develop optimized processes. The technology that will be developed through this project will allow our company to provide accessible services in the development of highly cost-effective and efficient industrial processes, solving an extremely relevant and strategic problem of the Brazilian biotechnology industry. According to our business model the HTPD platform will boost the sales of our products that have already been developed with FAPESP resources and revert royalties to the institution. (AU)

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