This thesis is the results of a High-level Apprenticeship PhD realized thanks to the collaboration between Huvepharma Italia s.r.l. and the University of Turin - Department of Chemistry. Huvepharma Italia s.r.l. is a multinational pharmaceutical company located in Garessio (CN), north-western part of Italy, and consist of a complete independent and autonomous development and manufacturing unit acquired from Sanofi since May 1st 2016. The product development and manufacturing facilities, operate in accordance with the most stringent quality, environmental, safety and industrial hygiene regulatory requirements, to provide a very flexible capacity for developing, industrializing and producing APIs and intermediates for human and animal health. As PhD candidate I have been asked to develop and/or optimize synthetic processes in order to produce API/pharmaceutical intermediates on industrial scale having, in the meanwhile, a special focus on biocatalytic approaches as an alternative to classical organic synthesis. Be part of such an organization meant not only dealing with a process from a chemical laboratory at R&D level but also to scale-up the process in an industrial plant, calculate its dangerousness, solve the problems related to the plant, present the results obtained knowing the needs of customers and be able to meet them under the required constraints, work on the analytical methods necessary to determine the quality of the final product, coordinate the work with the functions involved and much more. All this with one foot left in the world of research. I am grateful to have had this stimulating opportunity. Details concerning compounds, methods, customers and documents are protected by trade secret.
New unconventional processes to improve production efficiency of APIs
Maffeis, Elia
2023-01-01
Abstract
This thesis is the results of a High-level Apprenticeship PhD realized thanks to the collaboration between Huvepharma Italia s.r.l. and the University of Turin - Department of Chemistry. Huvepharma Italia s.r.l. is a multinational pharmaceutical company located in Garessio (CN), north-western part of Italy, and consist of a complete independent and autonomous development and manufacturing unit acquired from Sanofi since May 1st 2016. The product development and manufacturing facilities, operate in accordance with the most stringent quality, environmental, safety and industrial hygiene regulatory requirements, to provide a very flexible capacity for developing, industrializing and producing APIs and intermediates for human and animal health. As PhD candidate I have been asked to develop and/or optimize synthetic processes in order to produce API/pharmaceutical intermediates on industrial scale having, in the meanwhile, a special focus on biocatalytic approaches as an alternative to classical organic synthesis. Be part of such an organization meant not only dealing with a process from a chemical laboratory at R&D level but also to scale-up the process in an industrial plant, calculate its dangerousness, solve the problems related to the plant, present the results obtained knowing the needs of customers and be able to meet them under the required constraints, work on the analytical methods necessary to determine the quality of the final product, coordinate the work with the functions involved and much more. All this with one foot left in the world of research. I am grateful to have had this stimulating opportunity. Details concerning compounds, methods, customers and documents are protected by trade secret.
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