The growing friction between the US and China has serious consequences for the supplies of high-potency active pharmaceutical ingredients (HPAPIs), with pharmaceutical companies facing uncertainty around the stability of their supply chains and tariff-related risks. The complexities of sourcing HPAPIs from various regions, whether through fermentation, synthesis, or botanical extraction, have only heightened due to these global challenges.
One of the greatest challenges in HPAPI manufacturing lies in managing the stringent containment and separation systems to control operator exposure and cross-contamination. The narrow therapeutic windows and high potency also make analytical control and trace impurity profiling more demanding, requiring highly sensitive instrumentation and rigorous process validation. In addition, long lead times for raw materials, consumables, and specialised equipment introduce supply risk, especially amid global supply chain disruptions.
At the same time, the pharmaceutical industry is undergoing rapid transformation, with an accelerated demand for complex biologics and small molecules that amplify the pressure on reliable HPAPI manufacturing. Oncology is the largest use case for HPAPIs and remains the leading therapy area by global sales, forecast to reach $270bn in 2025. By 2030, biologics are forecast to generate $881bn in sales, compared with $533bn for small molecules. Ensuring safe, flexible, and resilient HPAPI manufacturing will be vital to meeting this growing demand.
Reliable partners in high-potency API manufacturing
Indena is a leading contract development and manufacturing organisation (CDMO), and has emerged as a key player in addressing these challenges. Among its four manufacturing sites, the site in Milan offers a unique advantage by combining synthesis, fermentation, and botanical extraction all under one roof, with a special focus on HPAPI production. . This company’s state-of-the-art facility is GMP-compliant and FDA inspected, allowing them to handle the full spectrum of manufacturing needs – from pre-clinical and clinical to commercial-scale production.
By consolidating these capabilities from one site in Europe, Indena provides much-needed supply chain security and efficiency. This setup addresses the complex needs of pharmaceutical innovators while eliminating the risks and delays that can arise with fragmented global production.
In addition to the company’s versatile manufacturing capabilities, Indena brings extensive expertise in HPAPI isolation and separation technologies, including high-potency chromatography. The company’s experience in high-potent containment ensures safe handling of toxic substances, protecting both workers and products. Specialised drying techniques – such as spray drying and freeze-drying – are used to preserve the stability of sensitive HPAPIs, ensuring effectiveness and safety.
A key example of Indena’s capabilities is its production of DM1 and DM4 and derivates. These are specific payloads for ADC and payloads-linker that require the simultaneous integration of fermentation, synthesis, chromatography, and lyophilisation processes, all under high-potency containment and GMP conditions. By managing these complex processes at the same site in Milan, Indena ensures greater efficiency, reduced lead-times, cost-effectiveness, and supply-chain security while supporting customers from early development through to large-scale commercial production.
The future of HPAPI manufacturing
As the pharmaceutical industry faces increasingly complex challenges in an uncertain global environment, Indena stands as a trusted partner in high-potency API manufacturing. With its ability to produce HPAPIs through multiple methods – all within a single, GMP-compliant and FDA-inspected facility in Europe – Indena offers a significant advantage in securing reliable, flexible, and cost-effective supply chains.
Looking ahead, as oncology, metabolic disorders, and novel therapies continue to drive pharmaceutical growth, demand for advanced HPAPI manufacturing will only increase. Indena’s integrated approach ensures that pharma companies can continue to meet the growing need for high-potency APIs, supporting innovation across the most dynamic and fast-growing segments of the global market.
To learn more about the range of solutions and expertise available from Indena, download the document below.
