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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Developing drugs with poor water solubility remains a major challenge for pharmaceutical manufacturers, because solubility impacts bioavailability and effective drug delivery. The vast majority of small molecule drug candidates have low water solubility. For more than two decades, the most successful particle engineering technology to improve drug solubility and bioavailability has been spray drying with an amorphous solid dispersion (ASD) platform. Spray drying improves the solubility of oral drugs, inhalable particles, and excipients, and increases the stability of heat-sensitive drug products. Hovione, recognized globally for its industry-leading spray drying capabilities, has recently completed a $100 million investment cycle to enhance its operations in New Jersey. This initiative has successfully doubled Hovione’s spray-drying capacity in the US, strengthening its position in the industry. 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It will also be a hub for centralized logistics, enhanced quality control laboratories, and next-generation research and development facilities.  A Global CDMO with a Growing U.S. Footprint  Hovione has operated in New Jersey for more than two decades, establishing itself with a strong U.S. presence for the production of drug substances, intermediates, and finished drug products. A continued emphasis on an integrated service offering, including spray drying, supports delivering innovative medicines to patients more quickly.  The expansion of the East Windsor site addresses the rising demand for U.S. manufacturing and is an integral part of the company's ongoing global growth strategy, with facilities in Portugal, Ireland, and Macau. The company continues to bolster a cohesive network for drug development and commercial manufacturing unified by a corporate quality system and governance framework.  The integrated offering enhances development speed and eases technology transfers by unifying the team's technical skills, proprietary technologies, and digital platforms to efficiently produce drug substance to drug products at a single-site, through Hovione’s “one site, one partner” vision. Furthermore, Hovione’s strategic partnership model offers customers exclusive access to advanced technologies and resources while aiding in the optimization of their development programs and ensuring sustained value creation.  End-to-End Spray Drying and Particle Engineering: From Grams to Tons Hovione is a global leader in spray drying and particle engineering. Services include solubility enhancement and controlled-modified release via development and production of ASDs of both small and large molecules, supporting various modalities. ASD-HIPROS, Hovione’s proprietary spray drying screening platform, identifies optimal formulations that offer optimal performance and stability. By increasing production volume in the US, Hovione will meet customer demand for spray drying services:  Development services in the laboratory (1 g – 1 kg batches)  Pilot scale production (0.5 – 25 kg batches)  Small-scale production (5 – 200 kg batches)  Large-scale commercial manufacturing (50 – 400 kg batches) A Commitment to Sustainability  Hovione’s core values include a commitment to sustainability at all facilities. This commitment is reflected in a business strategy that focuses on improving the communities where the company operates. Hovione’s sustainability policy and strategy align with the UN Sustainable Development Goals and include adherence to science-based targets in line with the Paris Agreement to address climate change. Meeting these goals has required a dedication to process intensification and ensuring sustainability of manufacturing processes. This has been possible through strategic planning and commitments from senior management to ensure sustainability is addressed throughout the drug development life cycle.  Partner with a Technology-Leading CDMO for U.S. Manufacturing   As demand for poorly water-soluble drug formulations continues to rise in the U.S., expanding spray drying throughput is essential to meet the need for innovative therapeutics. 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