Custom Development & Manufacturing Organization services have been one of the key areas of Indena’s expertise since 1990s.
Leveraging on its analytical and manufacturing capability, Indena positions its services in a niche to produce complex molecules having a very high value and requiring strong expertise for R&D, industrialization, high containment handling and production of highly-potent active pharmaceutical ingredients (HPAPI’s) from early stage to commercialization. The great differentiator as a reliable Western European producer is on HPAPI’s produced down to 20ng/m3 (Occupational Exposure Limit [OEL]), irrespective of their source, for which Indena is highly skilled and well equipped.
Indena has been investing in expertise and equipment for its CDMO services for years. The most recent expansion program includes the construction of a brand new R&D development laboratory of 400 m2 equipped with 12 fumehoods, 2 walk-in fumehoods, 1 laminar flow fumehood, 2 gloveboxes that will be able to host 15 R&D scientists.
This laboratory has been built specifically to handle HPAPI’s and the project will be up and running by mid-2024.
As a matter of fact, the increasing number of oncology new chemical entities (NCEs) and antibody-drug conjugates, coupled with a growing focus on personalized medicine, is shaping the demand for CDMO services. The HPAPI market is undergoing a shift towards NCEs characterized by higher potency, growing molecular diversity and segmentation for specific populations.
As shown by its long story and expertise, and unlike newcomers in the field, Indena can count on an extensive know-how in safely handling HPAPIs, complemented by state-of-the-art equipment and installations.
Nowadays Indena manufactures 12 commercial HPAPIs: fully synthetic, semi-synthetic and fermentation molecules. This area is now one of the core expertise of the company. Each substance within Indena is assigned an Occupational Exposure Level and allocated to the proper production line according to the required handling and containment rules. At Settala facility in Italy, Indena can handle HPAPI with an OEL from 1 mcg/m3 to 20 ng/m3.
Moreover, Indena has a fermentation department to carry out living cells-based bio-transformation or secondary metabolites production. Indena masters GMP microbial fermentation and bio-transformation, and thanks to the availability of high containment lines for the downstream phase, it is the ideal partner for fermentation HPAPI development.
