Indena is installing in 2019 two new suites, to keep on offering top level CDMO services: a new pilot pharmaceutical plant dedicated to productions requiring a small scale and high flexibility, and a PSD2 spray dryer to complement the one already operated by the company.
2019 is a year of important investments for Indena to further improve its technological assets: two new suites will be available at the company, in order to keep on offering its customers top level CDMO services.
First, Indena is installing a pilot pharmaceutical plant at the Settala main production site, in order to be equipped with a plant able to include all the technologies the company already uses, but dedicated to productions requiring a smaller scale and high flexibility.
The new pilot plant will allow Indena to produce APIs for clinical trials (up to phase 3) and for small commercial requirements, assuring a complete compliance with cGMP guidelines. It will work for extraction, chromatographic purification and synthesis. Equipped with hastelloy, glass lined, stainless steel reactors, the new pilot plant can manage processes at a temperature ranging from -80°C to +200°C; it has a reactors capacity range from 200 to 1000 liters, suitable for batches from few kg to 30/50 kg of APIs. The pilot plant will be fully operational starting from next June.
The second new investment Indena is working on is related to spray drying from organic solvents, an activity that Indena has been carrying out since more than 20 years. Indena is installing a PSD2 spray dryer, which is complementing a large scale one already operated by the company.
The PSD2 new spray drying system is a medium size equipment to serve clinical and commercial needs. The new equipment can handle organic solvents and is designed to carry out the production of APIs and pre-formulated APIs (through spray drying in the presence of excipients) with an Occupational Exposure Limit (OEL) of ≥10 μg/m3. The new spray dryer will be available from June 2019 and will be completed with ancillary equipment to manage all the production processes.A further expansion is already planned and foresees the installation of another new smaller spray dryer (evaporation rate of 2 kg of water per hour), able to handle APIs with an OEL of ≥1 μg/m3 .
With these further investments Indena confirms its strong will and engagement in the area of CDMO services, with the aim to continue being the most reliable partner for companies looking for state-of-the-art technologies and high level services.