Major pipeline growth for Olon

At CPhI Worldwide 2021 in Milan on 9-11 November, Italian CDMO Olon announced “a significant expansion of its pipeline of APIs, a result of its R&D investment strategy”. In all, it has added nine new active substances for the generics market by investing across several lines and at multiple facilities in its network.

This expansion, the company said, “represents diversification in terms of therapeutic areas and molecule types”. It has introduced new APIs for multiple sclerosis and anaemia to an already strong oncology portfolio, as well as in terms of implementing new synthesis routes. Among the key technologies it has used are biocatalysis, fluorination, cryogenic reaction and flow chemistry.

“Thanks to our experience in the generics market, we are known for our ability to adapt to specific quality, physical and chemical needs, as well as IP strategies that allow a prompt access to quality and affordable medicine generics as quickly as possible,” said CEO Paolo Tubertini.

This came shortly after the announcement of an expansion at the Mulazzano plant, which is dedicated to the production by enzymatic transformation. In partnership with Aguettant Pharmarmaceutical, Olon will install reactors, filters and ancillary equipment, as well as automating and digitalising some steps performed there.

A new line will be dedicated to the large-scale production of phosphorylated sugar, a key carbohydrate intermediate in the metabolism and storage of glucose, which is used to produce an injectable treatment. The Mulazzano site has been developing the process using renewable raw materials and reagents over many years.

Olon has also begun an investment in an HPAPI line at the facility of its Olon Ricerca Bioscience at Concord, Ohio. In the longer term, it will increase capacity to meet demand of up to a hundred grams and mirror the Italian facilities, which can produce HPAPIs on a larger scale. ORN added that it can now bridge the gap between the pre-clinical phase and commercial production.