Press Room

Article / Oct 11, 2007

Speech by Guy Villax at the VPP Star Presentation

East Windsor, New Jersey, 11 October 2007

Speech by Guy Villax on the occasion of the presentation of VPP Star plaque and flag

Mr. Ambassador [Mr. Joao Salgueiro, Ambassador of the Republic of Portugal to the UN]
Mr. Roskoski, [Mr. Gary Roskoski, Director- Marlton Area Office. OSHA] 
Mayor Mironov, [Ms. Janice Mironov, Mayor of the Township of East Windsor] 
Mr. Consul General [Mr. Francisco Azevedo, Consul General of Portugal in Newark]
Ladies and Gentlemen,
Dear Friends

I am very glad to be here with you.

I would like to thank the kind words from Mr. Gary Roskoski, Director and Mr. Martin Davies both of OSHA, from Mayor Mironov.

This is an important event for Hovione's Technology Transfer Center – we celebrate OSHA’s acceptance of our application to the VPP Star program.

This acknowledgement of an impeccable HSE record is something that I see as a reflection of the TTC’s standards, of the quality of the management of this site, and in a way this marks the coming of age of the TTC. Indeed this site is only 5 years old – and this is the first time that we have the chance to stop, invite our guests and friends and take a moment to look back. It’s not been easy, but we’ve clearly moved to the next step.

We have established the TTC as a member of an elite group – in the words of Edwin J. Foulke, Assistant Secretary of Labour – not just in HSE terms, but as a service provider of sophisticated R&D services to the pharma industry.

This is the correct moment to say a few words of thanks.

First to the East Windsor Township, its Mayor and Council – because they helped us decide to locate here, they welcomed us and told us “we’ll be as fast as you want provided you do it by the book!”.

Then to CUH2A, our architects that turned a dream, Dave, Bill and I had into reality – or at least into a blueprint – many sushi lunches at figuring out how to make it the best.

Turner and to Dion Hall of Eng Tech – for the hardware.

Millennium BCP bank – supported us all the way, and together with BES, BPI and CGD financed this investment.

The Consulate in Newark for endless stampings of endless papers.

The universities – Rider, Rutgers and Princeton – that lend us a hand only too often, train our young people so they will lead us in the future.

The Twin Rivers association – our neighbours… to whom we have tried very hard to be the opposite of a nuisance.

Certainly our customers – because at the end of the day they are the reason why we exist and succeed – I will pick a few names – Neurocrine Biosciences – because they gave us our first business here; and CVT and Astellas because they bet on us for an important new product.

I’d like to also thank all the Hovione people for their efforts and commitment in turning what back in 1999 and 2000 was but a dream – into a tangible reality that clients and competitors talk about, and journalists write about! Journalists have played an important role in our success - this is something we appreciate very much.

All Hovione sites perform over and above the regulations, and all get awards and commendations – they work hard to be a welcome part of their communities; they are often picked as an example to follow. So when I saw the letter from OSHA in Washington I was particularly pleased, because it came as a surprise – I did not even know the TTC had made the application – and it shows that whether they be in China or in America – Hovione people have the same culture, and look to meet the toughest challenges, to meet the highest standards – not because it is mandatory, but because this is just the way we work.

To achieve this means great team spirit, because Safety is everyone’s job – so cohesion and alignment are part of the whole process. This occasion is also a happy one because it marks an achievement, Diane and I are here, to share it with you – and to tell you how pleased we are to see after 50 years of hard work how we are able to get recognition for a job well done everywhere we go – and how this is the result of people that come from nearby, and from Macau, and from Portugal.

Going forward we have a great challenge – to continue to meet the standard. We all want to retain the VPP Star status – but to keep it requires effort and commitment – one day of lost work will cause us to loose the status… so we need to work hard because from where OSHA has put us, we can only go down… so I count on you.

Lastly I would like to give my congratulations to Dave that has led this project from its beginning and who should feel that all this is the achievement of a team he led, coached, pushed forward and got amazing results from. Congratulations to all of you for a great job well done – congratulations also to everyone else that worked here at the TTC, and may not be here to hear these words. Thank you – well done.

Guy Villax 
Chief Executive 
East Windsor, 11th October 2007

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The investment includes both continuous and batch tableting capabilities, as well as connect spray drying with tablet production at its East Windsor campus. Hovione, a Portugal-based contract development and manufacturing organization (CDMO), plans to install a continuous tableting line at its East Windsor, New Jersey campus, adding drug product manufacturing capacity and an integrated pathway from amorphous solid dispersion production through commercial tablet manufacturing. The $35 million investment will bring the first ConsiGma CDC Flex system to Hovione’s recently opened 89 Twin Rivers facility. The line is expected to be commissioned in late 2027 and will support both continuous and batch operation at throughputs ranging from 1 to 200 kilograms per hour, according to the announcement. The system will allow customers to use the same equipment for development, clinical, and commercial production, with formulation development possible using as little as 1.5 kilograms of material. Hovione said the line will also be equipped for containment to 1 microgram per cubic meter to support the handling of highly potent compounds. The new capability will also connect Hovione’s spray-drying operations with tablet manufacturing at the East Windsor campus. The company recently opened a 31,000-square-foot facility at the campus with two commercial-scale spray dryers for manufacturing amorphous solid dispersions (ASDs), completing a $100 million investment in its New Jersey operations. Hovione said the integrated setup will allow customers to move from formulation and particle engineering through tablet production under one quality system, reducing technology transfer requirements and eliminating traditional scale-up between development and commercial production. The ConsiGma CDC Flex platform was jointly developed with GEA as part of a collaboration that began in 2022, the company said. The system incorporates automated process controls and process analytical technology for real-time monitoring during production. Hovione already operates continuous tableting technology at its Loures, Portugal site. In August, the company completed a more than €40 million expansion of its tablet development and manufacturing center there, adding a second commercial-scale tableting line and increasing the center's manufacturing area by 25%. The East Windsor installation will extend Hovione’s continuous tableting capabilities to the U.S. and expand its integrated drug development and manufacturing services for oral solid dosage products. Read the full article at Pharma Manufacturing 

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Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world’s first ConsiGma CDC flex – a next generation continuous tableting line – at its East Windsor, New Jersey (USA) campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione’s recently opened facility, expanding the company’s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the US. CDC ConsiGma flex system The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. The new flex will operate in continuous or batch modes across a very broad throughput range (from one to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialised design within the flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 µg/m³, supporting highly potent compounds. Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients (APIs) are priorities. Inline process analytical technology (PAT) and automated controls also provide real-time quality monitoring. In parallel, the 2022 adoption of ICH Q13 regulatory framework, guidance specifically for continuous manufacturing of drug substances and drug products, provides harmonisation across the US, Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the US Food and Drug Administration (FDA) alone.  Developed jointly with GEA, the ConsiGma CDC flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these innovative developments simplify operation, improve efficiency and containment, and enhance operator safety. Read the full article at Pharma Press UK 

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Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization.   Read the full article at PharmTech.com  

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