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New Large Scale High Containment Production Line

The future trends in the APIs production

“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 Group, which in the past five years alone has more than doubled growth in strategic investments, is developing capabilities and expertise that make it the partner of choice for pharmaceutical companies, owing to the support it is able to provide throughout all stages of the development process. This includes for new generation molecules, which are the focus of much of the research and development of the global pharmaceutical market. The general trend 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 in particular 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 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. In order 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 operators and products. In this regard, Olan can offer Partners that are investing in the development and marketing of the most advanced drug classes one of the most flexible and solid platforms in the global market for the development and production for third parties of highly potent APIs and highly toxic intermediates.

Thanks to recent investments in its integrated manufacturing network, today Olon offers the capacity to develop and produce highly potent APIs, 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.

We have completed the new extremely high containment production line, OEB5, with reactors that allow us to produce highly potent APIs in large-scale product batches ranging from 30 to 150 kg. This expansion enables us to serve the customer along all the stages of the scale up, in conjunction with our sites. Starting with a few grams or macrolab in the GMP laboratory, we move on to batches of 1 or 2 kg, then several tens of kilograms, followed by the 30 to 150 kg range which we can produce with the new line, until reaching the largest quantities. Today 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 industrialisation, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule development phase. From a few grams to hundreds of kilograms.

We have developed a flexible manufacturing platform that supports the customer at every stage of drug development and also during commercialization, meeting API production needs, which can range from a few kg to hundreds of kg per year, depending on the disease.

“We have built large-volume containment facilities” comments Giorgio Bertolini, VP R&D Olon Group “to support the production of new drug classes, in particular oncology drugs. Despite containing a very small quantity of highly potent active ingredient, these have to be made available to a large number of patients worldwide. This requires large batch sizes of product, so as to allow pharmaceutical companies to guarantee access to therapies for all patients who need it.”

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 other 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: in the 1970s, our plants in Rodano and Settimo were two of the first sites worldwide to operate in containment, for the production of the first cytotoxic anticancer products on the market. Since then, Olon has continued to invest in the corporate culture of high containment and today it makes it available to its Partners.

“The ability to offer highly potent products translates into sustainability for the entire pharmaceutical industry” continues Giorgio Bertolini. “We are sustainable Partners since that we contribute to the global access to therapies, producing pharmaceutical ingredients that are more active and decreasing the quantity produced. It implies that we can significantly reduce the use of natural resources – row materials, solvents, and energy – and the overall impact on the environment. The result is a more sustainable drug supply chain. The future of our sector is to have increasingly small facilities with increasingly high activity, we are moving into this future.”