{"id":185005,"date":"2025-11-24T13:21:10","date_gmt":"2025-11-24T11:21:10","guid":{"rendered":"https:\/\/www.ainia.com\/?p=185005"},"modified":"2026-04-02T13:18:12","modified_gmt":"2026-04-02T12:18:12","slug":"new-market-needs-in-european-formulation-of-api-pharmaceutical-ingredients","status":"publish","type":"post","link":"https:\/\/www.ainia.com\/en\/ainia-news\/new-market-needs-in-european-formulation-of-api-pharmaceutical-ingredients\/","title":{"rendered":"New Market Needs in European Formulation of API Pharmaceutical Ingredients"},"content":{"rendered":"<html><body><div class=\"wpb-content-wrapper\"><p><span data-contrast=\"none\"><span class=\"TextRun SCXW41880406 BCX8\" lang=\"ES-ES\" xml:lang=\"ES-ES\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW41880406 BCX8\"><span class=\"TextRun SCXW194446391 BCX8\" lang=\"ES-ES\" xml:lang=\"ES-ES\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW194446391 BCX8\"><span class=\"TextRun SCXW1005685 BCX8\" lang=\"ES-ES\" xml:lang=\"ES-ES\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW1005685 BCX8\">[vc_row][vc_column][vc_column_text css=\u201d\u201d]<\/span><\/span><\/span><\/span><\/span><\/span><\/span><span data-contrast=\"auto\">The European pharmaceutical sector is undergoing a profound transformation. Alongside traditional challenges\u2014such as strict regulation or equitable access to treatments\u2014new demands are emerging, driven by sustainability, digitalisation and personalisation. Within this context, the formulation of <strong>API pharmaceutical ingredients<\/strong> has become a strategic priority: it must not only ensure safety and efficacy but also align with the environmental, regulatory and technological expectations of the market.<\/span><br>\n<span data-contrast=\"auto\"> This shift is reshaping how <\/span><i><span data-contrast=\"auto\">api pharmaceutical<\/span><\/i><span data-contrast=\"auto\"> development and manufacturing are approached across Europe.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<h2 aria-level=\"2\"><b><span data-contrast=\"none\">Emerging Needs in Pharmaceutical Ingredient Formulation<\/span><\/b><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"134245418\":true,\"134245529\":true,\"335551550\":1,\"335551620\":1,\"335559738\":299,\"335559739\":299}'>\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">Today, pharmaceutical formulation cannot be understood without recognising the role of microorganisms as <strong><a href=\"https:\/\/www.ainia.com\/en\/ainia-news\/biofactories-sustainable-production-of-biological-molecules-for-industrial-applications\/\">natural biofactories capable of producing active ingredients,<\/a> <\/strong>excipients and other therapeutically relevant molecules. This trend is closely linked to the evolution of biotechnologies applied to the pharmaceutical industry.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">To guarantee the highest levels of safety and quality throughout the process, these innovative techniques must be <strong><a href=\"https:\/\/www.ainia.com\/en\/ainia-news\/good-manufacturing-practices-how-to-adapt-my-laboratory-or-workspace-to-gmp-regulations\/\">adapted to Good Manufacturing Practices (GMP)<\/a>,<\/strong> ensuring full control of process design, robustness and safety<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<h3 aria-level=\"2\"><strong>3D Printing of Medicines\u00a0<\/strong><\/h3>\n<p><span data-contrast=\"auto\">3D printing applied to pharmaceutical manufacturing enables far more individualised therapeutic solutions:<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<ul>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Full Personalisation: <\/span><\/b><span data-contrast=\"auto\">Technologies such as semi-solid extrusion (SSE) or volumetric printing allow dose, shape, flavour and release profiles to be tailored to patient-specific parameters such as age, weight or individual preferences.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Controlled and Combined Release: <\/span><\/b><span data-contrast=\"auto\">3D-printed tablets can be engineered to release the <\/span><i><span data-contrast=\"auto\">active ingredient<\/span><\/i><span data-contrast=\"auto\"> at specific time points or combine multiple drugs into a single pill\u2014reducing polypharmacy and improving therapeutic adherence.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Improved Administration Experience: <\/span><\/b><span data-contrast=\"auto\">3D printing allows modulation of colour, texture and flavour (including confectionery-like formats), making administration easier and reducing the negative perception of medication intake, especially in children or patients with dysphagia.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Dosing Precision: <\/span><\/b><span data-contrast=\"auto\">3D pharmaceutical printers achieve exact dosing, eliminating variability found in manual or liquid-based methods, which can introduce errors of up to 30%.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<h3 aria-level=\"3\"><strong><img decoding=\"async\" class=\"alignnone size-full wp-image-184997\" src=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2025\/11\/ChatGPT-Image-23-jun-2025-08_35_35.png\" alt=\"3D printing technology creating personalised dosage forms for api pharmaceutical development and controlled drug delivery.\" width=\"1024\" height=\"1024\" srcset=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2025\/11\/ChatGPT-Image-23-jun-2025-08_35_35.png 1024w, https:\/\/www.ainia.com\/wp-content\/uploads\/2025\/11\/ChatGPT-Image-23-jun-2025-08_35_35-300x300.png 300w, https:\/\/www.ainia.com\/wp-content\/uploads\/2025\/11\/ChatGPT-Image-23-jun-2025-08_35_35-150x150.png 150w, https:\/\/www.ainia.com\/wp-content\/uploads\/2025\/11\/ChatGPT-Image-23-jun-2025-08_35_35-768x768.png 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\"><\/strong><\/h3>\n<h2 aria-level=\"2\"><b><span data-contrast=\"none\">Sustainable Active Ingredients: Biologically Derived Raw Materials<\/span><\/b><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"134245418\":true,\"134245529\":true,\"335551550\":1,\"335551620\":1,\"335559738\":299,\"335559739\":299}'>\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">The search for renewable, eco-efficient and economically viable solutions is accelerating the use of microorganisms as biofactories capable of producing sustainable <\/span><a href=\"https:\/\/www.ainia.com\/en\/ainia-news\/api-pharmaceutical-supercritical-fluid-extraction\/\"><strong>api pharmaceutical compounds from biological sources.\u00a0<\/strong><\/a><\/p>\n<p><span data-contrast=\"auto\">Biofactories\u2014microorganisms or engineered plant\/animal cells\u2014are used to generate high-yield active ingredients. They can produce entirely new molecules or replicate compounds previously obtained from non-sustainable sources, such as petrochemicals or endangered species.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">To enable industrial-scale molecule production, advanced tools from genetic engineering and synthetic biology are applied. Using expression vectors, standard genetic parts and gene-editing tools (including CRISPR-Cas9), cells are modified to:<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Introduce complete biosynthetic pathways<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Optimise gene expression and metabolic productivity<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"12\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Reduce by-products or toxins, increasing final API purity<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">This enables sustainable production aligned with GMP standards, while reducing resource consumption and energy demand.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<h3 aria-level=\"2\"><strong>Sustainable Production of Active Ingredients\u00a0<\/strong><\/h3>\n<p><span data-contrast=\"auto\">One of the most powerful and cleanest technologies<a href=\"https:\/\/www.ainia.com\/linea-idi\/ingredientes-productos-farmaceuticos\/\"><strong> for sustainable API production is extraction with supercritical carbon dioxide (scCO\u2082).<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n<h3 aria-level=\"3\"><strong>Key advantages of supercritical CO\u2082:\u00a0<\/strong><\/h3>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Functions as a non-toxic, fully recyclable solvent<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Operates at low temperatures, protecting sensitive molecules<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props='{\"335552541\":1,\"335559683\":0,\"335559684\":-2,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\uf0b7\",\"469777815\":\"hybridMultilevel\"}' data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Leaves no chemical residues; CO\u2082 is removed simply by reducing pressure or temperature<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">This positions CO\u2082 extraction as a strategic ally for companies developing next-generation <\/span>api pharmaceutical ingredients.<\/p>\n<h2 aria-level=\"2\"><strong><img decoding=\"async\" class=\"alignnone size-full wp-image-116346\" src=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2021\/11\/Bloque-4_Altex.jpg\" alt=\"Altex\" width=\"800\" height=\"533\" srcset=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2021\/11\/Bloque-4_Altex.jpg 800w, https:\/\/www.ainia.com\/wp-content\/uploads\/2021\/11\/Bloque-4_Altex-300x200.jpg 300w, https:\/\/www.ainia.com\/wp-content\/uploads\/2021\/11\/Bloque-4_Altex-768x512.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\"><\/strong><\/h2>\n<h2 aria-level=\"2\"><b><span data-contrast=\"none\">Integration of Digital Technologies<\/span><\/b><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"134245418\":true,\"134245529\":true,\"335551550\":1,\"335551620\":1,\"335559738\":299,\"335559739\":299}'>\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">Digital transformation is no longer optional\u2014it is a strategic requirement for pharmaceutical formulation in Europe. Digital tools are optimising processes from design and development to manufacturing and distribution.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<ul>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">AI for Molecular Design: <\/span><\/b><span data-contrast=\"auto\">Machine learning algorithms can analyse large datasets to discover new molecules, predict interactions and optimise dosages or formulations, reducing development time and cost.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Digital Twins and Unified Data Platforms: <\/span><\/b><span data-contrast=\"auto\">These tools simulate manufacturing processes in real time, optimise production parameters and ensure end-to-end traceability.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Blockchain for Traceability: <\/span><\/b><span data-contrast=\"auto\">Blockchain ensures the authenticity and safety of ingredients and medicines, generating immutable records throughout the supply chain\u2014from the API to the patient.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Robotic Automation and IoT: <\/span><\/b><span data-contrast=\"auto\">Integrated robots reduce human error and improve operational efficiency, while IoT sensors monitor critical parameters such as temperature and humidity during storage and transport.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Virtual and Augmented Reality (VR\/AR): <\/span><\/b><span data-contrast=\"auto\">Used to train personnel through interactive simulations of pharmaceutical formulation and processing, improving learning and reducing operational risks.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<li aria-level=\"3\"><b><span data-contrast=\"none\">Telepharmacy and AI-Enabled Dispensing: <\/span><\/b><span data-contrast=\"auto\">Digital platforms and intelligent assistants support access to medicines and patient adherence\u2014even in remote areas.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">The<strong> formulation of pharmaceutical ingredients<\/strong> is evolving rapidly as sustainability, advanced biotechnology and digitalisation redefine industrial priorities. From the use of microbial biofactories to produce more sustainable <\/span><i><span data-contrast=\"auto\">api pharmaceutical<\/span><\/i><span data-contrast=\"auto\"> ingredients, to personalised 3D printing and the integration of digital tools that optimise development and traceability, the sector is adapting to a new paradigm.<\/span><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"335551550\":1,\"335551620\":1,\"335559738\":240,\"335559739\":240}'>\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In this transition, technological innovation and a strong commitment to both health and environmental responsibility are essential to meeting the expectations of today\u2019s\u2014and tomorrow\u2019s\u2014European market.<\/span><b><\/b><span data-contrast=\"auto\">[\/vc_column_text]\u00a0\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><strong><em>\u00a0Funded\u00a0by\u00a0the\u00a0aid\u00a0program\u00a0for\u00a0hiring\u00a0young\u00a0professionals\u00a0specialized\u00a0in\u00a0internationalization <img decoding=\"async\" class=\"alignnone size-large wp-image-191112\" src=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1-1024x109.png\" alt=\"\" width=\"1024\" height=\"109\" srcset=\"https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1-1024x109.png 1024w, https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1-300x32.png 300w, https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1-768x82.png 768w, https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1-1536x164.png 1536w, https:\/\/www.ainia.com\/wp-content\/uploads\/2026\/02\/Imagen1.png 1878w\" sizes=\"(max-width: 1024px) 100vw, 1024px\"><\/em><\/strong><\/p>\n<p><span data-ccp-props='{\"134233117\":false,\"134233118\":false,\"201341983\":0,\"335559685\":720,\"335559738\":0,\"335559739\":0,\"335559740\":300}'>\u00a0<\/span><\/p>\n<\/div><\/body><\/html>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text css=\u201d\u201d]The European pharmaceutical sector is undergoing a profound transformation. Alongside traditional challenges\u2014such as strict regulation or equitable access to treatments\u2014new demands are emerging, driven by sustainability, digitalisation and personalisation. Within this context, the formulation of API pharmaceutical ingredients has become a strategic priority: it must not only ensure safety and efficacy but also align [&hellip;]<\/p>\n","protected":false},"author":249,"featured_media":184993,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1971],"tags":[],"class_list":["post-185005","post","type-post","status-publish","format-standard","hentry","category-technological-innovation"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Market Needs in European Formulation of API Pharmaceutical Ingredients - AINIA<\/title>\n<meta name=\"description\" content=\"Explore how Europe is redefining API pharmaceutical formulation through sustainability, biotechnology, 3D printing and digital technologies.\" 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