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High Containment Manufacturing Expertise at Olon
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 capabilities for new generation molecules , which are the focus of much R & D in the pharmaceutical market . The general trend has been to steer the development of new therapies towards increasingly selective , and therefore increasingly potent , molecules .
Target therapies have an action that targets only the mechanism underlying the development of the disease . They are finding increasingly broad application in cancer ( primarily breast cancer ), but also rheumatic and respiratory diseases , and other major therapeutic categories with unmet needs .
Demand for potency
Improvements in treatment selectivity result in a demand for increasingly potent APIs . These ingredients require highly specific production technologies , systems and skills to meet the standard of containment procedures that can guarantee avoiding the contamination of operators and products . In this regard , Olon can offer partners 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 .
We have completed the new extremely high containment production line , OEB5 ( pictured ), with reactors that allow us to produce highly potent APIs in large-scale product batches ranging from 30 to 150 kg .
Starting with a few grams 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 CDMOs 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 .
Flexible platform
We have developed a flexible manufacturing platform able to support the customer along all the phases of drug development and then during the commercialisation as well , meeting the need for APIs that , depending on disease , can require a range from few kg to hundreds of kg / year .
“ We have built large-volume containment facilities to support the production of new drug classes , in particular oncology drugs ,” comments Giorgio Bertolini , VP of R & D at Olon Group “ 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 the patients who need it .”
The expertise in high containment processes is evident from the equipment 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 market . We are one of the leading experts in highly potent APIs , cytotoxic or other , 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 .
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 this available to its partners .
“ The ability to offer highly potent products translates into sustainability for the entire pharmaceutical industry ,” continues Bertolini . “ 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 means that we can significantly reduce the use of natural resources 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 , and we are moving into this future .” •
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981