Press Room

DDF - 14th American Drug Delivery & Formulation Summit

Start
Monday, September 16, 2024 - 09:00
End
Tuesday, September 17, 2024 - 18:00
Location: San Diego, United States
Hovione presents the Biologics session delivered in the American DDF Summit, titled "Hovione Synthetic Sugars: Excipients Enhancing Protein Stability and Performance Across Bioprocessing", during the event, September 16-17

Hovione will be exhibiting at the American Drug Delivery & Formulation Summit (DDF), an event that brings together industry experts to address key challenges in pharmaceuticals, biologics, and device development. This edition features two days of presentations and networking opportunities with over 300 scientific leaders from pharma, biotech, and drug delivery sectors.

Don’t miss the chance to speak with our experts and learn how our extensive knowledge and experience can support your project from early stages of development to commercialization.

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On September 16, don’t miss our Biologics session 

Hovione Synthetic Sugars: Excipients Enhancing Protein Stability and Performance Across Bioprocessing

 

Process and formulation development for protein-based therapeutics needs to overcome several stress factors during bioprocessing, long-term storage of the bulk drug substance and of the final drug product. Stabilization of proteins against temperature, acidic pH, and shear stresses is crucial to maintain therapeutic efficacy and safety. Acidic conditions, common in viral inactivation and chromatography steps, can disrupt protein structure, while temperature exposure and shaking during mixing, transport, and storage can induce denaturation and aggregation. These destabilizing factors hinder the manufacturing, purification, and storage of protein therapeutics, leading to the loss of biological activity and potential immune responses.



To address these challenges, strategies such as using stabilizing excipients and optimizing buffer systems are commonly employed. Herein we present a platform of novel synthetic sugars as a solution for ensuring more robust biopharmaceuticals, with case-studies around the impact of adding these sugars to different model biomolecules under temperature, shaking and low pH stresses, showing that these can provide significant improvements in enhancing protein stability and manufacturing processes’ performance.

Session Highlights:

  • Overcoming the challenges of protein stabilization during bioprocessing.
  • Case studies showcasing enhanced stability under temperature, shaking, and low pH stresses.
  • Innovative solutions for improving the manufacturing and storage of protein therapeutics.

 

Schedule a meeting with our experts and discover firsthand how our innovative platform of synthetic sugars can improve the development and delivery of your biopharmaceuticals, ensuring optimal stability and manufacturing processability performance.

Eunice Costa, R&D Director of Hovione

Eunice Costa, Ph.D.

R&D Director

Eunice Costa joined Hovione in 2011 and currently leads the Research & Development activities in the field of Advanced Drug Delivery at Hovione. As Director, she is accountable for formulation and manufacturing process development as well as medical device design for advanced drug delivery modalities, supporting Pharma partners pushing forward innovative and generic medicines.

Since joining Hovione, Eunice has been actively researching the impact of particle engineering, particularly spray drying, formulation composition and processing on performance, stabilization and disposition of medicines, particularly biologics, supervising multiple PhD and MSc thesis. Prior to that she has held positions as junior researcher in organizations such as Genentech, TNO and academia. Eunice is a PhD in Bioengineering Systems from the MIT-Portugal program, during which she has investigated polymer synthesis and processing for biological applications. 

 

Schedule your meeting today and find out how we can support your project.

Find more about DDF Summit.

 

As a fully integrated CDMO we provide optimal solutions for your drug product with the right scale and flexibility - Learn more 

 

 

 

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The CDMO is preparing for its New Jersey facility to become fully operational this year. Hovione’s multimillion-dollar investment in expanding its East Windsor, NJ manufacturing site is quickly coming to fruition. Contract Pharma will be visiting the site later in April 2026 to provide a unique overview of what’s new. As a preview, the Contract Pharma team met with Hovione at the Drug, Chemical & Associated Technologies Association (DCAT) Week. David Basile, Vice President of Technical Operations—Americas, spoke at the opening Member Company Announcement Forum on March 23, 2026. In this interview, Basile expands on his remarks at the Announcement Forum. As he explains, Hovione is concentrating not only on New Jersey, but also on facilities in Ireland and Portugal. Contract Pharma: Good manufacturing practice (GMP) operations will soon be fully operational at the New Jersey facility. How has Hovione progressed through this process since the initial investment cycle was announced last fall—or even prior? David Basile: It’s been a really great journey and evolution over the last two to three years, conceiving the plan to grow our U.S. footprint. It was one of the reasons I came aboard with Hovione, to grow that footprint and build our commercial manufacturing prowess in the States. In New Jersey, we had originated [the site] as a tech transfer center. [But] we wanted to grow the organization to be more equivalent with our Portugal and Ireland sites, to do more large-scale manufacturing. So, this is part of that journey. And that’s not just bricks-and-mortar and machinery. It’s been people, talent, partnerships with clients, supporting functions such as QC [quality control] and analytical development. We’re growing our R&D teams as well. It’s a comprehensive approach to systems, people, and processes. CP: At the Member Company Announcement Forum, you ran through some of the major technical specifications of the NJ expansion. Can you talk about a few of the highlights and their capabilities? Basile: This year we’ll be starting up two PSD-3 scale spray dryers. This is a useful scale of machinery for our clients. It plays nicely between the PSD-2 and PSD-4 scales that we have elsewhere in the network. I’d say it’s medium-to-large scale capacity; we could do 30 metric tons annually out of this type of a unit. Product to product, that differs, but we do have products that put that kind of volume out in a PSD-3, so it’s not small-scale. Customers want to hear this because [they want to gain] efficiency with their batch size, and turnaround time. And when we campaign, we can really see significant throughput with this line up of new machinery and assets. The first machine that we will start up is a Hastelloy unit, which is unique. We took a pause [in the construction timeline] to make that upgrade, as we had a client that needed this configuration. There are additional clients that are interested in it too, because you can do acidic solutions and more aggressive kinds of formulations as well as solvent-based formulations. So that’s a unique element of that first machine. The second machine is being qualified later this year. Kind of a twin, but this one is standard 316 stainless steel.  CP: When a company brings a new or expanded facility online, new personnel often accompanies the new tech. What is the workforce addition that you expect, and what are the challenges of retaining top talent? Basile: In preparation for commissioning and startup of this new equipment, we’ve already ramped our headcount up, to be ready for GMP launch. We’ve added roughly 20 employees in preparation for this first machine to go [live]. Over the next 18-plus months, we could see something on a similar scale, getting us up to that 40–50 headcount range for that facility once it’s fully operational—and more later on in 2028, when we bring in the CDC [continuous direct compression] Flex unit. That’s what’s really going to be transformative about this new facility: that integrated offering coming to life. CP: Even if the NJ facility is top of mind right now, let’s also touch on some of your plans in Europe. What is your vision for expanding in Europe in the next two to three years? Basile: Ideally, Hovione’s aim is to build an equivalent manufacturing network, where clients can go to any site across the globe and get a similar breadth and scale of offering. We’re doing that now in Ireland, expanding our PSD-4 scale spray drying. One unit was recently installed. Late last year, it went live. Then there’s at least one other new PSD-4 in motion, which is really exciting, because [spray dryers] at this site were historically [exclusive to] larger chemistry manufacturing for API [active pharmaceutical ingredient] synthesis. So now, they’re further building their muscle with additional large scale spray drying capacity. On the Portugal side, there’s a lot of great things going on. Our Tejo campus, in Seixal, Portugal, is a massive, 4.5-million-square-foot plot of land, and there’s a new, modular facility going up there. It’s incredibly exciting. The design of the facility has been well-thought through with material flows [and] gravity-fed processes. Here, we minimize handling and [maximize] speed of processing. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets within each unit. So, why is that relevant? Because we can easily scale the number of fingers. When customers say, “we need more capacity,” we have the design on the table ready to go. We know how to execute, we know how to build and implement our technology platforms in a short timeframe. Deployment timeframes are truly becoming more and more relevant to our clients. CP: From last year’s DCAT Week to this year’s, what conversations are you having with industry colleagues about ever-changing geopolitics? Basile: We’re seeing that local, regional manufacturing capacity is vital. The concept of U.S. for U.S. and China for China seems to be a common theme that our clients are talking about. We happen to have an edge, as we [have already] started our journey of expanding our domestic U.S. capacity. So I think that’s a crucial piece to the puzzle, having dual-sided Atlantic manufacturing operations. The traditional global supply chain model is being challenged. Having soup-to-nuts sites that are fully autonomous in development, scale-up, tech transfer, all the way to commercial scale operation, is vital to Hovione, and how we’re protecting our supply chain. [Concerning] starting raw materials and Tier 2 suppliers, our procurement teams are out in the market making sure that there’s no single point of failure for critical materials [like] polymers and solvents that we utilize. We’re managing and mitigating risk by looking at those secondary suppliers across different geographies. CP: Encapsulating your planned expansions on both sides of the Atlantic, how would you sum up the value to the customer? Basile: It’s about speed-to-market. It’s one partner from early-phase development, clinical scale, all the way through commercial. They gain comfort, trust, and not just capacity and equipment time; it’s also about competency and depth of scientific expertise. We’re not just a traditional CDMO. There’s unique expertise in particle science and spray dried dispersions that we offer our clients that they don’t have. [With] traditional CDMOs, customers typically pay for time in [a particular] unit, for example, they’d say: “I need a machine, and I need [it for] three weeks.” Hovione is truly a partner to our clients. They’re leveraging our platforms, our know-how in spray drying, and our know-how in equipment design. Read the article at ContractPharma.com  

Article

Hovione Eyeing Manufacturing Expansion on Both Sides of Atlantic

Apr 06, 2026

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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As expansions come online, CDMO Hovione aims to meet industry's 'dual supply and sourcing' zeal: exec

Mar 26, 2026