Press Room

Press Release / Aug 17, 2005

Hovione expands its range of services in Particle Design technology

To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying

To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying, an advanced particle design technology. Building on its accumulated expertise in all major areas of API development and cGMP manufacture, a full range of cGMP Spray Drying facilities operating at lab, pilot and industrial scale have now been installed at Hovione's API manufacturing plant in Europe and are currently being installed at Hovione’s Technology Transfer Centre in New Jersey, USA.

Building on the state-of-the-art spray drying industrial facility installed in 2004, Hovione now operates three additional units at lab scale and two others at pilot scale. All units comply to the most stringent cGMP requirements, allowing production from just a few grams for feasibility studies to full scale commercial production. Offering process scale-up throughout all phases of product development, Hovione's multi-scale spray drying facilities further widen our ability to provide customized solutions. Designed to support both Custom Synthesis and Generic Product customers, Hovione’s spray drying technology is complemented by complete R&D and analytical studies on particle properties as per specific product requirements, thus offering all expertise and capabilities for successful product development.

All Hovione spray dryers operate with nitrogen as the drying gas and are designed to support both aqueous and organic feeds. The manipulation of the operational parameters during spray drying offers the possibility to control the design of the particle and it’s attributes to meet the requirements of final product. Optimal sizing and shaping of particles, together with a variety of encapsulation options, can improve product stability and bioavailability. Spray drying also overcomes micronization issues associated with conventional grinding and jet milling processes.

The industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer. In conventional spray drying operation the process involves continuous atomization of solutions, suspensions and emulsions to generate from ultra-fine particles (below 5-10 micron) up to large particles (100 micron) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 microns) that can be directly compressible, have increased bulk/tap density, and demonstrate improved wettability/dissolution behavior. Operation in either mode can have applications for processing thermally labile APIs, co-processing APIs with inactive ingredients, as-well-as aid in the reduction of residual solvents and OVIs.

Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the Company is investing in other state-of-the-art technologies, which will further enhance our particle engineering capabilities.

 

About Hovione
Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs® for the Pharmaceutical Industry. With a 45-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization.

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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