Olon to open new high potency API suite in the US

Published: 30-Jan-2024

A GMP high potency active pharmaceutical ingredient (HPAPI) suite, currently under construction at the Olon US site in Concord, Ohio, is the centre of excellence for early development of APIs within the Olon Group

This adds to the significant commercial scale expertise and capabilities of the Segrate and Rodano sites near Milan, Italy, and it is part of an important growth of capabilities for handling HPAPI in the group where the company has invested overall around €40m in the last few years.

“Our high potency API suite is not just a facility; it's a gateway to new possibilities. Engineered to meet the most stringent safety standards for R&D and GMP processes, this suite will operate for materials with an occupational exposure limit (OEL) of <1 µg/m3 (OEB5, SafeBridge 3)."

"This level of containment is essential for working with materials classified as highly potent, especially in the realm of anticancer drugs, when safety is paramount."

"This is highly integrated with the already existing capability in our Italian sites such as Rodano, to produce highly potent APIs in large-scale product batches ranging from 30 to 150 kg."

"Today we are one of the few API suppliers to offer the range of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialisation, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule development phase,” stated Giorgio Bertolini, Senior VP R&D Olon Group.

The HPAPI suite will provide a secure and self-contained environment for working with these materials, ensuring the safety of operators and staff as they develop the synthetic process or manufacture your clinical grade materials.

As additional safety data becomes available, the site can adapt protocols accordingly, allowing scale up for 1-10 µg/m3 OEL (OEB4, SafeBridge 3A) or lower bands into the pilot plant using continuous liner and the portable filter dryer which is rated to OEB5.

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