Angelini broadens its range of custom-hpapi capabilities

Angelini broadens its range of custom-hpapi capabilities

Published: 15 Nov 2019

Angelini Fine Chemicals Division, a leading Italian CDMO, announced increasing investments in novel technology and custom synthesis facilities. Over the last few years Angelini Fine Chemicals has been going through a robust investment program in chemistry and manufacturing capabilities with niche and high-barrier-to-entry technologies, such as High Containment and Flow Chemistry, to support, develop and manufacture of custom Advanced Intermediates and APIs. The expansion to new technologies at the Aprilia plant will let Angelini to reinforce its chemical technology portfolio offering to existing and future Customers, tailor-made services for custom synthesis.

At the moment, for small volumes products (such as Orphan Drug, Ophtalmics, rare diseases), a cGMP approved Kilo lab is present, and it is dedicated to the production of commercial APIs within those categories. The facility has a proper HVAC system, that guarantee a D classification. Moreover, a C classified hood is installed inside it and the access to the manufacturing area is allowed by means of personnel and material passboxes guaranteeing the highest standard in terms of potential contamination.

In order to direct the activities towards a customer service focused more on the production of high potent active molecules, Angelini has decided to expand capacity for research, development and manufacturing of High Potent products at its site in Aprilia, Italy.

The investment, started in 2017, consisting in commercial production suite for multi-kg High Potent product that is currently awaiting approval by local Health Autority (AIFA) and FDA after submission of DMFs started some months ago. It is foreseen also the expansion at kg scale production in the next years to include capabilities also from development projects. Installations are equipped with a proper HVAC system, pharmaceutical personnel and material passboxes, OEB5 isolators, the relevant utilities and all the necessaries manufacturing and analytical equipment with the highest standard available in the industry.

Completing this, the department can also provide full particle sizing needs of Customers from milled to micronized material always within protected environment to guarantee OEL of ≤ 1 µgr/m3.
Responding to the rising request of HPAPIs from the market, Angelini, as a leading CDMO, will take up the challenge, starting from the revamping and expansion of lab scale dedicated areas.