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Article / Jun 01, 2020

Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules

Drug Development & Delivery, June 2020

Special Feature, from page 63 to 71

 

Hovione: Particle Engineering for Small & Large Molecules

Hovione has strategically decided to explore niche areas that are difficult to tackle and can benefit from its expertise in particle engineering. Examples include the oral delivery of Amorphous Spray Dried Dispersions and the manufacturing of dry powders for inhalation. Historically, Hovione has mainly focused on small molecules and their pre-formulation, by means of particle engineering, to overcome solubility limitations or to render them suitable for inhalation. In recent years, Hovione has experienced some challenges with large-molecule particle engineering, but intends to increase its activity in this area. “The delivery of large molecules is leading us to novel areas of aseptic particle engineering that we will be introducing in our portfolio,” says Teresa Alves, PhD, Senior Director, Science & Technology, Hovione. Dr. Alves adds that there are opportunities to apply lessons learned with small molecules to large molecules. “We see a trend in the increased delivery of biologics by inhalation, particularly dry powder inhalation, including the delivery of peptides, proteins, hormones, DNA, RNA, etc. We are also actively working to process low bioburden biologics to solve difficulties that our clients experience in limited shelf life, high viscosity, and new areas of administration.”

Márcio Temtem, PhD, Site Manager, R&D services, Hovione, explains how the company’s sponsors have benefitted from Hovione’s experience in spray drying. “Spray drying scale up runs with minimum work at scale,” he says. “This is what we call Development by Design. By relying on stasticial and mechanistic models, databases, and scientific know-how, we can save API and time required for CMC process development. We have successfully applied these tools to biologic molecules, namley proteins, antibodies, and fragments of antibodies, and some of these solutions have evolved to commercial manufacturing.”

 

 

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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. Hovione’s Expanded U.S. Site in East Windsor, NJ  The first phase of the expansion in East Windsor, NJ, delivers a new 31,000 square foot facility and houses two size-3 spray dryers (PSD-3). This additional capacity allows Hovione to meet increasing customer demand for ASD development and good manufacturing practice (GMP) commercial production. GMP operations are scheduled to commence in the second quarter of 2026.  Hovione has also acquired 15 acres of neighboring land, strategically positioning itself for future growth and evolving customer needs for U.S. manufacturing. The newly acquired greenfield site will provide future support for PSD-4–scale commercial production as well as continuous and batch tableting production. 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 included 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 – 300 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. With proven leadership in spray drying to manufacture ASDs, Hovione is able to support pharmaceutical companies by solving their solubility challenges efficiently and reliably.  Partnering with a CDMO that combines global leadership, advanced technologies, and the necessary manufacturing capacity in the U.S., drug developers can expedite time to market, ensure quality, and deliver innovative medicines to patients faster.  If your company is seeking access to the latest spray-drying capabilities, expanded U.S. manufacturing capacity, and an accelerated path to regulatory filing and commercialization, contact our team today.     

News

Hovione is Expanding Spray Drying Capacity for U.S. Drug Manufacturing

Oct 27, 2025

Aim to accelerate drug development and production with new technologies. By: Charlie Sternberg Hovione, an international integrated pharmaceutical development and manufacturing organization, and Microinnova Engineering, a leader in continuous process intensification, have partnered to advance the development of multi-purpose, plug-and-play modular equipment for flow chemistry. The companies will work together to test Microinnova’s modular manufacturing equipment, which is designed to offer greater flexibility, easier scalability, enhanced efficiency, and sustainable practices in active ingredient production, in an industrial setting. Together, the companies aim to accelerate process development, facilitate a seamless transition from lab to large-scale manufacturing, and ultimately reduce the time to market for pharmaceutical customers. “This collaboration with Microinnova underscores Hovione’s commitment to innovation in pharmaceutical manufacturing, with flow chemistry playing an important role in our long-term drug substance strategy,” said Dr. Jean-Luc Herbeaux, CEO of Hovione. “This partnership will allow us to shape and validate emerging continuous manufacturing technologies, which can potentially accelerate drug development and production.” Dr. Dirk Kirschneck, Founder and Strategic Director at Microinnova, added, “This partnership reflects our shared vision to deliver modular manufacturing technologies that support pharmaceutical innovation and manufacturing excellence. We are proud to join forces with Hovione to showcase the capabilities of our next-generation modular equipment in a dynamic CDMO environment, demonstrating its versatility for multi-purpose manufacturing.”   Read the full article on ContractPharma.com  

Press Clipping

Hovione, Microinnova Partner to Test Modular Manufacturing Equipment

Sep 24, 2025