PLASTICBIOPHARMAPUR · Separation and purification of biopolymers and biopharmaceuticals using advanced chemical engineering tools

Separation and purification of biopolymers and biopharmaceuticals using advanced chemical engineering tools

Nuno M. Reis, Malcolm R. Mackley Department of Chemical Engineering and Biotechnology University of Cambridge, United Kingdom (UK) Platform technologies currently used in preparative or analytical steps throughout the production process of biopolymers with therapeutic interest (biopharmaceuticals), such as chromatography and electrophoresis, are ineffective for lacking the required levels of throughput and delivering variable performance at high price and limited disposability. The IEF project carried out for 24 months aimed developing novel advance tools for robust, low-cost separations and purification and biopharmaceutical products based on a new semi-disposable, high-throughput, non-porous microengineered material recently invented at the University of Cambridge, UK. A number of scientific and technological developments allowed delivering three new modular conceptual devices for the intensification of chromatographic, electrophoretic and inactivation processes, relevant to bioprocessing and healthcare market sectors. The new systems offered high accuracy, reliability and disposability with significant reductions in instrumentation cost over conventional platforms. Firstly, the new material was chemically derivatised with charged groups for the production of a cationic and an anionic chromatographic columns. The new ion-exchange columns were then used to separate proteins with close isolectric points using superficial flow velocities up to 50 times faster than those currently used in packed bed chromatographic columns, as the new material presented restricted mass transfer limitations. High voltages were then applied in the second design concept used for the separation of proteins using isoelectric focusing concept. The new apparatus allowed fast separation of proteins with isoelectric points different less than 0.1 pH units. Both the chromatography and electrophoresis devices are scalable and offer real-time information of the bioseparation processes. The same material was also used in the core of a third device, used for virus inactivation in concentrated protein solutions. Trial experiments at the virology division at Addenbrooks Hospital, Cambridge, have demonstrated that a good degree of inactivation of a large enveloped virus can be accomplished in about two seconds in the new device, compared with the >15 s commonly used with competing inactivation technologies. A number of biopharmaceutical companies has already shown interest in the new technology concepts. A leverage development outcome from the scientific research carried out in this IEF project was a new microscale platform for fast, quantitative detection of multiple analytes within biological samples using enzyme-linked immunosorbent assay's concept. Immunoassays are the most widely used biochemical tools that allows the detection of very small concentrations of analytes in biological samples, such as antibodies, hormones or drugs, therefore finding a number of important applications from environmental control to forensic analysis and clinical diagnostics. Similar sensitivities were experimentally obtained with the new immunoassay technique during detection of different substances of clinical relevance when compared to an optimised ELISA detection in a microtiter plate based immunoassay; however, the investment cost for the signal detection equipment could be reduced by at least two orders of magnitude. Other studies have shown the feasibility of the new concept for multiple, simultaneous analyte detection. A patent was secured by Cambridge Enterprise in March 2010, covering a number of inventive steps in the manufacturing and application of the new immunoassay platform. This constituted the case for a 12-month, £160 000 follow-on funding application supported by BBSRC in March 2010, from which the first product is being prototyped by a renown team of product designers in UK and detailed market information was obtained with the involvement of an I-TEAMS project.

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