A new kilolab plant to develop and manufacture a wider range of molecules

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Backed up by over 90 years of botanical experience, Indena holds more than 150 primary patents, has published more than 700 scientific studies and co-operates with the world’s most prestigious universities and private research institutions

The phyto-chemical research is carried out in Indena’s own Research Center in Settala, Italy: the screening of medicinal plants for pharmacological benefits; the identification of new active principles; the development of cutting-edge extraction and purification systems for industrial applications.

A new kilolab plant

To further expand its offer and provide a top quality service to its partners (in terms of breadth of technologies, flexibility and capacity), Indena has started a major investment plant which lead to the recent opening of a new kilolab dedicated to HPAPIs (natural, semisynthetic and total synthetic), which capitalizes on the long lasting experience of Indena in the area of high containment.

«Custom development and manufacturing has traditionally been part of Indena’s strategy and offer: we typically treat other companies as partners rather than customers. – explains Pietro Allegrini, R&D Director of Indena – Thanks to the new plant, we can offer today a complete management of the supply chain, from the extraction of biomasses, to the purification and isolation of pure molecules, including semisynthesis and fermentation. Furthermore, we can develop and manufacture HPAPIs from total synthesis».

The investment was also spurred by some external factors, namely the increasing reliance of pharma companies on Western suppliers as a risk reduction strategy compared to the past, when most of the developments and productions were outsourced to Asian providers.

«The situation has changed a lot with the (still ongoing) issue of data integrity – explains Pietro Allegrini. – Based on increased requests (also for services typical of Contract Manufacturing Organizations), Indena has responded to market demand by investing  in technology and custom synthesis facilities».

High containment and security

The new kilolab design assures complete compliance with cGMP guidelines and allows chemists to handle hazardous materials in an environment characterized by the highest levels of safety. It’s designed to handle the production of toxic substances endowed with an Occupational Exposure Limit (OEL) of 20ng/m3.

«The new plant implements the best available security procedures for people working in the lab, deploying the best and most innovative technologies for containment thus preventing the accidental release of HAPIs outside the containment areas. The kilolab is equipped with glove-boxes under continuous monitoring systems – explains Pietro Allegrini –. The lab is GMP compliant and is able to manufacture natural and synthetic HPAPIs on a very diversified scale, both for clinical studies and for commercial use».

«Nowadays we are proud to say that we are able to handle products and processes from small scale GLP batches for toxicology, cGMP batches for clinical trials to large-scale commercial manufacturing – explains Pietro Allegrini – But the key point is that we have the technical skills and expertise to handle a greater range of compound classes, including compounds with a very high toxicity».

Analytical and research laboratories also form part of this new facility, so that all phases of the project, from development to production, can be managed in complete segregation.

The plant structure

The facility is divided into three suites. The ground floor hosts the so-called “killing tanks”, so that all toxic substances are made inactive inside the facility before sending them to the waste treatment areas. The first floor houses the R&D kilolab dedicated to the experimental phases needed before scale up and validation. The second floor hosts the glove-boxes dedicated to production, including glass reactors, evaporator filters and chromatographic columns and one for analytical activities. The architecture incorporates the possibility for future capacity doubling.

“Traditionally perceived by pharma companies solely as a provider of natural APIs, Indena is able to now offer fully synthetic capacity (including high containment), fermentation on mid-scale volumes (including toxic compounds). – explains Pietro Allegrini – Indena offers full confidence guaranteed by an excellent inspection history from most important regulatory bodies. Indena’s new Custom Services suites in Settala near Milan meet US-FDA, ICH and EU requirements.”

Pharmaceutical development

«We see Indena becoming a very attractive and solid partner for more than just natural substances» explains Pietro Allegrini. The kilolab is being complemented by a new pilot plant that will feature all technologies available at Indena and perform semi-synthesis. The construction of this new multipurpose pilot plant for semi-synthesis is already ongoing. A further step of the investment plan will also increase spray-drying capacity and flexibility at Indena, which has been utilizing large scale spray drying from organic solvents for over twenty years.

Indena is also focusing on the industrial production of standardized botanical derivatives of high quality, which are important ingredients of medicinal products and food supplements.

The medicinal plants come from a network of plantations that has been specially developed and managed, thanks to nearly 100 years of Indena botanical experience, in an optimal way to ensure both biodiversity and the protection of the ecosystem from uncontrolled collection. Today over 60% of the raw material used in production comes from these crops.

«Indena’s decade-long global presence in the plant extraction industry is a guarantee of its deep knowledge and understanding of the business, market trends and legal aspects. – explains Pietro Allegrini – Our experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMA, FDA and ESCOP, and cooperate on the update of all the main pharmacopoeias».

 

Indena is the Italian leading company dedicated to the identification, development and production of high quality active principles derived from plants, for use in the pharmaceutical, health food and personal care industries.

 

 

 

 

 

 

 

 

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