Extraction as a science

Custom development and manufacturing has traditionally been part of Indena’s strategy and offering. Find out more at stand 6B51

Indena typically treats other companies as partners, rather than customers, as most of its APIs are tailor-made to fit specific needs. Extraction, probably the oldest known process used to access active ingredients and the core technology involved in the production of many healthcare ingredients, has, for Indena, become the science of supplying high quality ingredients with the best cost-quality ratio. All this is done using fully equipped phytochemistry labs, pilot plants, analytical labs, industrial plants, isolation and purification/drying, and finishing equipment. These efforts and commitment in research and innovation lead Indena to obtain remarkable results, responding to increased requests from the markets and to the new global challenges.

From grams to tons, Indena is the ideal partner

Early in 2018 Indena opened a new kilolab dedicated to HPAPIs (natural, fermentation, semisynthetic, total synthetic), which capitalises on its long lasting experience in the area of high containment. The company is now able to offer customised solutions for projects on complex molecules, with particular focus on the supply of APIs and APIs Intermediates, Highly Potent APIs, pharmaceutical extracts, as well as food supplement and personal care ingredients. All this from small-scale clinical supplies to large commercial batches (from grams to tons), in a full cGMP compliant environment and US-FDA inspected facilities.

The new kilolab is designed to handle the production of toxic substances requiring an Occupational Exposure Limit (OEL) of 20ng/m 3 : it implements the best available security procedures for people working in the lab and it deploys the best and most innovative technologies for containment preventing the accidental release of HAPI-materials outside the containment areas, including the use of glove-boxes and dedicated equipment. This level of confinement also allows for handling toxins, such as maytansine derivatives, which can be used by ADC manufacturers.

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 that owns the highest levels of safety. The lab is able to perform full synthesis and HPAIs contract manufacturing services, including a full range of high- power manufacturing capabilities such as extraction, isolation, purification and synthetic modifications for active pharmaceutical ingredients on a wide range of scales.

The new kilo-lab is being followed by the building of a new multi-purpose pilot plant, designed for grinding, extraction, purification of toxic plants and equipped with columns for chromatographic purification, synthesis equipment, replicating in one place all the technologies available at Indena. Furthermore, Indena, that has been utilising large scale spray drying for over twenty years, is in the process of installing an intermediate scale spray dryer able to deal with organic solvents and excipients.

Building on its long experience and partnership tradition with client companies, Indena aims to systematically tap into opportunities complementary to its expertise, such as high containment fermentation and synthesis of difficult molecules. Projects already underway are at different stages of development, from early stages to large-scale industrial production. The investment is also Indena’s reply to market demand for Contract Development and Manufacturing services and 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.

Traceability and authenticity first

Quality for Indena is the commitment shown daily for almost a century to"design" and develop high-end botanical extracts, applying the same strictness required to work with pharmaceuticals to the production of extracts for nutrition and personal care. This means investment in research and development, highly qualified personnel, collaboration with scientists and professionals all over the world, if the company is to be always ahead of the game and second to none in innovation.

In recent years, the topic of potentially mislabelled botanical products has raised a debate at worldwide level about quality and safety and has led to concerns in general consumer confidence, especially with regards to dietary supplements. Authenticity is thus gaining a full-rounded value, strengthening the concepts of traceability and of the overall Quality. At the same time, traceability, which has always been a key element mainly for conscious manufacturers, is becoming essential also for the consumers.

The fundamentals in quality control of botanical preparations imply to ensure the accurate identification of the plants to be used. Traceability and authenticity are key elements to support the consistency of the phytochemical composition of the herbs, since a consistent physiological activity of the herbs and their derivatives depends on the consistency of the composition of their constituents, that are affected by several factors through the route starting from the genus and species of the plant to storage and transportation. When consumers use a product, they should be able to do so safely, being sure that what is reported on the label is true in terms of raw materials used, safety profile of the extract used, and quantity of active principle contained in any single dose.

Indena and Hyris are developing methods for genomic identification of botanical species based on unique sets of reagents for specific DNA sequences, called bKITs. These are part of the bCUBE technology, which finally allows full genetic analysis of biological samples in any setting. Among other purposes, the bKITs can be used within the bCUBE device to detect pathogens in a biological sample and to correctly identify the nature of the sample. Such bKITs are available for several plant species.

One of the latest examples of adulteration concerns the extracts of Saw palmetto (Serenoa repens, SP), the most expensive oil source of the pharmaceutical and healthfood market and consists of their replacement, or dilution, with cheaper substances. How difficult is to detect adulterations? What are the most interesting perspectives in fighting these dangerous practices?

Professor Giovanni Appendino will shed some light on this topics during the presentation “Champagne taste for beer price? Metabolomic and isotopic fingerprint of commercial Saw Palmetto (Serenoa repens) extracts” on October 10 th , at 11:50-12:20 at Pharma Insight Briefings, Hall 9, Stand 9C80.

Indena is the 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. Backed up by almost a century of botanical experience, the company holds more than 120 primary patents, has published more than 700 scientific studies and co-operates with the world’s most prestigious universities and private research institutions. Indena employs about 800 staff, investing around 10% of its annual turnover in research, making this activity the key to its success. Headquartered in Milan, Indena has 5 production sites and 5 international branches throughout the world and manages sales in more than 80 countries. The Company's 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.

Today, Indena supplies also capacity and expertise for custom manufacturing services and related key technologies. In particular, the company expands its offering with a new kilolab to handle semisynthetic and total synthetic APIs that require high containment (OEL of 20 ng/ m 3 ).

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