Indena offers a full range of manufacturing capabilities for pharmaceutical ingredients, and services such as the extraction, isolation and purification of natural derivatives and the process, R&D and manufacturing of synthetic molecules.
The combination of Indena’s expertise with state-of-the-art facilities allows the company to deliver products and processes from small-scale orders for GMP batches for clinical use to large commercial manufacturing supplies.
With the aim of providing customers with an increasing breadth of services, the company has been investing in the implementation of cutting-edge technologies, and mainly in the expansion of the GMP pilot plant and in the upgrade of the spray drying technology already existing in the company’s plant.
Moreover, with its highly specialized Quality Assurance system and Regulatory expertise, Indena is able to meet the strictest requirements from regulatory agencies.
Indena is therefore a full service provider and a reliable partner in the cGMP Contract Development and Manufacturing of Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPIs).
The first news from Indena’s CDMO services is related to its kilo lab LK2 for OEB 5 products, which doubled its capacity. The new kilo lab is capable of practicing Indena technologies on a large scale, with 60 liter reactors. This expansion completes Indena’s production capacity towards HPAPIs, allowing the company to offer different capacities for products at the highest power level (OEL 20 ng / m3 – OEB5).
To face market requests in the most efficient and flexible way, Indena will be installing a 250-liter hydrogenator which will be ready at the end of 2022. Together with the existing 20-liter hydrogenator, the new one will allow Indena to satisfy a wider demand for this kind of service.
Another Indena’s goal is to offer customers the possibility of carrying out synthetic processes even in a wide range of conditions for both natural molecules that require semisynthetic steps, and for synthetic molecules. That’s why Indena has complemented its GMP Pilot Plant for APIs with a second facility equipped with reactors up to 10,000 liters. That way, the system has been upgraded in order to exploit Indena’s tehcnologies at a larger scale.
Moreover, Indena has been working on the expansion and upgrade of its mid and large scale spray dryers, working with organic solvents.
The recent installation of the Niro PSD2 spray dryer ATZ5, which allows an intermediate production scale and guarantees a good containment (usable for products also classified as OEB4 as a hazard class), has been joined by the revamping of a spray dryer ATZ4, already used in Indena for several years.
The ATZ4 has a production capacity of 3-4 times higher than PSD2 thus allowing services on a larger scale in this specific area and completing the Indena CDMO offer.
