Indena opens new HPAPI kilolab
Pharmaceuticals company Indena has opened a new kilolab in Milan, Italy, dedicated to HPAPIs (natural, semisynthetic and total synthetic). The new kilolab is designed to handle the production of toxic substances characterised by an occupational exposure limit (OEL) of 20ng/m3.
The design of the new kilolab assures complete compliance with cGMP guidelines, offers maximum protection against cross-contamination and allows chemists to handle hazardous materials in an environment with the highest levels of safety. The kilolab 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.
Pietro Allegrini, R&D director at Indena, said: “Opening the new year with the new kilolab running is a promise fulfilled. 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 and cGMP batches for clinical trials to large-scale commercial manufacturing.”
New plant on the way
The new kilolab will be followed during 2018 with 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.