Founded in 1998, Mipharm is now a Centre of Excellence for contract manufacturing, for the development of new products, for special services to the pharmaceutical industry and for the development of innovative technological platforms. All this condensed into a company created out of the spin-off from the production site (former Sandoz factory) in Via Quaranta, Milan, acquired by a group of former Novartis managers led by Giuseppe G. Miglio, who headed the company until December 2016, when ownership passed to the private equity fund Mandarin Capital Partners II, investing heavily in innovative technologies. In March 2022 ownership passed to the private equity fund Alto Partners and Maurizio Silvestri continues to serve as President and CEO.
“The aim of the acquisition is to develop Mipharm’s potential through a sustainable growth project whose goal is to act as an aggregation hub in the Contract Development & Manufacturing sector (CDMO)” highlights Maurizio Silvestri. “Over the years, Mipharm has become a fully integrated pharmaceutical company with a modern, active production site that both produces and packages a wide range of drugs on a contract basis and researches and develops new products for its customers, supported by a well-structured R&D department. Its Special Services Business Unit was specially created to serve the pharmaceutical industry in three areas – new product development, QA and QC services, and clinical trial logistics management. Bolstered by its consolidated experience, the Special Services Business Unit is able to act as a comprehensive partner throughout the product development process. Recognising the importance of having a highly qualified team, Mipharm has invested significant resources over the years in creating a high-tech production site that can meet its customers’ requirements. It is now equipped to produce and package a broad spectrum of products. The company’s latest investment is an IMA 600-litre granulation system. We felt that IMA Active was the ideal partner for designing and manufacturing a cutting-edge, multi-purpose granulation system. The collaboration with IMA, involved at the engineering and process level thanks to its test laboratory, has enabled us to size the system precisely to our contract manufacturing needs. The system is versatile and ready to handle various types of processes, from wet granulation with both HSMG and fluid bed, and for water-based and organic solvent-based processes. We can also use the fluid bed for coating granules and pellets, to produce more sophisticated pharmaceutical forms with more complex formulations where processing can affect the release profile of the active ingredient. In short, we have the right amount of flexibility to meet market requirements with maximum efficiency and speed”.
Let’s look back to how the project began: it all started by choosing a Mylab with a fluid bed module. What were your requirements?
“The project started out with a laboratory-scale Mylab fluid bed designed for small batches of approximately 3 kg.” Answer Camillo Bologna Mipharm Chief Scientific Officer.
“Thanks to interchangeable product containers, Mylab enables our R&D department to develop granulation and coating processes with top and bottom spray techniques. All this with experimental designs on small trials and minimum quantities of material”.
A 600-litre granulation line was acquired after a few months. What were the reasons behind this choice? How decisive was the support of the IMA Active Laboratory?
“The system’s reliability, flexibility and customization are the three characteristics of the IMA granulation system that attracted us the most”. Continues Elena Oggioni Mipharm Production Manager. The experience at the IMA Active Laboratory was decisive as well as the training for the use of the new plant which allowed us to acquire from the early stages a certain confidence and enthusiasm in the usage of such a highly automated system.
The tests run on Mylab will enable us to scale up quickly our processes from the pilot to the production system, and permit to select and test the most suitable techniques and process in order to match at the best our customers’ requests (product transfer, new formulation development) always with the focus aim of continuous improvement with safety, sustainability and quality requirements compliance.”
For the fluid bed, you opted for bottom spray technology. What advantages has it given you?
“Bottom spray technology gives extremely high quality uniform film very quickly, even with very small particles such as granules or pellets, as well as various types either aesthetic or functional coating, such as taste masking or modified release.
Such technology is already part of Mipharm’s know-how in a specific department dedicated to a single specialty, the introduction of a second line with the similar technology will allow to attract new businesses and to increase flexibility.
IMA Active proposes a modular solution for bottom spraying that allows you to change the air distributor and the spray nozzle to obtain optimal product fluidisation and maximum yield.”
What are the overall strengths of your granulation system?
“Aside from those already mentioned, the IMA 600-litre granulation line allows us to meet a vast range of production demand” answer Elena Silvani Mipharm HSE Manager. “The line can work fully automatically, keeping all transfers contained so as to safeguard the operators’ health and safety limiting exposure to the product and at the same time the risk of cross-contamination. The line is equipped with an automatic “clean in place” system which makes cleaning easier and more repeatable, managing at best the usage of water and energy with the result of protecting the environment and cutting system downtime when switching production to a different product”.
Where is the installation at now?
“We have completed the tech transfer activities of a key product and we are arranging the necessary regulatory activities to start definitely for commercial purposes”, answers Camillo Bologna.