Indena
Laying the Groundwork for Pharma Innovations

The year 2021 marks the 100th anniversary of Italian pharma tech giant, Indena, which has firmly established itself as a global leader in the identification, development, and production of active principles derived from plants, for use in the pharmaceutical, health food and personal care industries. While its historical presence lies in the botanical derivatives space, Indena has made huge technological strides and further strengthened its expertise in CDMO services for active pharmaceutical ingredients (APIs) and highly potent APIs (HPAPIs) either from synthetic, fermentation and natural origin.

It wasn’t until 30 years ago when the family-owned enterprise added a feather to its cap by structuring itself as a Contract Manufacturing and Development Organization (CDMO/ CMO). As revealed by Stefano Togni, business development director at Indena, the Italian company’s first HPAPI CMO project involved the mass manufacturing and supply of a taxane, the active ingredient in a host of chemotherapy drugs used to treat various types of cancer. “At the time we were working with the originator of this taxane, which was the first oncology/API drug due to become a blockbuster in the global market. We stepped in and built a robust supply chain adopting a semisynthetic approach from renewable sources, since this HPAPI was facing supply issues from the natural source. This was a very successful CDMO project at a time when it was not even called CDMO,” says Togni. Since then, Indena has emerged as one of the world’s largest suppliers of anti-cancer natural and semisynthetic APIs.

In many cases, like the aforementioned taxane success story, innovators in life sciences approach Indena with the idea to outsource the further development and commercial supply of an API requiring specialized technologies. This is the case, for example, of HPAPIs requiring fermentation, downstream and semisynthetic modifications in high containment, which is carried out through the use of proper equipment and proper skills for the treatment in glove-boxes needed to suitably handle a highly-potent compound.

This is where Indena steps in. “The biggest pain point in the industry we try to solve is the difficulty in the supply chain plus the barriers that are represented by the need to combine different manufacturing technologies and expertise.

We are able to provide the pharma-specific environment to carry out these activities and have now extended our offer to fermentation and total synthetic difficult APIs and HPAPIs with an OEL of 20 ng/m3,” explains Togni, before highlighting another example of a partner developing an experimental NCE meant to serve as a pain-killer. In trying to solve their biomass supply chain predicament, Indena developed a semisynthetic approach and allowed the client to reach the market with increasing volumes of the API.

The biggest pain point in the industry we try to solve is the difficulty in the supply chain plus the barriers that are represented by the need to combine different manufacturing technologies and expertise

Another visible trend in the industry that Indena is determined to serve is the need for spray drying from organic solvents and in the presence of excipients, since more and more NCEs under development are endowed with a poor solubility. Indena boasts of both midscale and large scale spray drying capacity for organic solvents and plans to expand its resources in this area for HPAPIs with an OEL > 1 mcg/m3.

By banking on its ninety-plus years of expertise on extracts, pure isolated molecules, semi-synthesis from natural scaffolds, fermentation of toxic compounds and a state-of-the-art manufacturing site that meets all US FDA, ICH, and EU requirements, Indena continues to expand its CDMO service business. According to Togni, Indena typically works with innovator companies, either large scale corporations or small start-ups with the same level of dedication and attention.

Indena is currently expanding its portfolio of services by improving the flexibility of its multi-purpose fermentation department and launching a brand new pilot pharmaceutical plant, to efficiently serve new clinical developments and commercial projects requiring productions in the range of hundreds of kg supply. “A logical next step for us is to serve the ADCs market; as a matter of facts we are already accumulating experience in the manufacturing of payloads, given the currently available technologies suitable for the handling of toxins,” concludes Togni.