The manufacturer announced this week the first synthetic high potency active pharmaceutical ingredient (HPAPI) has been produced at a new kilolab at its site in Settala, about 15km east of Milan, Italy.
The kilolab represented a multimillion-euro investment, and is being followed with another as Indena told us it is constructing a multi-purpose pilot plant, designed for grinding, extracting and purifying toxic plants.
According to Indena spokesperson Giusi Losi, the driving element behind these expansions “is the willingness to reinforce Indena’s presence in custom synthesis services, which are part of Indena’s culture and success.”
She added: “We are favoured in this specific moment by issues faced by Asian suppliers –in particular data integrity – and by the Italian Pharmaceutical Agency’s [AIFA] very high quality standards, which are globally acknowledged.”
Industry had been increasingly sourcing ingredients from lower-cost markets such as India and China to the detriment of Europe and the US, but over the past few years a number of quality and reliability issues have led to somewhat of a reversal. This so-called ‘flight to quality’ is especially true for innovative and more complex APIs.
Kilolab and piliot plant
The new kilolab has been designed to handle production of toxic substances characterized by an Occupational Exposure Limit (OEL) of 20ng/m3.
While confidentiality agreements stopped Losi revealing to us the name of the customer or molecule, she said it is a small molecule alkylating agent already being made at commercial scale, and the quantity is in the range of tens of kilograms per year.
Meanwhile the pilot plant is set to be ready by the end of the year.
“The multipurpose pilot plant is part of the general technological expansion undertaken by Indena to offer continuously better and more flexible CDMO services,” Losi said.
“Not only will the plant summarise all the technologies available within Indena group, but also will serve the production of non-cytotoxic intermediates for the HPAPIs kilolabs and industrial suites.”