Indena recently opened in Settala a new kilolab dedicated to HPAPIs (natural, semisynthetic and total synthetic), which capitalizes on the long-lasting experience of the company in the area of high containment. The production of the first total synthetic HPAPI has been just completed in the new kilolab.
The new kilolab is designed to handle the production of toxic substances characterized by an Occupational Exposure Limit (OEL) of 20 ng/ m3: it implements the best available security procedures for people working in the lab and it deploys the best and most innovative technologies for containment, preventing the accidental release of HPAPIs outside the containment areas, including the use of glove-boxes and dedicated equipment. 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 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.
“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, cGMP batches for clinical trials to large-scale commercial manufacturing – commented Pietro Allegrini, R&D Director at Indena – But, the key point is that Indena has the technical skills and expertise to handle a greater range of compounds, including those with a very high toxicity.”
“We are now able to further expand Indena’s offer and provide a top-quality service to our partners, in terms of breadth of technologies , flexibility and capacity. This is of great value for our partners, to whom we offer in this way tailor-made services” – added Allegrini.
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.
