Indena, the leading company dedicated to the identification, development and production of high quality active principles derived from plants, has developed over the years an important expertise in handling molecules requiring high containment. The company capitalized its experience in this field by implementing state of the art high containment solution for high potent NCE manufacturing, embedding also   molecules obtained via Synthesis or fermentation processes. That’s why, through its Custom Development & Manufacturing Organization services, Indena is the ideal partner for biotech and mid/big size pharma companies in these innovative technologies.

What we learned from Nature: Indena first Custom development experience dates back in 1990s and it was related to the first oncological blockbuster drug, Paclitaxel: the challenge included the development of a sustainable supply chain for the ingredient, the development of a method of insulation under high-containment conditions and the analytical methodology of control according to stringent pharmaceutical protocols in terms of purity and stability.

During the development phase, the drug was extracted from the bark of Pacific Yew Tree in a way that was not sustainable. To make the drug available on commercial scale, the first challenge Indena had to face was to build a robust supply chain for the biomass, and this meant developing its own Yew Tree cultivations. The second challenge was related to the development of a strong industrial method to extract and purify the intermediate 10-Deacetylbaccatin III.  The third problem was the development of a robust and clean analytical frame for the project, complying with the most stringent regulations for pharmaceutical products. Moreover, Indena had also to develop its own synthetic methods to convert the intermediate 10-Deacetylbaccatin III into the final API. The solution devised by Indena for Paclitaxel was an extraordinary result, and it has created a totally unique expertise: this experience of working with Nature, has taught Indena to manage complex molecules of any origin, from both the analytical and the production perspectives.

Custom services have been a company focus ever since and, thanks to work done over the last 20 years, nowadays those represent one of the Indena’s key strengths.

Indena manufactures 12 commercial HPAPIs from different origin: synthetic, semi-synthetic and fermentation molecules

This positioning has been achieved thanks to Indena capacity to handle HPAPI with an OEL from 1 Microgram /m3 to 0,02 Microgram /m3; the onsite availability of complementary technologies such as GMP microbial fermentation/biotransformation, synthesis and extraction capabilities and its qualified and cohesive CDMO team. These are Indena’s major technological pillars securing customized solutions to our partners.

A cornerstone of Indena is the commitment in sustainability and business continuity. Indena has always been oriented to reducing fossil fuel consumption and use, saving energy and achieving high levels of energy self-production.

By the end of 2023, 67% of the energy used by Indena will be self-produced, of which almost 23% from renewable sources.

5,177 Tons of CO2 will be saved. All of Indena’s European factories are certified according to ISO 14001 Environmental Management System and ISO 45001 Occupational Health and Safety Management System.