Icrom, Italian CDMO, announces expansion of its lean manufacturig platforms for hi-tech small molecules

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Active Pharmaceutical Ingredients (API) Contract Development and Manufacturing Organizations (CDMOs) specialize in the essential services of developing and manufacturing the key-ingredients for drugs, helping the pharmaceutical industries to focus on their core competencies, reduce their costs and accelerate the time-to-market for their new therapies. 

The CDMO sector has become increasingly vital and has witnessed significant growth in recent years, driven by the increasing demand for targeted therapies and biopharmaceuticals. 

Small molecules have continued to dominate the pharmaceutical landscape, accounting for a significant proportion of innovators’ pipelines as well as of the approved drugs. Despite the rise of biologics as advanced therapies, small molecules remain crucial due to their cost-efficient and sustainable manufacturing processes and well-understood mechanisms of action which make the worldwide pharmaceutical quest for new therapies still sustainable as well as affordable for the patients.  

CDMOs specializing in complex small molecules are nowadays uniquely positioned to leverage their expertise in the industrial synthesis and process optimization to meet the growing demand for targeted therapies, personalized medicine and specialty drugs which allow to address previously unmet medical needs. 

Icrom, a well established CDMO for complex as well as high potent APIs, has set at the beginning of 2024 a 4-years CAPEX plan of 30 millions euros to achieve a 100% capacity expansion in line with the Scope 1 and 2 of the GHG protocol. 

Icrom’s CEO, Pierfrancesco Morosini, explains that “in Icrom we believe that sustainability ethics along with the efforts for the digitalization of the industrial processes will be key competitiveness factors to navigating the complex global economic environment, as the European Industry grapples with unprecedented regulatory pressures, cost constraints and competition.” 

“The investment plan that has been set up in Icrom will greatly expand, over the next four years, the manufacturing capacity and capabilities at the site in Concorezzo, Italy. One portion of the new facilities (1000 sqm) will have a particular focus on highly potent API development and manufacturing, ranging the OEB5 and OEB6 classifications, as the demand for these type of products increases.» 

Icrom’s plan in expansion and technological innovation also aims to enhance production processes, improve yields, time and costs. This includes adopting advanced manufacturing techniques, such as real-time process monitoring and analytics (PAT) to identify and mitigate risks throughout the manufacturing process and the implementation of automated process controls, which can streamline operations and increase scalability.  

This involves also the application of the artificial intelligence (AI) and machine learning both to the improvement of existing processes as well as to optimize research and development efforts and accelerate project timelines. 

Morosini further adds that «the latest investment will be used also to erect a 3-floor building on a surface of more than 500 sqm for large-scale manufacturing, including reactors up to 10'000 Liters. This establishment will be additional to the so called «Clinical-Scale API Plant» just completed in 2023 and recently put under operations, that include industrial chromatography and cryogenic capabilities among the available technologies.» 

In 2024 Icrom has also acquired the French based CRO Holodiag sas (Holodiag - Solid State Solutions and Crystallization Process Development), widening its R&D capabilities to the field of solid state and crystallization studies of small molecules.  

Morosini describes this acquisition as highly strategic as it “marks the birth of the Icrom group as an enabler of advanced technologies for small molecules for the biopharmaceutical sector involved in the development of new drugs”.