By Giorgio Bertolini, Director of Research and Development at Olon SpA

Olon’s long-term vision of ‘Innovative Initiatives’ is driving growth by significant investment in processes, capabilities and state-of-the-art technologies.

‘Innovation Initiatives’ is a long-term vision that drives growth at the Olon Group. A strategy of significant investment in processes, capabilities and state-of-the-art technologies will offer one of the most complete and reliable end-to-end integrated Contract Manufacturing and Development Organisation (CDMO) platforms globally. The 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 help 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 guarantee Olon’s customers can avoid the contamination of operators and products. In this regard, the Group 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 are among the most extensive worldwide.

Olon has completed the new extremely high containment production line, OEB5, with reactors that allow it to produce highly potent APIs in large-scale product batches ranging from 30-150 kg. This expansion enables the company to serve the customer along all stages of the scale-up, in conjunction with its sites. Starting with a few grams or macrolab in the GMP laboratory, it can move on to batches of one or two kilograms, then several tens of kilograms, followed by the 30-150 kg range, which it can produce with the new line, until reaching the largest quantities. Today, Olon is 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.

The company has developed a flexible manufacturing platform able to support the customer along all areas of drug development and then also during the commercialisation phase, meeting the need for production of APIs that, depending on disease, can require a range from few kg to hundreds of kg yearly.


“We have built large-volume containment facilities,” commented 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 Olon has at its disposal, but even more so from the in-house know-how that has been developed in recent decades, among the most extensive in the global API manufacturing market. Olon is 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 including: operator protection and training; policies and procedures; and waste disposal and management of related issues. Its knowledge in this area goes back a long way – in the 1970s, the company’s plants in Rodano and Settimo were two of the first sites worldwide to operate in containment for the production of the first cytotoxic anti-cancer products on the market. Since then, Olon has continued to invest in the corporate culture of high containment and makes it available to its partners today.

“The ability to offer highly potent products translates into sustainability for the entire pharmaceutical industry,” continued Giorgio Bertolini. “We are sustainable partners because we contribute to giving access to therapies. By doing so, we increase the potency of the active ingredient and we decrease the quantity of APIs produced. It implies that we can significantly reduce the use of natural resources –  raw 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.”