The lesson by Alessio Bove, our Pilot Plant Manager at the Italian Dipharma Francis site in Mereto di Tomba (UD), has become a fixed appointment in the University of Pavia’s Master in Drug Design and Development.
For several years now, our colleague Alessio Bove has been invited annually to share his expertise. Last week, on June 14, at the 2024 edition of the Master, Alessio presented “API Production: Technology Transfer and Troubleshooting Management”.
How does Dipharma ensure its processes are robust and reproducible? How does the company assess the safety of new processes? Can Dipharma consistently meet customer deadlines?
Alessio addressed these questions in his presentation and detailed how technology transfer is a pivotal phase in drug development, greatly influencing the success of both product development and subsequent commercial manufacturing.
He explained Dipharma’s approach to mastering this complex step by:
- Gaining comprehensive insights into potentially critical process parameters during the familiarization and optimization stages of process development.
- Conducting systematic HazOp studies with multidisciplinary teams of experts to identify and mitigate hazards, ensuring the best solutions for process safety management.
- Implementing a thorough risk management strategy during the preliminary stages of industrial scale-up planning.
Alessio Bove also highlighted Dipharma’s commitment to meeting deadlines through a transparent and realistic timeline estimation process. This is grounded in our extensive experience and aligned with customer expectations. Our approach involves keeping clients thoroughly informed throughout the process, ensuring clear and consistent communication about project progress. This transparency builds trust and assures clients of our dedication to delivering on time.
Our unwavering commitment to robust and reproducible processes, comprehensive safety evaluations, and adherence to production timelines reinforces our pledge to provide the highest quality products and services to our clients.
To know more how we can support you, taking care of your projects, please contact us.
