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CDMO SERVICE
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CDMO SERVICE
THE FORMULA FOR YOUR SUCCESS
With more than 100 years of pharmaceutical excellence and a cutting-edge vision of the future, Indena stands as the most reliable partner to design customized solutions for the development and manufacturing of natural derivatives and complex synthetic molecules.
Research and curiosity, technology and development, mastery and human genius and obsession for excellence: these are the key factors in Indena’s CDMO activity – and successful partnerships.
MEET INDENA
GAIN A PARTNER
The expertise of our R&D team, covering analytical and process development, guarantees the kind of support and results only an expert partner with a strong foundation in science can provide.
As a privately owned company with a solid financial position, Indena has the vision and the capability to adopt new technologies, capitalizing on decades of know-how in the field of complex molecules. Our long-term strategy and vision have established us as a prominent and highly reliable supplier for CDMO services.
Research & Development
A LEADING CDMO AT YOUR SIDE
Since 1921, Indena has offered custom development and manufacturing solutions, continuously expanding its range of high-quality services for the benefit of its partners.
We recently opened new suites for HPAPIs and APIs, to guarantee enhanced flexibility while retaining the highest quality standards. We can put a dedicated CDMO division, supported by a strong R&D team, at our partners’ service, and promptly implement custom solutions for specific projects requiring dedicated equipment.
READY FOR THE GROWING HPAPI MARKET
The increasing number of oncology NCEs and antibody-drug conjugates, coupled with a growing focus on personalized medicine, is shaping the demand for CDMO services. The HPAPI market is undergoing a shift towards NCEs characterized by higher potency, growing molecular diversity and segmentation for specific populations.
Unlike newcomers in the field, Indena can count on an extensive know-how in safely handling HPAPIs, complemented by state-of-the-art equipment and installations. Within its long-term strategy, Indena has kept ahead of the curve by timely investing in specialized containment facilities that guarantee both employees and the external environment are safe from exposure, capitalizing on more than 30 years of know-how in high containment.
Technology & Know-how
OUR DOUBLE COMMITMENT: TECHNOLOGY AND KNOW-HOW
In an ever-evolving context in which even the definition for HPAPI is not universally accepted, contract manufacturers are required to invest in new facilities designed specifically for this type of substances.
At Indena, we are proud to have developed and adopted technological offer, staying abreast of market needs. Furthermore, our extensive know-how in HPAPI handling effectively supports CDMO activities.
THE EXPERTISE TO ASSESS RISK
The lower the OEL, the more potent the substance – and the greater the need for rigorous containment. But manufacturers don’t always have the data to even classify a substance as a HPAPI, especially in early-stage NCEs, and therefore must adopt a conservative approach to prioritize safety.
Over the last few years, Indena has focused on innovative molecules gaining strong expertise in HPAPIs requiring high-level containment, obtained by synthesis, fermentation or from natural origin.
Currently, Indena is equipped to handle substances with an OEL of 20 ng/m3 and above, including toxin-based payloads for ADCs.
SPECIALIZED AND VERSATILE, ALL ON ONE SITE
On top of our focus on HPAPIs, we have leading expertise in the pre-formulation of poorly soluble APIs. Our combination of multiple, highly specialized technologies in one site allows us to optimize the supply chain: for example, we are able to carry out the synthesis of an API and the subsequent spray drying step using organic solvents, also in the presence of excipients to obtain a pre-formulated drug product. Indena is equipped with development- and commercial-scale spray dryers to provide clinical and commercial volumes. These activities are fully supported by our analytical team. In addition to spray drying, we have proprietary technologies to obtain solid amorphous dispersion (such as PhytosomeTM) available.
Indena has recently opened a multipurpose pilot GMP plant for productions of clinical and commercial small-scale; we are also currently implementing additional synthetic capacity, to anticipate future market demand.
In the past few years, Indena has upgraded its fermentation capacity, in a multipurpose plant that can also handle toxic compounds. Currently, the plant is equipped with 100-, 1,000- and 20,000-liter fermenters. A dedicated biotech team now supports development and scale-up activities, assisting the technology transfer to production.
OUR COMMITMENT TO YOU
As a CDMO we see ourselves as strategic partners, going beyond the mere client/supplier relationship with full commitment to developing new HPAPIs and APIs, from early clinical stages to commercial-scale manufacturing.
To always meet and surpass our clients’ expectations, Indena continues to invest, every year, in innovative technologies and services. The quality and efficiency of our equipment and facilities, however, are only half the story.
At Indena, we know that highly qualified, motivated and trained technical staff, supported by a corporate culture that is strongly oriented to quality and rigorous HSE policies, is essential to ensure that operations run safely, seamlessly and efficiently.
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Documents
Whitepaper Pharma
PDF - 1.16 MB
White paper CDMO
PDF - 1.02 MB
Few examples recently developed:
Mimicking nature – and bringing it up to industrial scale.
After an innovative biotech company identified and studied a molecule derived from a rainforest plant that animals systematically avoided, a novel anticancer lead was discovered. Indena brought in its expertise and technological capacity to optimize, scale up and validate the industrial process to produce this naturally derived NCE, guaranteeing a widespread therapeutic use.
A new API to treat hematologic malignancies.
A REPURPOSED API TO TREAT HEMATOLOGIC MALIGNANCIES AND SUPPORT STEM CELL TRANSPLANTATION
Leveraging research capabilities, technical infrastructure and our team’s specialized know-how, Indena joined forces with one of its outstanding partners to redesign the synthesis of a repurposed, totally synthetic API that helps fight cancers affecting the production and function of blood cells. The project allowed us to develop and validate a robust process and to provide a sustainable supply of this highly potent API.
Constantly innovating the HPAPI market.
Recently, Indena successfully developed the manufacturing process of a non-opiate, naturally derived NCE for the treatment of severe pain, establishing and consolidating at the same time the supply chain of a unique biomass. Thanks to our expertise and dedicated facilities, the compound is now available to support late-stage clinical trials and commercial launch phases.
