The leading API supplier inaugurates new large scale high containment production line
Olon announces a new milestone of investments in its high containment manufacturing global platform. The Group, leading international API supplier, will be rolling out an investment of 27 million euros over 2022/2023 totally allocated to the expansion of further internal expertise and capacity of high containment production. This expansion is in line with the long-term business strategy of the Group that entails growth also expanding internal technology platforms, focusing on HPAPI and on biotech as well.
According to this vision, Olon announces also that it has just completed a new large-scale high containment production line (OEL < 1 mg/m3) of about 10 million euros, in its site located in Rodano, where the Headquarters is based.
The new line, just inaugurated and already operative, enables Olon to produce highly potent APIs in large-scale product batches ranging from 30 to 250 kg, serving the customer along all the stages of the scale up. “Now we are one of the few CDMO companies to offer the range of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialization, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule development phase” commented Paolo Tubertini, CEO of Olon Group.
Olon represents a leading expert in highly potent APIs, either cytotoxic or another kind of pharmacological action, in terms of full management of all aspects surrounding the plant, since its plants in Rodano and Settimo Torinese (Italy) were two of the first sites worldwide to operate in containment in the 80s.
The trend of pharma has been to steer the development of new therapies towards increasingly selective, and therefore increasingly potent, molecules, with the possibility of extending to all therapeutic areas and to oncology. Target therapies, i.e. drugs that are selective and therefore better tolerated by the patient, have an action that targets only the mechanism underlying the development of the disease. They are finding increasingly broad application in treating the world's most widespread oncological diseases (primarily breast cancer), but also rheumatic and respiratory diseases and other major therapeutic categories with unmet needs. Improvements in treatment selectivity result in a demand for increasingly potent active pharmaceutical ingredients. To be produced, these ingredients require highly specific technologies, systems, and skills to meet the standard of containment procedures that can guarantee to our customers to avoid the contamination of products and the exposure of operators.
Starting with a few grams in the GMP laboratory, the Group can rely on the internal flexibility needed to move on to batches of 1 or 2 kg, then tens of kilograms, followed by the 30 to 250 kg range which we can produce with the new line. Olon has developed a flexible manufacturing platform able to support the customer at every stage of highly potent APIs manufacturing, from very small to large scale, along the entire development chain. This is because it relies on all types of reactors regardless of required size, as well as its experience in managing high containment production processes which is among the most extensive worldwide.
“With the investments announced today” stated Paolo Tubertini “We keep on driving the leadership of this technology in the industry. The expertise in high containment processes is evident from the equipment we have at our disposal, but even more so from the in-house know-how that we have developed in recent decades, among the most extensive in the global API manufacturing market. We are one of the leading experts in highly potent APIs, whether cytotoxic or another kind of pharmacological action, in terms of full management of all aspects surrounding the plant: operator protection and training, policies and procedure, waste disposal, and management of related issues. Our knowledge in this area goes back a long way. Since then, Olon has continued to invest in the corporate culture of high containment and today it makes it available to its Partners”.
“Innovation Initiatives” is a long-term vision that drives Olon's growth. A strategy of significant investments in processes, capabilities, and state-of-the-art technologies to offer one of the most complete and reliable end-to-end integrated CDMO platforms. Globally, Olon has in plan 110 million euros of investments in strategic assets for 2022.
Olon Group is a global leader in the development and production of active pharmaceutical ingredients for CDMO and Generics, a reliable and preferential partner to the pharmaceutical, biotech, and specialty ingredients markets.
Headquartered in Rodano (Milan, Italy), OLON has 11 manufacturing facilities - 8 located in Italy, 1 in Spain, 1 in USA and 1 in India, designed in compliance with the strictest international requirements, and 3 branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China).