Press Room

Event

ECA Conference: Spray Drying - Solutions for the Pharmaceutical Industry

Start

Tuesday, September 24, 2024

End

Thursday, September 26, 2024

Location: Lisbon, Portugal

The ECA Conference in Spray Drying takes place in Lisbon, Portugal, September 24-26. Register today

Spray drying is presently one of the most exciting technologies for the pharmaceutical industry, being an ideal process where the end-product must comply with precise quality standards regarding particle size distribution, residual moisture/solvent content, bulk density and morphology.

At Hovione, we are proud to be part of this innovative field and are excited to join leading individuals from industry, academia and regulatory agencies at the ECA Conference on “Spray Drying - Solutions for the Pharmaceutical Industry”.

Register today

and take advantage of the unique opportunity to visit Hovione's cutting-edge labs and manufacturing facilities in Lisbon, Portugal

The objective of the conference is to offer a platform for exploring spray drying technology and processes. Attendees will see firsthand demonstrations of solutions for diverse requirements and benefit from a site visit to gain hands-on experience in Spray Drying.

Speakers

Dr. Sune Klint Andersen, Janssen Pharmaceutica
Dr. Jean-René Authelin, Sanofi
Dr. Rainer Nicolai, F. Hoffmann La-Roche
Simon Phillips, Nova Laboratories
Dr. João Pires, Hovione
Dr. Thomas Quinten, Janssen Pharmaceutica
Dr. Inês Ramos, Hovione
Dr. Harald Stahl, GEA

Join the conference's sessions led by our experts

"Amorphous solid dispersions by Spray drying from a formulation perspective"

Inês Ramos, Ph.D., R&D Manager, Formulation, Oral Drug Product Development

Description: The manufacturing of Amorphous solid dispersions (ASD) has become an established and commercially demonstrated strategy to improve the bioavailability of poorly water-soluble drugs. ASD formulation typically requires the definition of multiple factors that can amount to extensive lab experimentation, hindering fast-to-market. This lecture will provide an overview of how to design a Successful Formulation for Amorphous Solid Dispersions Produced by Spray Drying, using a streamlined approach and a proprietary technology to expedites the screening phase with minimal API requirements. An overview of Hovione’s methodology, the evaluation process, and the studies typically utilized, insights on alternative excipients, as well as key information needed to make a formal assessment of the best candidates will be provided resorting to case-studies.

"Scale-Up of a Spray Drying Process"

João Vicente, Ph.D., R&D Director, Corporate Technical Services

Description: A spray drying process will be subjected to multiple scale-up steps throughout the product’s life-cycle, thus requiring a robust process understanding to control the products properties. The scope of this talk is to describe the knowledge and risk based methodology that guides the stages from the process design up to qualification and commercial phase of a spray drying manufacturing process. The lecture will focus on predictive tools used to support process/product development and scale-up activities.

"Tailoring Spray Drying Processes for Biopharmaceutical and Respiratory Formulations"

João Pires, PhD., R&D Senior Manager, Process Development, Inhalation and Advanced Drug Delivery

Description: This presentation is dedicated to exploring the primary requirements and potential challenges inherent in applications of spray drying with highly particular specifications such as biopharmaceutical and respiratory formulations. The discussion will delve into the intricacies of accommodating these specifications and de-risking the process during its evolution from laboratory-scale up to commercial manufacturing. By focusing on these nuances, the aim is to provide insights into optimizing the spray drying process for various pharmaceutical contexts, with a keen emphasis on achieving overall product quality with the shortest risk and time-to-market.

Key learnings:

Requirements & challenges when applying spray drying for biopharmaceutical and respiratory products
Adaptation of specifications and de-risking of the process during its development from laboratory scale to commercial production
Optimisation of the spray drying process for assuring product quality, minimize risk and assure shortest time to market


Inês Ramos, Ph.D. Manager R&D Oral Drug Product - Formulation Group	João Vicente, Ph.D. Director R&D Corporate Technical Services	João Pires, Ph.D. Senior Manager R&D Process Development, Inhalation and Advanced Drug Delivery

More about the Conference, Speakers and Programme

More about the Site Visit:

As part of the conference, registered participants will have a unique opportunity to visit Hovione's cutting-edge labs and manufacturing facilities in Lisbon, where research, development, and manufacturing activities take place.

In the labs you will gain access to Particle Engineering facilities, explore some of the most advanced analytical PAT tools, and get a close look at the specialized equipment used in spray drying development. You will also have the chance to observe analytical and process development operations, guided by Hovione experts.

During the visit to the manufacturing facilities, you will witness a state-of-the-art facility in action, showcasing a commercial spray drying unit.

Please note that availability for this exclusive site visit is limited, so securing your spot early is highly recommended to ensure you don't miss out on this opportunity to experience Pharmaceutical innovation at Hovione.

We provide bus transfer from the conference hotel to the Hovione sites. After the site visit there will be transfers to the airport and back to the conference hotel
Due to competition reasons, individual participants may be excluded from the site visit
Participants are required to sign a Confidential Disclosure Agreement (CDA) before entering Hovione sites

More about the ECA Academy:

The ECA Academy is the educational organisation established by the ECA Foundation. It develops and organises a wealth of international education courses, conferences (also as part of a GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc, European conferences are organised as discussion forums on new trends and developments.

If you have any questions about the Conference:

Tel.: +49 (0)6221 / 84 44 0

www.gmp-compliance.org

The Leader in Spray Drying

With the largest number of commercial projects, the best science and engineering, the largest capacity, and the most experienced team, Hovione can take your project from development to market like no one else.

Learn more on how to overcome your solubility issues with the best scale-up science.

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Today marks the start of CPhI Frankfurt, a huge trade show in Germany focused on the supply of pharmaceutical ingredients and other services to the drug industry. C&EN editor in chief Nick Perkins, life sciences editor Laura Howes, and reporter Aayushi Pratap are all there to meet drug outsourcing executives and take the pulse of the sector. In advance of CPhI, Cambrex and Wilmington PharmaTech both just announced big investments in US plants that make active pharmaceutical ingredients. And the Portuguese pharmaceutical services firm Hovione says it has completed a $100 million investment in New Jersey (story below). (...) Hovione invests in spray-drying in New Jersey The pharmaceutical services firm Hovione says it has spent $100 million to expand its operation in East Windsor, New Jersey. The facility spray-dries drug ingredients to create amorphous solid dispersions, which improve solubility and bioavailability. The Portuguese company says the new spray dryers will begin operating in the second quarter of 2026. The New Jersey facility opened in 2002, making Hovione one of the longest-established European pharmaceutical services firms in the US, CEO Jean-Luc Herbeaux says in a press release. Hovione says it has purchased land adjacent to the East Windsor site on which it can add new facilities for services such as spray-drying and drug tableting. Hovione is also investing at its sites in Ireland and Portugal. —Michael McCoy Read the full article at CEN.acs.org

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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 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. 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.

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