In its product site in Settala, Italy, Indena is completing the new GMP Kilolab for high potency active pharmaceutical ingredients (HPAPIs), a high containment facility for the clinical and commercial production of highly toxic active ingredients
At Indena, the art of extraction, the oldest process known to access active ingredients and the core technology involved in the manufacture of many healthcare ingredients, is science, aimed at supplying high quality ingredients with the best cost-effective process, obtained through fully equipped phyto-chemistry and analytical labs, pilot and industrial plants, with isolation, purification and drying/finishing equipments.
Indena HPAPIs Custom Services include a full range of high potency manufacturing capabilities for active pharmaceutical ingredients across a wide scale range.
The combination of Indena’s expertise and top-class facilities delivers products and processes from small-scale batches for toxicology, to cGMP batches for clinical trials to larger commercial manufacturing.
Indena is the main producer of taxanes and it has been working on expanding its custom synthesis capacity.
The suite is designed to handle the production of substances requiring an occupational exposure limit (OEL) between 20 and 50 ng/ m3. This level of confinement also allows for handling toxins, such as maytansine derivatives, which can be used by ADC manufacturers.
Validation of the first API is planned for the first quarter of 2018; this will be a total synthesis of a commercial API whose production process was developed in recent months by the Indena R&D team.
The new kilolab can produce clinical or industrial batches and performs full synthesis, building on Indena’s expertise in cytotoxic and high containment. Indena will have the technical capacity to handle a greater range of compound classes, including derivatives from fermentation and total synthesis.
Analytical and research laboratories also form part of this new facility, so that all phases of the project, from development through to production and analysis can be managed in complete segregation.
The new kilolab will be followed by the building in 2018 of a new multi-purpose pilot plant, designed for grinding, extracting, purifying toxic plants and equipped with columns for chromatographic purification and semi-synthesis capabilities.
Furthermore, with its highly specialised quality assurance system and regulatory expertise, Indena meets the demands of the major regulatory agencies.