Press Room

Press Release / Sep 03, 2004

Hovione consolidates API expertise to provide advanced technologies in particle design

Hovione is expanding its scientific know-how and industrial production capabilities on a variety of technologies to widen its ability to provide customized solutions for advanced APIs (aAPI™).

Building on its accumulated expertise in all major areas of API development and cGMP manufactures, Hovione is expanding its scientific know-how and industrial production capabilities on a variety of technologies to widen its ability to provide customized solutions for advanced APIs (aAPI™).

Hovione has recently installed the latest design of advanced technology spray-drying facilities. This industrial unit is able to operate under the most stringent cGMP conditions. Designed to support both Custom Synthesis and Generic Products customers, Hovione’s state-of-the-art equipment enables it to offer a full range of API production capabilities. From few grams for galenic feasibility testing in a lab-scale unit to full production scale, Hovione offers all expertise and capabilities for successful product development.

The new industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer and is designed to isolate from either aqueous or organic solvent feeds. In conventional spray drying operation the process involve continuous atomization of solutions, suspensions and emulsions to generate ultra-fine particles (below 5-10 mm) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 mm) 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. 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, improves product stability and bioavailability. Spray-drying also overcomes micronization issues associated with conventional grinding and jet milling processes.

Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the company has also acquired a freeze-dryer and invested in Supercritical Crystallization and Sonocrystallization (crystallization assisted by ultrasound), which further enhances its particle engineering credentials.

In summary, Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs for the Pharmaceutical Industry. With a 40-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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