Press Room

Article / Oct 09, 2001

Article published in the CPhI Show Daily Newsletter

Show Daily CPhI, 9 October 2001

Dear Friends,

When the organisers of CPhI asked us to write an article about Hovione for the CPhI Show Daily, we accepted but the words that follow are probably not what they expected.

Last year we were basking in the sun-shine, it had been a golden time for the fine chemicals industry. The El-dorado was nigh, everyone was investing, the brave ones were buying plants, and some, driven by consultants were spending hundreds of millions of dollars on merging and acquiring other companies. The folly of the stock-market still had everyone in a frenzy. Life seemed sweet, easy and money was plentiful. The bankers in their excitement even decided that those making fine chemicals for the Pharma industry deserved some attention, they organised conferences and issued reports.

What a difference 12 months make. We are now in a recession, and the atrocities of September 11th are fresh in our minds. Everywhere one looks, it seems the colours have gone and the World is now in black and white. The articles one reads in the industry magazines talk of over-capacity, slowing growth, withdrawn drugs, unapprovable letters, cancelled projects. In some cases, the extent of the excess-enthusiasm was even given a number: a CHF1.3 billion goodwill charge on acquisition. The fascination with our business will now wane and the wave of interest will go elsewhere.

Quite a few of us will remain behind to pick the pieces left behind by this storm, tidy up the house and get it to move forwards. It will take a couple of years to get things back into balance, for the new-comers to find their direction, to establish with clarity who is a quality competitor and who has remained a trusted supplier. Those that expected to grow an API business in 4 or 5 years to $500 million in annual sales will be disappointed; those that have been at it for decades, focusing on compliance and excellence will continue to deliver work that satisfies customers. It is the repeat customer that drives growth; track record is not just the absence of recalls and warning letters, it is also the ability to consistently find solutions for customer problems - and in drug development there are plenty of tough surprises to solve.

Being in compliant manufacture is not just a question of dollars; being "cGMP" is not just a question of investment in new facilities. It needs time more than money, it requires having a team of dedicated technical people with many years of accumulated training. You do not "go fast" because of more resources or tougher deadlines; projects move fast well because your technical groups are trained and have done it together many times before, your people are aligned, and the range of skills is well covered and well balanced. Can a confederation of a dozen plants acquired through multiple mergers ever have a common culture, a same view of safety, let alone of quality? How do you manage all the site managers competing for the new project? Being successful in compliant manufacture is tough, it comes with years of nurturing and focus. Is it a surprise that the smaller independent companies do it better than the large giants ?

The divide is often the time-scale - some squeeze their people and business partners for their quarterly results, the annual budget takes precedence over customer satisfaction, available capacity is a dreaded cost - others look at available capacity as a positive thing enabling prompt service, and focus on what is in their control: sales in 2003 and 2004 (indeed the sales for the next 2 years were decided some time ago...).

The divide is often the choice of target: large companies look at sales and profits, they look at the share price and at how to cut costs, performance is judged on dividends. This is not so for all: some of us are motivated by customers that say thank you, some even compete for, and win, environment awards, but those that succeed, work as partners with their customers to develop new drugs; if they were lucky they started working together 5 year ago for the first 10 kilos; if they are statistically normal, they will have worked together on two failed projects well before they can claim to have put a new drug on the market.

Our industry is about saving lives. Though on occasion we are seen as polluters carrying out unsafe operations, and sadly accidents do occur, as in Toulouse only last week. Odd how energetic reactions, deadly reactants, explosives, corrosives and flammables all come together to make pills that cure disease, kill bacteria and destroy viruses. Safety First is not a negotiable item, chemistry and its engineering need competence and have priorities that business pressures must not be allowed to interfere with. Success in this business needs great leadership, the decisions are not easy - Bayer reminded us all how tough it can get.

At Hovione we did not participate in the Technicolor storm of the past few years. We had approved a medium term plan in 1994 and executed it with success; in 2000 we approved another medium term plan and we are taking it forward unchanged. It involved buying a field near Princeton to build a kilo lab and pilot plant to support early phase customers in the USA and to assist in the technology transfer to our larger plants when the projects so warrant it. The plan also aims to build additional capacity in our areas of strength: process chemistry, GMP manufacture, injectable grade APIs and corticosteroids. Some of this expansion is taking place in our plant in the Far East which is not encumbered with EINECS costs and speed limitations that slow the pace of drug discovery.

The companies that meet at CPhI play a critical role in the world economy. We are a key link in the worldwide health care system - without us the pharmacies would be empty. Ours is an important job, one we can be proud of. It is important that we should move ahead and get on with our business with professionalism, and keep distractions to a minimum.

Guy Villax
Chief Executive - Hovione

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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  

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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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