Bright Minds Make Things Happen
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RESEARCH & DEVELOPMENT
Bright Minds Make Things Happen
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The Statement
The R&D department is Indena’s internal think tank dedicated to phytochemical engineering as a means to explore how humankind, in the next few decades, might take care of its health by reconnecting with the natural world.
Nature offers us boundless inspiration for brilliant ideas. There is no limit to what we can achieve when research begins with better, smarter cooperation with Nature itself, in a never-ending story of quality.
With this shared belief, our scientists put their heads together, synchronizing human capabilities, combining their intuition and know-how, multiplying wisdom to overcome the manifold problems in people’s health.
Indena e lo sviluppo di una filiera sostenibile per farmaci di origine naturale
Il Ministero dello Sviluppo Economico, nell'ambito del Fondo per la Crescita Sostenibile - Accordi per l'innovazione " Scienze della vita", di cui al D.M. 5 marzo 2018, ha stipulato un Accordo con Indena SpA (capofila) per il finanziamento del progetto “Sviluppo di una filiera sostenibile per farmaci di origine naturale (FARM.ON - F/180009/01-02/X43)” da realizzare insieme a Procos SpA. nelle proprie unità produttive site nei territori della Regione Lombardia e Piemonte, per un importo previsto di € 12.045.900,00, ed ammesso di € 9.634.256,10 di cui € 7.792.573,48 di Indena SpA (capofila) e € 1.841.682,62 di Procos SpA (coproponente).
La Regione Lombardia contribuiscono per il 3% del finanziamento ammesso.
Il progetto FARM.ON ha l'obiettivo di disegnare e implementare filiere innovative e sostenibili per farmaci semisintetici antitumorali altamente potenti di derivazione botanica e fermentativa.
FARM.ON ha la finalità di rendere maggiormente disponibili agli utenti finali farmaci di alto valore terapeutico ad oggi poco accessibili o a rischio di disponibilità.
The Italian Ministry for Economic Development, within the Italian Fund for the Sustainable Growth - Agreements for Innovation "Life Sciences", as per Ministerial Decree dated March 5th 2018, has signed an Agreement with Indena SpA (leader) for the funding of the project "Development of a sustainable supply chain of drugs of botanical origin (FARM.ON - F/180009/01-02/X43)" to be realized with Procos SpA in their own facilities based in Lombardia and Piemonte Regions, for a total projected cost of € 12.045.900,00 and a total authorized budget of € 9.634.256,10 of which € 7.792.573,48 by Indena SpA (leader) and € 1.841.682,62 by Procos SpA (coproponent).
Lombardia Region contributes for a quote of 3% of the eligible costs.
FARMON project's scope is the design and the implementation of innovative and sustainable supply-chains for high potent hemisyntehtic anti-cancer drugs of botanical or fermentative origin.
The ultimate goal of FARM.ON is to make life-saving drugs accessible to patients, especially when their supply is at risk of availability or sustainability.
Process R&D Unit
Product R&D Unit
Pharmaceutical Innovation Unit
Approach
Our approach.
Process Research Unit And A Deeper Concept Of Natural Product
Natural products have been completely redefined in the last decades.
Today, the category is often thought to include any product of organic origin, whether for food or cosmetic use, regardless of the fundamental role any substance taken from Nature has played, or is playing, in a drug’s discovery process and applications.
At Indena, however, we know that only by carefully studying biological activity and underlying molecular mechanisms we can identify unprecedented principles, pathways and targets that can turn out to be highly relevant for human health.
Our context.
Nature-Inspired Drug Discovery
Aspirin, morphine, penicillin: perhaps the most famous drugs of natural origin.
Natural products can either be directly used to treat human diseases, or serve as a valuable lead for discovery programs – as happened with statins, phlorizin and sphingosine analogs.
Indeed, about 30% of approved small-molecule drugs in the world today derive from natural products, and another 30% were designed by mimicking natural substances.
(D.J. Newman and G.M. Cragg, J. Nat. Prod. 2016, 79, 629−661)
And while Nature provides us with a variety of different sources – from marine life to microbes – pharmacopoeias around the world show medicinal plants prevail in cardiology, neurology (especially for the central nervous system) and oncology.
A blaze of glory
The Anti-Cancer Potential Of Nature
Natural products have brought more benefits to oncology than to any other therapeutic area.
The disruptive discovery of molecules like vinblastine, vincristine, camptothecin and paclitaxel in the 1960s and 1970s completely revolutionized the approach to cancer treatment, introducing chemotherapy as an alternative to radiotherapy and surgery.
As a leader in natural product chemistry and in the production of paclitaxel in particular, Indena was always part of the dream to cure cancer.
This dream was the beginning of our studies in medicinal chemistry, and still inspires our efforts to optimize natural leads and enhance natural products.
Our pathway to health
Product Research Unit: From Science-Based Ideas To Practice
The Product Research Unit was established upon Indena’s foundation, with highly qualified R&D resources entrusted with the mission to design and develop new, premium botanical ingredients for health and nutrition.
At Indena, every new product begins with an idea and an initial feasibility evaluation that encompasses biomass availability, regulatory assessment and potential market demand.
If the idea passes this first test, the Product Research Unit starts the research phase in close collaboration with the Process Research and Analytical Departments, and later the Formulation Development Laboratory.
Thanks to this coordinated, multi-disciplinary research approach, Indena is able to successfully offer innovative solutions in the botanical complex market – with a proven track record of approximately 100 patent families.
Throughout the process, our commitment is to turn science-based ideas into practical solutions for people’s health and wellbeing.
R&D in numbers
Percentage of Revenue Dedicated to R&D
Human studies on our supplements: 100+
Our research team: 73 people
(5 on Product Research, 5 on Formulation Development, 40 on Process Research and 22 on Analytical Research)
2017
4.7%
2018
5.3%
2019
5.5%
2017-2019
5.2%
On the cutting edge of phytochemical solutions
Quality At Every Step Of Innovation
At Indena, quality begins with the first prototype sample and is never left behind.
In developing our premium ingredients, the phytochemists in our Process Research Department constantly apply strict quality standards according to applicable regulations, in order to preserve plants’ natural complexity.
Every step is monitored and tracked, contributing to each sample’s analytical certificate.
This provides the Product Research Unit with the information they need to explore the sample’s benefits through scientific and human studies.
Formulation
The Importance Of Formulation
Formulation is crucial for bioavailability
Botanical ingredients formulated with poor water solubility offer limited intestinal absorption, hindering any potential health benefits they may have.
At Indena, we apply dietary-inspired delivery technologies to high-quality nutraceuticals, designing optimal solutions in terms of effectiveness and costs thanks to the strong collaboration between our Product Research Unit and Formulation Development Laboratory.
SCROLL DOWN TO FIND OUT MORE ABOUT INDENA PHYTOSOME™ DELIVERY SYSTEM.
Human Substantiation and Scientific Collaborations
With consumers’ growing awareness and attention for quality, it is more important than ever for us to invest in scientific research and support the botanical extracts we market with consistent scientific and human evidence.
With high quality as a de facto market requirement, the scientific literature supporting a specific botanical extract can really make the difference.
Indena has always upheld this serious scientific approach, and so has always had a full portfolio of products that are not only safe and effective, but also scientifically documented with proprietary studies.
We never settle on generic botanical literature or “borrow” science from others: we trust our own, and rely on ingredient-specific biomedical data.
In order to perform human studies on health food ingredients, we have developed a collaboration network with hospitals, universities and research centers worldwide.
Each human outline and protocol is designed following the existing guidelines for contribution and maintainance of beneficial effects and according to the structure-function models. The outline is thoroughly discussed and devised with clinicians in order to fulfil the real unmet needs for consumers.
Indena constantly collaborates with scientific institutions also to refine and curate analytic methods and even to devise new ones.
Among others:
Member of European Pharmacopaea's PST Working Party (pesticides in herbal drugs)
Italian representative in the organic chemistry and phytochemistry Working Party EXT for definition of various monographs for both natural or semisynthetic pure products or botanical extracts and drugs
Platinum Level Donor in the USP/NF program Monograph and Reference Material Donor
The Importance of Mechanism Of Action
Botanical extracts are a unique source of active principles that maintain physiological homeostasis, each one modulating different cellular pathways.
It’s our mission to explore and discover the main biological targets of each “premium” ingredient in order to rationally support the human research and offer to the market ingredients endowed with a proprietary documentation for any desired health indication.
For the mechanism of action, studies on enzymes are carried on in our own R&D laboratories, while for the extension to cellular systems we actively interact with external groups specialized in the most-up-to date receptors or cells pathways.
INDENA PHYTOSOME™
DISCOVER INDENA PHYTOSOME™
ENHANCING
THE POWER OF PHYTONUTRIENTS
Take on a key role in the emerging prevention model to contrast and delay the onset of various health conditions and access phytonutrients’ endless benefits with Indena Phytosome™, Indena’s Technology Platform to make natural compounds more effective. To improve people’s health.
TRUST INDENA PHYTOSOME™Collaboration model
Our collaboration model
DEEP TIES BETWEEN R&D AND CDMO
Complexity in organic chemistry has been part of our expertise since the company’s foundation, about one century ago. Natural products in general, and those obtained from plants in particular, are characterized by unique structures with a variety of biological effects.
Even though they are natural entities, some of them are potent medicines, with a critical toxicological behavior.
Dealing with natural products for many years has taught us to manage the extraction, concentration and synthesis of delicate and complex molecular entities, requiring deep analytical expertise to investigate their structure and purity.
In addition, our research team has had to familiarize with synthetic or extraction processes to obtain toxic products, and with managing them properly from the health and safety standpoint.
For this reason, we have built great expertise in the management of highly potent APIs, with an Occupational Exposure Limit (OEL) of up to 20 ng/m3.
Our state-of-the-art glove boxes are used in such developments even for the R&D activity.
The heritage of natural products is also related to a deep knowledge in the development and scale-up of chromatographic purifications, performed in a wide size range of (from mg to hundreds of Kg) using complementary technologies (direct and reverse phase chromatography, ion exchange and absorption). Sometimes, a complex extract obtained from a vegetal biomass is itself the active ingredient. In this case, the traditional single molecule analytical approach is not suitable to define the critical quality attributes of the drug substance, while orthogonal analytical methods combined with chemometrics is the right tool.
How our services empower your business
EXPERT PARTNERS = GREAT SCIENCE
Process research
Our experienced team of 40 can tackle every step from process research activities – finding the most appropriate synthetic approach or identifying the right natural source to produce an active ingredient – to process development and scale-up.
For projects based on natural biomasses, a botanical research group supports our purchasing department in the definition of a sustainable supply chain,
including the collection of wild plants according to SuSo (Sustainable Sourcing) principles, domestication and cultivation of selected varieties, and agricultural programs to enhance active ingredient content.
The team collaborates with a biotechnology lab for the genetic identification of natural sources as well as for the development of fermentation processes
to produce active pharmaceutical ingredients or advanced intermediates.
Analytical research
Our CDMO activities are entrusted to a team of 22 scientists supported by state-of-the-art analytical equipment, who develop and validate appropriate analytical methods for all process, release and product stability requirements.
The team applies GMP quality standards to the release of clinical and process validation batches as well as throughout the analytical development, taking into account data integrity compliance since the very beginning.
At Indena, analytical research is carried out at the highest scientific level, in order to properly manage and maintain the critical quality attributes that allow molecular structures and mixtures to closely resemble the complexity of biological ingredients.
Our internal team also covers physical-chemical aspects of the product such as crystallinity, the shape and size of particles and polymorphism.
To do all of this, we use a wide range of analytical techniques and skills, including: 400MHz and 60MHz NMR; 18 HPLC and 8 UPLC, with UV, DAD, ELSD, CAD, RI, MALLS detection; single and triple quadrupole mass spectrometers,
plus two ion-traps with high resolution; 5 GC-FID plus single quadrupole MS detector;
capillary electrophoresis; TGA, DT/TGA, DSC, DSC/TGA, HSM, DVS, XRPD, FTIR, NIRS;
and wet- and dry-cell particle size analyzer.
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CDMO Service
We do believe health is a joint project. With 100 years of experience, we bring an intelligent approach crucial to innovating solutions.
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We believe that quality must be for everyone and it's a constant inclination. We make efforts to dissect, analyze and evolve our quality system, ensuring even more fairness in the system itself.
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