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Indena Further Expands GMP Pilot Plant for APIs

Doubled kilo lab LK2 for OEB 5 products and installed a 250-liter industrial hydrogenator.

By: Kristin Brooks

Managing Editor, Contract Pharma

Indena has further expanded its existing GMP Pilot Plant for active pharmaceutical ingredients, doubling kilo lab LK2 for OEB 5 products and installed a 250-liter industrial hydrogenator. Indena is presenting these latest innovations at DCAT 2022. 
 
“Aiming to provide customers with an increasing breadth of services, we have been investing in the implementation of cutting-edge technologies while capitalizing on decades of know- how in the field of complex molecules,” said Stefano Togni, Chief Commercial Officer of Indena S.p.A. “The combination of Indena’s expertise with state-of-the-art facilities allows us to deliver products and processes that range from small-scale orders for GMP batches for clinical use to large commercial manufacturing supplies.” 
 
In 2020, Indena completed the installation of a GMP pilot plant, complementing its industrial capacity. Recently, Indena has been working on further expanding its GMP pilot plant with a second suite equipped with 10,000 L reactors. Indena aims to offer customers the ability to run synthetic processes in a wide range of scale and conditions for both natural molecules, semisynthetic and fully synthetic ones. 
 
Indena has more than doubled the capacity of its kilo lab LK2 for OEB 5 products, capable of running larger-scale (60 L) reactions. This expansion completes Indena’s production capacity for HPAPIs, allowing the company to offer different capacities for products at the highest containment level (OEL 20 ng/m3 or OEB5). 
 
The company also installed a 250 L hydrogenator, which will be ready by 2022. Together with the existing 20 L hydrogenator, the new one will allow the company to meet market requests, also for this kind of chemical reaction, in an efficient and flexible way. 

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