Indena increases bespoke manufacturing capacity for HPAPIs

The Italian company has opened a kilolab at its facility in Settala

Indena, the Italian manufacturer and containment specialist, has opened a kilolab in Settala, Italy, to expand production of natural, semi-synthetic and totally synthetic highly potent active pharmaceutical ingredients (HPAPIs).

In the new kilolab, Indena has successfully made the first totally synthetic HPAPI.

The new kilolab is designed to handle the production of toxic substances characterised by an occupational exposure limit (OEL) of 20 ng/m3. The expansion allows the company to capitalise on its long-standing high containment experience.

Indena commented that this level of confinement will also allow for handling toxins, such as maytansine derivatives, which can be used for antibody-drug-conjugate manufacturing.

The laboratory has been designed to perform full synthesis and HPAPIs contract development, as well as manufacturing services, including extraction, isolation, purification and synthetic modifications for APIs on a wide range of scales.

According to Indena the facility utilises the best available security procedures for people working in the lab. It also deploys the best and most innovative technologies for containment to prevent accidental release of HPAPIs outside the containment areas, including the use of glove-boxes and dedicated equipment.

“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,” 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, as we can thus offer tailor-made services,” added Allegrini.

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 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 specialises in the identification, development and production of high quality active principles derived from plants, for use in the pharmaceutical, health food and personal care industries.