Olon, a pharmaceutical manufacturer and global CDMO company, confirms the timeline for the construction of its new high potency API manufacturing facility in Rodano (Milan) and confirms that the installation and validation of the new small-scale production area within the facility has already been successfully completed. The installation of the large-scale production facility will also be completed shortly and completion is scheduled for January 2025. The large-scale production line will be fully integrated into the small-scale production line. This new facility is specifically designed for the production of payloads, linker payloads and high potency APIs and is already ready for the GMP compliant small-scale production line. In addition to state-of-the-art equipment enabling operations at the highest level of control, the facility has a dedicated quality control department as well as storage areas for APIs.

"It is a new line that is cutting-edge not only in terms of the technological standard of the production facilities and design, but also in the concept of a real 'factory within a factory', which includes a dedicated storage area and a quality control department. This allows safe and easy handling of highly active molecules and reduces the risk of contamination," explains Marcello Buson, Head of Global Operations at Olon Group.

The area is also equipped with an HPLC purification plant for product purification and a lyophilizer for subsequent isolation and has a wide range of analytical instruments.

Olon, which has many years of experience with high potency active pharmaceutical ingredients (HPAPIs), announced in May 2023 an investment of 25 million euros in a new high potency API facility at its Rodano plant (Milan, Italy).

The new project envisages the construction of a completely new building that will house a second “area” with the production facility, quality control, research and development, and all ancillary facilities.

 

Source: globenewswire.com

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