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INDENA’S NEW KILOLAB: THE SCIENCE OF TAILOR-MADE HIGH CONTAINMENT

Milan, March 6th, 2018Indena has 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.

Kilolab2018

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 manufacturingcommented 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.

Indena is the leading company dedicated to the identification, development and production of high quality active principles derived from plants, for use in the pharmaceutical, health food and personal care industries. Backed up by over 90 years of botanical experience, the company holds more than 120 primary patents, has published more than 700 scientific studies and co-operates with the world’s most prestigious universities and private research institutions. Indena employs about 800 staff, investing around 10% of its annual turnover in research, making this activity the key to its success. Headquartered in Milan, Indena has 5 production sites and 5 international branches throughout the world and manages sales in more than 70 countries. The Company’s experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMA, FDA and ESCOP, and cooperate on the update of all the main pharmacopoeias.

Today, Indena supplies also capacity and expertise for custom manufacturing services and related key technologies. In particular, the company expands its offering with a new kilolab to handle semisynthetic and total synthetic APIs that require high containment (OEL of 20 ng/m3).



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