Catalent extends global commercial spray drying capabilities in Europe

Company's customers to have immediate access to Niro PSD2 and PSD4 spray driers, which are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations.

This agreement immediately extends Catalent’s global spray drying offering by making available to Catalent and Catalent’s customers the dedicated use of the existing Niro PSD2 and PSD4 spray driers at the facility. These spray driers are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations as well as a secondary vacuum dryer. Catalent is now able to offer spray drying solutions from early-phase development through clinical supply and all the way to fully scaled-up commercial finished dose form manufacturing in Europe.

Under the terms of this agreement, Catalent will also have access to the facility’s integrated quality control and analytical capabilities with scientific support resources, enabling an end-to-end approach for customers.

“This agreement not only gives Catalent access to spray drying capabilities at Haverhill and its state-of-the-art equipment, but also an experienced and skilled team at the site with expertise in commercial-scale spray dried dispersions, which are frequently used today to overcome the solubility challenges with many new medicines,” said Jonathan Arnold, President of Catalent’s Oral Drug Delivery business unit.

“Sanofi Haverhill is our center of excellence for spray drying technology. The site has over a decade of experience in spray drying operations for commercial manufacture. We welcome the relationship with Catalent and are delighted that Catalent is investing in the innovation and resources at our U.K. facility,” said Philippe Clavel, Head of Sanofi Active Ingredient Solutions.

Earlier this year, Catalent announced a $40M investment in its Winchester, Kentucky facility that includes adding commercial-scale spray drying with high-potent handling capabilities, as well as other increases to the site’s capacity and its formulation and controlled-release tablet and capsule manufacturing capabilities. The Winchester facility will work alongside the Sanofi Haverhill facility to enable transfer and scale-up of spray drying programs from Catalent’s specialized early-stage clinical development sites located in San Diego, California and Nottingham, UK.