How does Dipharma ensure its processes are robust and reproducible? How does the Company evaluate the safety of new processes? Does Dipharma always manage to meet customers’ deadlines?
The answers to these and other questions have been provided by our colleague Alessio Bove, Pilot Plant Manager, during his presentation titled “API production: technologytransfer and troubleshooting management”, held at the 2023 edition of the Master in Drug Design and Development at the University of Pavia (Italy) on June 30.
Alessio Bove explained that the technology transfer is a critical step in any drug development program and can significantly impact the success of a product’s development and, ultimately, of its subsequent commercial manufacturing.
He highlighted how Dipharma successfully manages this complex step. First, by developing an in-depth knowledge of potentially critical process parameters during the familiarization and optimization stages of development. Then, carrying out a HAZOP studies, conducted by multidisciplinary teams of experts which use a systematic approach to identify possible hazards and develop the best solutions about process safety management. Afterward, implementing a careful risk management strategy conducted by the project team during the preliminary stages of industrial scale-up planning.
With reference to the adherence to the deadlines, Alessio Bove focused his attention on how transparently Dipharma, based on many years of experience, always starts from a realistic estimation of the timelines, in alignment with customer’s expectation.
If you would like to know more about Dipharma’s technology transfer, troubleshooting management and its high quality CDMO services, please contact us. Our experts will be pleased to assist you and answer your questions.
Alessio Bove’s lesson follows the March 2023 presentation, “Research and Development in a company producing APIs”, held at the same Master by our colleague Simone Mantegazza, Research Laboratory Manager.
Dipharma strongly believes in the development of a trusting, committed and interactive relationships between the industry and the university for increasing innovation and competitiveness. Furthermore, strong relationships offer the possibility to work on cutting-edge technologies and gain practical experience to the students.
To learn more about the Master: https://psfmaster.unipv.it
Dipharma Francis S.r.l.