Press Room

A pharmaceutical services pioneer cues up continuous tableting as it doubles manufacturing. Guy Villax, CEO of Hovione, stands in the central hall of the company’s new R&D center in Lisbon. On the wall beside him is a mural with photographs commemorating the family-owned pharmaceutical chemistry firm’s milestones since it was founded by his parents, Ivan and Diane Villax, 59 years ago. There is also a nearly floor-to-ceiling portrait of Steve Jobs, the cofounder of Apple. Guy Villax is fond of extolling innovation and inspirational figures such as Jobs and Charles Darwin, who on another mural is quoted regarding species’ responsiveness to change. That mural also nods to an evolution in how Hovione regards the scientists who work in R&D. His father, he explains, was a man of his times. “He didn’t give much space to empowerment and all that,” he says. Villax, on the other hand, has been giving employee empowerment a lot of space recently.   The 7,000-m2 R&D center was designed with low-walled cubicles and picture windows looking into labs and conference rooms. A large tote board on the second floor lists the company’s patents, with a good number of entries—failed applications—crossed out with red lines. Banners from the ceiling celebrate the launch of new drugs for which Hovione supplied active pharmaceutical ingredients (APIs) and other services. There were four in 2017, close to 10% of the 46 drugs approved by the U.S. Food & Drug Administration. Villax says he wants to get chemists to look up from the bench at the big picture. “It feels a little less inhuman, not doing the Charlie Chaplin things,” he says, referring to Chaplin’s skewering of the machine age in the film “Modern Times.” “If you give people a sense of what it’s all about and how they contribute, they fill in their batch records with greater care. But to keep people excited about doing new things, you have to give them the right tools.” R&D at headquarters is one thing. Manufacturing on three continents is another, for a family-owned firm with plans to double capacity at most of its sites. But Villax sees a continuum from the lab to the plant in which developments in both realms are guided by innovative science and customer demand. It’s a philosophy that has kept Hovione afloat as many other firms in the drug service industry get swallowed up by financial buyers or big corporations. Indeed, Hovione has been adding tools beyond the lab, including at its plant in nearby Loures, where it is doubling manufacturing capacity and starting up a finished-dosage drug plant it acquired in 2015 and then retooled. Meanwhile, the company is adding a second pilot plant at its smaller-scale facility in East Windsor, N.J., and commissioning the second of two manufacturing buildings at a large-scale facility in Cork, Ireland, capacity that has been mothballed since Hovione bought the site from Pfizer in 2009. The company has also added a wholly new tool in New Jersey—a continuous tableting plant­—for which it has a contract to work with Vertex Pharmaceuticals. Hovione will offer the service for other customers there and in Lisbon, where a similar plant is scheduled to be installed. Hovione invested about $100 million in 2017 and plans to spend as much again this year and next. The plan over the next three years is to continue investing, especially in Portugal, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m2 analytical lab. Hovione’s capacity expansion is ambitious but somewhat conventional for a firm whose major investments have historically startled industry watchers. In 1985, for example, Hovione built a plant in Macau, the first instance of a European drug service company investing in China. In 2002, it opened the New Jersey plant, starting a trend of European firms establishing small-scale beachheads in the U.S. Then came the Cork acquisition, which, in addition to bulking up manufacturing capacity with a plant Pfizer no longer needed, brought a huge spray-drying facility. Hovione pioneered and remains a leader among firms offering this now-popular service. If anything, the move into tableting is a bit of catch-up for Villax, who not long ago spoke skeptically of peers adding final-dosage service to chemistry. The merger of DSM’s pharmaceutical chemical business with Patheon’s finished-drug service was a seeming vindication of this one-stop-shop approach. Several other firms, including Siegfried, Carbogen Amcis, and Aesica, also invested in dosage-form manufacturing, as Hovione held fast with chemistry alone. Villax finally blinked in 2015, purchasing a plant literally over the fence from Hovione’s main site in Loures. Villax insists he would never have added dosage services if the plant weren’t adjacent to API manufacturing. He says the company now has two customers for which it does particle engineering, API synthesis, and final product manufacturing at the one site.   He emphasizes that Hovione had signed up Vertex for continuous tableting before committing to the cutting-edge technology in New Jersey. Dosage-form service “is not a leap or change in direction,” he insists. “Who do you think showed us the way? The clients.” In New Jersey, site general manager Filipe Tomás is focused on increasing capacity for clients in the early stages of drug development. “This site cannot be at maximum capacity,” he says. “We expect to be at 60% to 70% occupancy and always be a door to customers when they have a lead.” And that door is about to open on continuous tableting, which is beginning registration runs and is set to go into commercial production next year. Hovione’s hope that the service will be of interest is borne out several miles away at the Rutgers University Engineering Research Center for Structured Organic Particulate Systems. There, engineers have worked with Vertex and Janssen Pharmaceuticals, firms that Douglas Hausner, associate director of industrial liaison at the center, describes as early adopters. Hovione hired several students and engineers from the center as it secured the contract with Vertex. Tomás sees the addition of tableting as a natural progression in pharmaceutical services rather than a break from Hovione’s chemistry tradition. The new apparatus, a three-story rig with a belt of tablet troughs running from top to bottom, is utterly unlike the pilot reactors elsewhere in the facility. “This is a technology that we think adds value,” specifically that of speed to market, Tomás says. He points to a newly constructed space near the tableting machinery in which the company may add blister packaging, a service Vertex is not currently signed on for. The site has also doubled its research space with the creation of an open environment that mirrors the new Lisbon center. Along with a significant increase in staff, the New Jersey labs have increased technical firepower in areas such as particle design and engineering. Back in Lisbon, Cláudia Ferreira, general manager of R&D services, says research and technology have seen many changes in recent years but have still followed one basic course. “Hovione always takes advantage of its core way of working, which is science driven and innovation driven. That hasn’t changed.” Rafael Antunes, senior director of R&D, adds that remaining a family-owned company allows Hovione to take risks and make long-term investments, including in its research endeavors. “We like to be challenged,” he says. “We feel we have to differentiate ourselves from the competition, to set the bar high on the technologies we adopt, and to have the right people.”   Hovione employs about 90 Ph.D. scientists. Under a program launched five years ago, 11 Ph.D. students are doing research at the firm. The four who have completed their program have been hired by the company. “What you have in our industry, as in so many others, is an expansion of knowledge and technology,” Villax says. “You have to keep up, and you have to solve problems faster.” James Bruno, president of the consulting firm Chemical & Pharmaceutical Solutions, says that Villax makes some risky moves but that they tend to pay off, with the latest venture in continuous tableting appearing to be another good one. “Sometimes I’ve scratched my head and said, ‘What is he thinking?’ ” Bruno says. “But five years later, you got to go back and say, ‘Well, you know, that was a pretty good idea.’ I think Guy always has a tendency to be a step ahead of everybody else in general. He’s doing things that people are thinking about doing.” Villax says he’s often challenged on the question of whether, despite a good run, a major disruption in pharmaceutical technology might “get Hovione bankrupt.” This, he admits, is a good question. But he also points to an uninterrupted line in pharmacology development that has yet to be disrupted by genomics, digital technologies, and other game-changing leaps in science. “I think the pharmacy is something relatively unchanged for 30,000 or 40,000 years. Even when you had hunters and gatherers, I’m sure there were some people who knew what certain plants did for you. So I can’t see what is really going to disrupt us,” he says, smiling. “Famous last words!”   Read the article at C&EN online  

Press Clipping

Hovione bulks up, with a twist

Nov 12, 2018

Loures, Portugal, October 17, 2018 – Hovione announces plan to increase production capacity in oral dosage forms in Portugal, to strengthen the integrated offering. New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment. This decision to expand follows growing customer demand since, one year ago Hovione started offering end-to-end solutions, from drug substance to drug product, from the Loures site. As a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help Hovione customers to consistently bring products faster to market. “Hovione has a unique value proposition when it comes to processing amorphous solid dispersions. Our Company has more than 15 years of experience in pharmaceutical spray drying and has produced hundreds of batches for clinical trials and commercial supplies.  Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value added services they expect from us. They want to keep their product in the same capable hands. This investment shows our commitment to listen to our customers and continue to support their evolving needs,” says Frédéric Kahn Vice-President of Marketing & Sales at Hovione. In parallel Hovione will be completing by the end of 2018, the qualification of its continuous tableting line at Hovione New Jersey, which will enable the site to offer end-to-end solutions for US customers that are keen to keep their supply chain local. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. Globally within our R&D we added new labs, new drug product centres, pilot plants and our state-of-the-art particle engineering technologies both in the US and in PT. Locally, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. We also installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. In New Jersey, Hovione doubled the size of its development and manufacturing operations. In Cork we also expanded our chemical synthesis capacity devoted to contract manufacturing. Overall, Hovione’s steadfast growth is the result of an integrated synergy that allows the company to serve both the global markets and also to respond to specific customers’ demands whenever necessary. At Hovione, we want to be the CDMO that customers like the most, therefore we put the customers’ needs at the centre of everything we do relying on three growth pillars: operational excellence, customer centricity and the team members’ engagement.   About Hovione Hovione has almost 60 years of experience as a Specialist Integrated CDMO offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.    

Press Release

Hovione increases production capacity

Oct 17, 2018

Integration of new modeling and analytical tools with flow chemistry are notable trends A key focus of the pharmaceutical industry today is increasing efficiency and productivity to reduce cost and time to market. These issues are being addressed across the entire development lifecycle, including in API development labs. From improvement of existing technologies to the introduction of more advanced analytical instruments and modeling software, development labs are focused on increasing speed of optimization and reducing issues during scale up. Need for speed Innovation in API development labs is taking place at all pharmaceutical companies. Adam Kujath, senior director of global manufacturing sciences and technology at Alcami, points out how this innovation is being driven largely by smaller pharma and biotech companies. “Speed is the most important thing for these organizations as they work to get into and through the clinic as quickly as possible. Therefore, most investments are not necessarily for exotic new technologies, but rather expansion and improvement of those that drive more efficient throughput,” he comments. Examples include robotic screening equipment, parallel reactors, and more advanced in-line analytics to support process characterization. Flow chemistry for the synthesis of APIs is an important trend in the industry, according to Rui Loureiro, director of R&D process chemistry development for Hovione. “Flow chemistry enables the implementation of chemistries that previously were not possible due to a lack of technology. As a result, chemists are gaining access to new methods for producing new and more complex molecules,” he says. It can also dramatically reduce scale-up times because the same equipment can be used in the lab and for production, just for longer periods of time and/or in multiple copies. A side benefit of the interest in flow chemistry is improvements in process analytical technology (PAT)—including nuclear magnetic resonance (NMR) spectroscopy and high-performance liquid chromatography (HPLC)—are being developed to allow their use for continuous manufacturing, according to Loureiro. Equipment integration and miniaturization Not only advances in equipment technology, but the ability to integrate different aspects of API development laboratory initiatives is helping to speed up activities. Access to a growing selection of miniaturized probes with high resolutions allows researchers to more quickly gain a better understanding of how crystals are formed and how polymorphic forms can be controlled, according to Jerod Robertson, a senior process chemist at Hovione. He points to smaller probes for focused- beam reflectance measurements and particle vision and measurement from Mettler Toledo as examples that allow performance of crystallization studies in smaller reactors using smaller quantities of expensive API. “Using less material is important since at the beginning of development there normally aren’t significant amounts of product available, but the shape and size of the obtained crystals should be understood as in-depth as possible because these parameters can significantly impact process development down the road to reaching the commercial phase,” Robertson explains. Most notable for Alcami when it comes to equipment advances has been the integration of multiple systems, according to Kujath. “When a piece of equipment capable of performing automated, high-throughput synthesis or crystallization experiments is directly integrated with direct sampling for multiple forms of analysis on the same system, it drives efficiency, such as the Bruker D8 Discover HTS2. Better, more robust data sets can be obtained, making tools such as design of experiments more accessible for earlier development activities and thereby allowing Alcami to create stronger early clinical processes,” he observes. More intuitive software Advances in software are equally important as improved equipment and technology. “Software packages are becoming more intuitive, which is important as the databases behind them grow,” Kujath notes. “Scientists today build on the developments of those who came before them, and the software packages that exist today are making that information more accessible for application on a daily basis,” he adds. At Hovione, using the simple but effective Dynochem (Scale-Up Systems) and Visimix (VisiMix Ltd.) software packages for optimizing scale up and mixing processes and equipment have been great tools for chemists responsible for the scale-up of API syntheses. “The use of Dynochem has enabled Hovione to achieve faster development of unit operations such as solvent swapping, and it has also been a great tool for understanding reaction mechanisms, including those that lead to impurity formation,” Loureiro says. Such understanding helps the development chemists implement effective control strategies that ensure product quality. The use of tools such as Visimix provides chemists with a greater understanding of effects like mass transfer and mixing and how they can impact product quality, according to Robertson. This information can be used to gain insight into how reactions will run at scale or when they are changed from one piece of equipment to another. Hovione is also leveraging software designed for ab initio calculations, such as Gaussian calculations. “These types of software are very important because they provide chemists with a better understanding of the possible transition states that can be formed during the different steps in an API synthesis route. This information is helpful for identification of pathways that lead to impurity formation,” says Loureiro. Better modeling for greater control The software packages used at Hovione mainly help with modeling. The information that is obtained on process kinetics and impurity formation is used to determine the optimum control strategies, according to Robertson. The company also uses software such as SuperPro Designer (Intelligen) for batch process simulations and computational fluid dynamics software for modeling the scale up of processes when moving from the lab to large-scale production. The algorithms used in modeling tools are becoming more accurate and predictive in part because the data behind them continue to grow, according to Kujath. Alcami has seen that they are as a result useful for further refining processes. Better modeling for greater control The software packages used at Hovione mainly help with modeling. The information that is obtained on process kinetics and impurity formation is used to determine the optimum control strategies, according to Robertson. The company also uses software such as SuperPro Designer (Intelligen) for batch process simulations and computational fluid dynamics software for modeling the scale up of processes when moving from the lab to large-scale production. The algorithms used in modeling tools are becoming more accurate and predictive in part because the data behind them continue to grow, according to Kujath. Alcami has seen that they are as a result useful for further refining processes.   C. Challener, “Efficiency Demands Drive Advances in API Labs,” Pharmaceutical Technology 42 (10) 2018.   Read the article on Pharmaceutical Technology website

Article

Efficiency Demands Drive Advances in API Labs

Oct 02, 2018

In general, how has the efficiency and productivity of pharmaceuticals increased/evolved over the last 20 years and how much of this evolution is due the knowledge and experience contract development and manufacturing companies bring to the industry? The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change. Contract and development and manufacturing companies have brought a higher productivity and more efficiency to the pharmaceutical industry through higher and better utilization of assets and leveraging the knowledge and experience gathered by working in many different products. These companies contributed significantly to the industry during the last 20 years as their business model focused intensely on increasing productivity and efficiency. Over this same time period what has been Hovione’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years? Hovione’s mission was the contract development and manufacturing company that not only provides the benefits of an organization focused on development and manufacturing mentioned above but mostly an organization that brings innovation to the industry helping solve most complicated issues in development and manufacturing of medicines. For example, Hovione started many years ago devoting a significant effort in the understanding of particle engineering, how this could solve formulation challenges and what technologies could enable those engineered particles. Focusing on the inhalation and oral formulation of poorly soluble drugs through amorphous solid dispersions Hovione developed a wealth of knowledge and capabilities that have helped numerous companies developing new medicines that today help millions of patients worldwide that otherwise would not have been possible. Hovione today leads the development and manufacturing of amorphous solid dispersions by spray drying and has developed a wide range of new technologies like spray congealing and a combination of technologies that control particle size distribution, morphology, provide taste masking and controlled release properties that are of paramount importance for today’s pharmaceutical development and manufacturing. Specifically, what services and expertise does Hovione currently offer to assist pharmaceutical clients to bring new drugs to market? Can you talk about your Integrated Science offering, capacity expansion, and your continuous manufacturing technologies? Hovione constantly seeks new technologies, develops scientific knowledge and sees how we evolve our organization to solve issues for the pharmaceutical industry. Hovione today offers a comprehensive range of services from API to final drug product that include process development, clinical batch and commercial manufacturing involving experts in chemistry, process engineering, analytical sciences, particle engineering and formulation scientists. The development of a new medicine involves a wide range of expertise and technologies that Hovione has brought together ultimately (spray drying, microfluidization, spray congealing, co-precipitation) to provide better drugs and faster development so patients in need can have access to life changing medicines quicker. Hovione offers an integrated approach from API to drug product as mentioned above. This integration not only speeds up product development but also allows our organization, scientists and engineers to share product/process knowledge. Our strategy has been also to develop this integrated approach at the same location to facilitate all the complex process associated with developing a drug and outsourcing.  Therefore, Hovione started an investment program to add capacity at multiple locations (Europe and US) in API, spray drying and drug product formulation namely in tableting. Hovione believes that continuous manufacturing (in chemistry and drug product) brings a new way of developing and manufacturing medicines adding more quality and flexibility into the manufacture of medicines while allowing a faster development path by reducing the effort necessary in scaling up processes. Hovione has embraced these technologies and has invested in continuous tableting because we believe that this will be a transformational technology to the industry. Looking ahead, are there any drug development and manufacturing technologies being developed now that will help pharma companies bring innovative products to the market? How will Hovione meet this challenge for its current and future clients? Continuous processing is still a relatively new technology in the pharmaceutical industry. Its adoption will certainly help pharma companies to bring innovative products to the market faster. Hovione is very much interested in providing this option to pharma companies and having a contract manufacturing organization capable of providing this solution is of paramount importance for biotech companies and for the overall drug development industry. There are other technologies being developed to address the challenge of poorly soluble drugs and other particle engineering manipulation solutions that Hovione is evaluating with the goal to bring these technologies to market to provide companies with options and better results. Being an innovative company with a strong pool of scientists Hovione is very well prepared to take some of these technologies into an industrial reality and providing a real solution to develop innovative products.   Read the article at APR's website.    

Article

An Interview with Marco Gil, PhD

Sep 01, 2018

Rick Mullin interviews Frédéric Kahn at CPhI North America.         Hovione, which has likewise added services, including spray drying and finished-dose form manufacturing, in the past two years, continues to invest both at its headquarters in Loures, Portugal, and at its technology center in East Windsor, N.J. The company spent about $100 million in 2017 and plans to invest as much again this year and next, according to Vice President for Sales and Marketing Frédéric Kahn. Hovione opened a 7,000-m2 development services center at its main manufacturing facility in Loures, equipped to handle highly potent compounds. With 200 people hired over the past three years, the site now employs a staff of 1,600. Hovione may hire another 200, Kahn said. In New Jersey, the company is in the process of doubling chemistry and analytical service capacity and will begin operating a continuous tableting facility this month. Kahn says Hovione is interested in offering one-site shopping in Portugal and New Jersey. The plan over the next three years is to continue investment, especially in Portugal, Kahn said, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m3 analytical lab. “This is capacity that we are going to have to sell,” Kahn acknowledged, “but we pursued it by listening to our customers—by understanding what their requirements are in terms of API, formulation, solubility enhancements, and continuous tableting.” Kahn declined to call the added services a push toward the one-stop-shop model. Rather, he said, the firm will now offer one-site, full-supply-chain service in both Portugal and New Jersey.   Read the entire article    

Press Clipping

The good times keep rolling in pharmaceutical chemicals

May 29, 2018

Small gestures can truly change the world!   Ivan Villax, who was born on April, the 16th of 1925 in a small town in Hungary, left his country when he was 23 years old with a toothbrush in one pocket and a Chemical Engineering Diploma in the other. Later on, in 1959, already in Portugal, Ivan Villax, together with Diane Villax and two other Hungarians, founded Hovione. On April the 20th of 2018 we celebrated the second Ivan Villax Day across all Hovione sites (Portugal, Ireland, Macau and USA). Team-members across all sites went back to the community and ensured that they had a significant positive impact: Planted trees in Loures Did volunteering work with homeless in Cork Donated rice and oil in Macao Donated personal care items in New Jersey Loures In Loures, about 115 Team Members from the various sites and offices of Hovione participated in an action to replant 500 trees, pines and cork oaks on a municipal site. The planting of these trees will contribute to the reduction of the CO2 emissions to the atmosphere, thus reducing the effects of climate change caused by the accumulation of greenhouse gases. This initiative was supported and closely monitored by the field technicians of the Division of Green Zones and Forests of the Municipality of Loures. Cork In Cork around 120 Team Members volunteered at two homeless shelters, in which they painted and treated the gardens of the shelters. Furthermore, the result of a Cake Sale was also donated. This year, the focus was to work with a well recognised local and national agency, the Simon Community, to support the homeless people. Macau “Love Food Sharing" was a campaign organized by Hovione Macau with the cooperation of Centro do Serviço de Fornecimento Temporário de Alimentos da Caritas and its aim is to share food and love with the elderly. On this day, 31 Team Members in Macau visited 40 elderly families in need and gave them 80 bottles of cooking oil and rice sacks. New Jersey In New Jersey, over the course of a month, 110 people donated hundreds of personal care items for local community members in need. Additionally, Team Members attended an event where they put all the items together in care packages, which included inspirational words of encouragement and support to those struggling in the local community.

News

2018 Ivan Villax Day

Apr 20, 2018

Loures, Portugal, March 19, 2018 – Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey, with the aim to: increase capacity in existing technologies, like spray drying and grow in new areas of business to support its clients demand. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fifteen minutes away from the Loures manufacturing site, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas. In this period, Loures site expanded its drug substance reaction vessel capacity with a small scale production area and a new pilot plant, totalling additional 30 m3 of capacity. In addition, one pilot and two large scale spray dryers were installed at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. During the same time, Hovione doubled the size of its development and manufacturing operations in the New Jersey site, providing it with a full range of capabilities, from chemical & analytical development, through spray drying to formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large scale spray dryer and a continuous tableting unit. In the Cork site, Hovione is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing.  About half of this capacity will be ready for operation by May 2018. Over the next three years Hovione will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total area of 4,200 m2 for 165m3 of reaction vessel capacity and two large spray drying units, new formulation facilities that will enable the production of bigger batch sizes and a new building that will host additional 1200 m2 of analytical laboratories. This investment effort is being paired with recruiting and training new staff clearly illustrated by a 39% headcount growth in the last 2 years.  “This addition in capacity expansion will secure our growth and ensure that we continue to provide a truly integrated full-service solution to our customers, as well as showing Hovione’s strategy and commitment to further strengthen its global market leadership in Spray Drying” said Frédéric Kahn, Vice-President Marketing & Sales. “This capacity expansion plan is far more than a matter of production capacity solely. It aims to reorganize sites with new buildings, renew existing facilities and give operations the most advanced equipment in the market, to provide our customers and team members with the technology and the capacity they need to grow in a sustainable way. It is a significant effort and commitment from Hovione to stay ahead of and prepare for future demand.” said Nuno Almeida, Vice-President of Engineering.   About Hovione Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

Press Release

Hovione reports on recent capacity expansion and future plans to support growth

Mar 19, 2018

Loures, Portugal, March 8, 2018 – Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections revealed that all Hovione sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture. This is the first press release that reports on the outcomes of inspections in the previous year. This will now be a regular commitment, it is another feature of our commitment to transparency. Hovione inspections during 2017 Site Authority Date Type of inspection Outcome Portugal      Ministry of Healthcare of the Russian Federation   Jan 2017      PAI for an Intermediate Drug Product         GMP certificate granted   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Mar 2017 PAI for an Intermediate Drug Product Form 483 – 6 observations Site approved   Nov 2017 Surveillance inspection No Form 483 INFARMED, Portugal, EU   Jul 2017 GMP inspection to a new building GMP certificate granted Macau PMDA, Japan   Dec 2017 GMP inspection 11 minor observations reported Ireland Ministry of Healthcare of the Russian Federation   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Dec 2017 Surveillance inspection No Form 483 “Each inspection at Hovione is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.” said Joerg Gampfer, Vice President of Quality at Hovione. “We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.” added Frédéric Kahn, Vice President Marketing and Sales.   About Hovione Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

Press Release

Compliance at Hovione - Annual Inspection Review

Mar 08, 2018

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