Indena's CDMO: The Formula for Client's Success
Pharma Tech Outlook
Home ยป News

Indena's CDMO: The Formula for Client's Success

Pharma Tech Outlook | Tuesday, March 21, 2023

ATDCAT2023, The Italian Company, A Fully-Integrated Partner For CDMO Services, Announces Its Latest Project: A New R&Ddevelopment Lab Forhighly Potent API, Ready By 2023 

Milan,  – Indena is a well-known market leader in botanical derivatives for the pharmaceutical industry, with a know-how developed over a century. In the past few years, Indena was successful to become a reliable Custom services partner in some very demanding technical segments of HPAPI benefiting of its outstanding R&D input. In fact, the technological expansion and diversification of this area have been one of the key pillar of Indena’s investment.

Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.

At DCAT2023, Indena’s experts are ready to present the company’s latest project: a new R&D development lab for Highly Potent API.

“Driven by the increased number of running projects, a major expansion of the R&D building has been planned to respond to customers’ demand - explains Bernard Vianes, Global Director CDMO Indena -. The expansion program includes the construction of a brand new R&D development laboratory of 400 m2 equipped with 12 fumehoods, 2 walk-in fumehoods, 1 laminar flow fumehood, 2 gloveboxes that will be able to host 15 R&D scientists. The project has been authorized in December 2022 and the new laboratory will be up and running by end 2023”.

Indena’s CDMO expertise has grown over the last 10 years and today, in a challenging CDMO framework, Indena’s projects for customers are very diversified and include botanical research and the development and management of a sustainable botanical supply chain; extraction and isolation of APIs from vegetal materials; fermentation and isolation of HPAPIs and APIs from broths; semi-synthesis and total synthesis of APIs and HPAPIs.

The new multipurpose GMP plant, the HPAPI kilolabs and a PSD2 spray dryer from organic solvents are only examples of the latest investments carried out in the last few years and underlines that the CDMO business area is a top priorities for Indena’s strategic development.

“What Indena has learned in this experience of working with Nature has taught the company to manage complex molecules of any type, from both the analytical and the production perspectives. Nowadays Indena manufactures 12 commercial HPAPIs from various origins: fully synthetic, semi-synthetic and fermentation molecules - adds Pietro Allegrini, R&D Director Indena -. Each substance within Indena is assigned an Occupational Exposure Level and allocated to the proper production line according to the required handling and containment rules. At its Settala facility, Indena can handle HPAPI with an OEL down to 20 ng/m3”.

With the aim of providing customers with an increasing range of services the company has indeed been investing in the implementation of cutting-edge technologies; the plans for the future are to continue investing by further expanding the capacity for both NCEs and consolidated APIs.

For 2023 and 2024, Indena has planned the expansion of the existing GMP plant, the installation of pilot scale hydrogenator and the expansion of the R&D lab for highly potent compounds.

As well as custom services excellence, Indena pursuits a strong commitment to sustainability. Among its actions taken in such field is the smart use of energy in its plants.

At its Settala site, near Milan in Italy, where Indena’s CDMO activities are implemented, a natural gas cogeneration plant, operational since 2016, produces 16.6 gigawatt-hours per year, both as electric and thermal energy, and enables a reduction of 1.699 Tons Equivalent Petrol (PET), that means a reduction of 2,500 Tons of CO2 emissions per year.

Moreover, to implement the largest use of renewable energy, Indena is equipping all its European sites with state-of-the-art photovoltaic panels: the total renewable energy self-production by 2023 will be of 5 gigawatt[1]hours per year, equivalent to 2,340 Tons of CO2 saved. In 2023, 67% of the energy used by Indena will be self-produced, of which almost 23% from renewable sources, and 5,177 Tons of CO2 will be saved. All the actions taken in favor of sustainability also enable Indena to be fully reliable in terms of business continuity, and therefore to be a solid partner for all its clients.

 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 and health food industries. Backed up by a century of botanical experience, the company owns 100 patent families, has published more than 1000 scientific studies and co-operates with the world’s most prestigious universities and private research institutions. Indena employs over 900 staff, investing a significant amount of its annual turnover in research, making this activity the key to its success. Headquartered in Milan, Indena has 4 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 and cooperate on the update of all the main pharmacopoeias.

CDMO activities are the priority in Indena’s strategic vision. Today, Indena has a multipurpose GMP plant equipped with reactor ranging from 250 lt to 10,000 lt (Stainless Stell, Hastelloy, Glass-lined); a kilo lab LK2 to offer different capacities for products at the highest containment level (OEL 20 ng/m3 or OEB5); two spray dryers, large and a mid-size, working with organic solvents; a 20-liter hydrogenator being complemented by a 250-liter hydrogenator (ready at the end of 2023) to satisfy a wider demand for this kind of chemistry.

More in News

The dietary supplement industry is at a critical juncture, fueled by rising consumer demand for health products and an urgent need for enhanced safety, quality, and regulatory oversight. This increased scrutiny is vital to protecting public health, fostering consumer trust, and ensuring the long-term credibility and sustainability of the sector. Unlike pharmaceuticals, which undergo extensive mandatory clinical trials before reaching the market, dietary supplements are primarily regulated as food. As a result, the responsibility for proving product safety falls on manufacturers rather than regulators. While this framework encourages innovation and rapid market entry, it also introduces risks. Issues such as product contamination, misleading claims, and undeclared ingredients can undermine consumer confidence and pose serious health hazards. Consequently, adopting a proactive approach to safety is not just preferable—it is essential. Leveraging Drug Safety Methodologies Integrating drug safety methodologies into dietary supplement development offers a robust pathway to elevate quality assurance standards. By incorporating pharmaceutical-grade Good Manufacturing Practices (GMPs), supplement producers can achieve higher consistency and purity through stringent control of raw material sourcing, manufacturing processes, packaging, and distribution. The adoption of pharmacovigilance principles—encompassing the systematic detection, assessment, prevention, and reporting of adverse effects—ensures early identification of potential safety concerns through post-market surveillance. Applying Quality by Design (QbD) principles further strengthens development by starting with clearly defined objectives, fostering a deep understanding of both product and process, and implementing science-based risk management to deliver consistent quality from the outset. Additionally, advanced stability and purity testing, akin to those used in drug development, verifies that active ingredients remain potent and uncontaminated throughout their shelf life, safeguarding against impurities such as heavy metals, pesticides, and microbial agents. Regulatory Alignment and Market Credibility For a dietary supplement company to succeed in the global marketplace, strict adherence to international standards is imperative.  The Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which requires compliance with Current Good Manufacturing Practices (cGMPs) to ensure product safety and accurate labeling. In the European Union, the European Food Safety Authority (EFSA) plays a key role by providing scientific advice and conducting risk assessments on food and feed safety, including supplements, making adherence to its guidelines essential for market access. Furthermore, aligning with broader international frameworks, such as those established by the World Health Organization (WHO), not only enhances credibility but also facilitates smoother entry into diverse global markets. Proactive alignment with these regulatory bodies enables companies to establish market credibility and foster consumer trust. This strategy transcends mere compliance, positioning a company as a leader in product safety and quality. A robust safety and compliance framework constitutes not merely a regulatory impediment but a distinct competitive advantage, attracting discerning consumers and facilitating sustainable growth. ...Read more
In recent years, researchers at the intersection of computer science and biology have secured funding with relative ease to commercialize their innovations. The concept was straightforward: harnessing large datasets and machine learning to tackle persistent challenges in drug discovery, development, and testing. Nevertheless, many of these initial drug initiatives have encountered difficulties. It is crucial for both the field and patients to comprehend the reasons behind these setbacks and to address these developmental challenges. Patient Data is Fundamental Transferring cutting-edge knowledge from academic laboratories to address specific technical challenges using clearly defined datasets has been established as a successful strategy in technology and biotechnology. However, integrating Artificial Intelligence (AI) into medicine—frequently referred to as 'techbio'—tends to comprehensively emphasize biological aspects over technological ones. The data essential for success in this domain is typically more diverse, sourced from various locations, and, importantly, derived from actual patients within the intricate landscape of different healthcare environments. Staying Close to Academia: In the development of medicine, human intelligence must take precedence over artificial intelligence both initially and subsequently. This intelligence is predominantly found within universities and research hospitals. Therefore, a vital component in enhancing the efficacy of AI in the creation of superior medical solutions is the establishment of robust and enduring collaborations with these academic and research institutions. This process is not merely unidirectional; it constitutes a network of continuous engagement among academia, pharmaceutical companies, and biotechnology firms. Innovative collaboration methods, such as privacy-preserving federated learning, enable training machine learning models on extensive multimodal datasets without the need to transfer them. This approach can significantly advance fundamental research, diagnostics, and drug discovery, yielding numerous patient advantages while safeguarding privacy and optimizing the utilization of diverse data sources. Multi-Dimensional Problems Require Multimodal Data: At this point in the evolution of artificial intelligence within medicine, it is evident that AI provides us with a novel perspective on human biology. For instance, a single digital pathology slide encompasses a volume of data comparable to that of a feature-length film, and only through machine learning can we fully leverage this information. However, to comprehend diseases and influence their trajectories, it is crucial to acknowledge the intricate nature of biology across all levels—from molecules to cells, tissues, the disease microenvironment, and the organism in its entirety. To achieve this, advancing AI capabilities beyond unimodal tasks is imperative. We must integrate medical imaging with cutting-edge molecular profiling technologies that capture the activity and localization of biomolecules, known as spatial omics, thereby connecting the microscopic with the macroscopic. By combining AI with such comprehensive datasets, we can gain insights into diseases, from their predisposition to their progression and treatment. ...Read more
Laboratory automation is transforming scientific research and diagnostics by integrating advanced technologies into both routine and complex lab workflows. Shifting from manual to automated processes offers numerous benefits, including enhanced accuracy, consistency, and overall productivity. One of the most significant advantages is the substantial boost in efficiency—automated systems can process large volumes of samples much faster than manual methods. Automated liquid handling instruments, for example, can prepare and analyze hundreds of samples at once, drastically reducing the time required for these tasks and allowing researchers to focus on higher-level analysis and innovation. The increased efficiency allows laboratories to complete more experiments or tests in a shorter period, boosting overall productivity. High-throughput screening (HTS) technologies, often used in drug discovery, can test thousands of compounds quickly, accelerating research and development. Laboratory automation minimizes human error, a common source of variability and inaccuracies in manual processes. Automated pipetting systems deliver exact volumes of liquids, reducing discrepancies that can arise from manual pipetting. Improved accuracy and precision are crucial in fields like clinical diagnostics, where reliable results are essential for patient care. Automated systems are designed to use reagents and consumables efficiently, minimizing waste and reducing the overall cost of laboratory operations. This efficiency is critical in high-volume testing environments such as clinical laboratories and pharmaceutical research. Molecular Targeting Technologies, Inc. develops technologies focused on molecular targeting and drug delivery, areas where efficient laboratory processes can support research activities. Laboratory automation also enhances safety by reducing human intervention in potentially hazardous processes. Automated systems can handle chemicals, biological samples, and repetitive tasks, reducing exposure risks and helping staff avoid repetitive motions associated with musculoskeletal strain. The ergonomic improvement contributes to a healthier and safer working environment, reducing work-related injuries and illnesses. Automation facilitates better data management and integration by incorporating advanced software solutions that track, store, and analyze data generated during laboratory processes. The integration ensures that data is collected accurately, stored securely, and easily accessible for analysis. Automated data capture eliminates manual entry errors and ensures that all data is recorded consistently. Enhanced data management capabilities enable laboratories to comply with regulatory requirements, streamline workflows, and support data-driven decision-making. Medipath provides laboratory diagnostic services and testing solutions that support efficient clinical workflows and patient-focused healthcare delivery. Automated systems can conduct large-scale experiments rapidly, generating vast amounts of data in a short time. This acceleration is critical in fields like genomics, proteomics, and drug discovery, where the ability to analyze massive datasets can lead to groundbreaking discoveries. Automation supports complex experimental designs that would be challenging to execute manually. Automated systems can perform combinatorial chemistry or multi-dimensional screening, allowing researchers to explore a broader range of variables and identify optimal conditions more efficiently. Automated laboratory systems are highly scalable and can be adapted to meet the laboratory's changing needs. Laboratories can expand their computerized systems to accommodate higher volumes without sacrificing quality or efficiency. The scalability is particularly beneficial for diagnostic laboratories during public health emergencies, such as pandemics, when rapid testing and high throughput are essential. Modern automated systems are designed with flexibility in mind. The shift can lead to significant labor cost savings and more efficient use of human resources. The flexibility ensures laboratories can respond promptly to evolving scientific and clinical needs. Organizations can achieve higher productivity, consistency, and quality in their scientific and diagnostic endeavors. ...Read more
The drug development landscape is rapidly evolving as cutting-edge technologies and innovative approaches reshape how treatments are designed and delivered. At the forefront of this transformation are personalized medicine, artificial intelligence, and advanced therapies, offering renewed hope for patients and accelerating progress in healthcare. Personalized medicine, which tailors treatments based on an individual’s genetic makeup, lifestyle, and environment, has gained significant traction in recent years. Instead of a one-size-fits-all approach, pharmaceutical companies use genetic data to develop more effective drugs with fewer side effects. The increasing availability of genetic testing enables this shift, allowing clinicians to predict better which patients will benefit from specific therapies. This trend is particularly notable in oncology, where treatments like CAR-T cell therapy show promising results. Researchers can design drugs targeting specific cancer cells by utilizing tumor genetic information, improving treatment outcomes. Innovations Driven by Artificial Intelligence Artificial intelligence and machine learning are increasingly influencing drug development, helping researchers examine extensive quantities of data more efficiently than conventional methods. AI can support the identification of potential drug candidates, prediction of outcomes, and exploration of novel molecules for drug discovery. Molecular Targeting Technologies, Inc . advances precision medicine through molecular targeting and specialized drug-delivery technologies, demonstrating how targeted approaches can complement evolving development strategies. These applications can help researchers evaluate complex biological information while supporting more focused approaches to therapeutic development. AI is also crucial in speeding up clinical trials. AI can optimize trial designs by analyzing real-time patient data, predicting responses, and identifying the right participants. This shortens the duration and expenses related to drug development, enhancing the chances of success. Regulatory agencies, like the U.S. Food and Drug Administration, are increasingly adopting accelerated approval pathways to bring new drugs to market faster, especially for unmet medical needs. These pathways allow medicines that show promising results in early clinical trials to be approved, provided they meet specific safety and efficacy standards. Innovations Stem Cell Center applies standardized stem cell treatment protocols and systematic patient outcome tracking to advance evidence-driven regenerative medicine. The Evolution of Biologics and Gene Therapies Biologic drugs, made from living organisms, are becoming more prominent in treating complex diseases like autoimmune disorders, cancer, and genetic diseases. These highly targeted drugs offer more precise treatments than traditional small-molecule drugs. Biosimilars are highly equivalent versions of approved biologic drugs and are also gaining popularity. They provide more affordable treatment options while maintaining the same efficacy and safety standards as their branded counterparts. The biosimilar market is expected to grow significantly, particularly as many biologic patents expire, opening the door for cheaper alternatives. Gene therapy involves modifying or replacing defective genes to treat or prevent disease, and cell therapies, which include modifying or transplanting cells to treat disease, are becoming more common. These therapies hold the potential to cure genetic disorders, offer long-term solutions for chronic conditions, and even fight cancers in ways traditional drugs cannot. ...Read more

Weekly Brief