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Nehal Patel's Webpage

Photo of Nehal Patel
Postgraduate Researcher

Email:nehal.patel.12@ucl.ac.uk
Address:
Department of Biochemical Engineering
University College London
Torrington Place
London WC1E 7JE
United Kingdom

Nehal Patel received his degree in Chemical Engineering from Imperial College London in 2012. He is now pursuing an Engineering Doctorate (EngD). He is working within both the Biochemical Engineering and Chemical Engineering departments at UCL. The EngD is in collaboration with BioMarin.

Research project

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Title: Comparison of Chromatographic and Aqueous Two-Phase Systems for the Separation of Novel Biopharmaceuticals

Supervisors: Dr Eva Sorensen and Dr Daniel Bracewell (Biochemical Engineering, UCL)

Due to the success of the therapeutic proteins, there has been an increasing amount of pressure on industry to keep up with patient demand. As a result, there has been an increasing amount of research & development (R&D) aimed at improving upstream efficiency. The fruits of this labour have resulted in larger cell titres during the cell culture/fermentation stage of the manufacturing process. However improvements in product titre and upstream efficiency have resulted in the productivity (and cost) bottleneck being shifted to downstream processing where separation equipment such as expensive chromatography columns must be scaled accordingly to cope with the increasing amounts of material generated. For example industrial scale protein A chromatography operations can cost as much as $1.5 million a year bringing the total costs of downstream processing to as much as 80% of total manufacturing costs. Such high costs highlight the importance of re-evaluating current strategies/methodologies in the design of downstream processing.

Aqueous two-phase extraction is a promising alternative downstream processing technology; it is similar in operation to conventional liquid-liquid extraction using organic solvents however water is the only solvent therefore these aqueous based systems are more suitable for fragile/sensitive biopharmaceuticals.

The aim of this research project is to establish a methodology for the comparison of chromatographic and aqueous two-phase systems utilising both mechanistic models and high-throughput experimental technologies. The integration of both modelling and experimental technologies should allow for better decisions to be made with regards to process development. In addition, the overall amount of experimentation and hence resources should be reduced as a result of combining both types of development strategy. Such an approach also promotes greater fundamental product/process understanding which is at the heart of the Quality by Design (QbD) initiative implemented by the U.S. Food and Drug Administration (FDA). The resultant methodology should be general and therefore applicable to a wide range of systems.

The unique collaboration with BioMarin will allow for this work to be tested in an industrial environment which should allow for the validation of the proposed approach in real case studies.

Page last modified on 11 mar 13 13:59