Indena Opens New Kilolab In Italy Dedicated To High Potency APIs

Indena, an Italian company specialised in the isolation, development and bulk-manufacturing of APIs from natural sources, recently opened a new kilolab dedicated to HPAPIs (natural, semisynthetic and total synthetic) in Settala (Italy). The company said the production of the first total synthetic HPAPI has been successfully in the new kilolab.

The new kilolab is designed to handle the production of toxic substances characterised by an Occupational Exposure Limit (OEL) of 20 ng/m3. The lab is said to deploy innovative technologies for containment, preventing the accidental release of HPAPIs outside the containment areas. “The lab is able to perform full synthesis and HPAPIs contract development and manufacturing services, including extraction, isolation, purification and synthetic modifications for active pharmaceutical ingredients on a wide range of scales,” the company said in a press note. “We can produce clinical or industrial batches and perform full synthesis, building on our deep expertise in cytotoxic and high containment. We are now able to handle products and processes from small scale GLP batches for toxicology, cGMP batches for clinical trials to large-scale commercial manufacturing,” commented Mr. Pietro Allegrini, R&D Director at Indena.

The new kilolab will be followed during 2018 by the building of a new multi-purpose pilot plant, designed for grinding, extracting and purifying toxic plants. It will also be equipped with columns for chromatographic purification and endowed with semi- and total synthesis capabilities.