Demand for HPAPIs and quality driving investments at Indena

By Dan Stanton

- Last updated on GMT

GettyImages/aurigadesign
GettyImages/aurigadesign
Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.

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.”

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Follow us

Products

View more

Webinars