Indena, a Milan, Italy-headquartered contract manufacturing organization for the identification, development, and production of active pharmaceutical ingredients (APIs) derived from plants, has opened a new kilolab for highly potent active pharmaceutical ingredients (HPAPIs) (natural, semisynthetic, and total synthetic) in Settala, Italy. 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 of 20 ng/cubic meter. It implements security procedures for people working in the lab and deploys technologies for containment to prevent the accidental release of HPAPIs outside the containment areas, including the use of glove-boxes and dedicated equipment. The company says that the design of the new kilolab is compliant with cGMP guidelines, offers protection against cross-contamination, and allow chemists to handle hazardous materials in an environment with high 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 APIs on a range of scales.

Indena plans for the new kilolab to 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 with semi- and total-synthesis capabilities.

Source: Indena