Press Room

Press Clipping / Dec 10, 2018

Life Sciences: Hovione increases production capacity while looking forward to its tenth year in Cork

Irish Examiner, December 10, 2018

2019 will be a very significant year for Hovione the contract pharmaceutical manufacturing company which helps bring new and off-patent drugs to market celebrates 10 years Irish-side.

Hovione which took over Pfizer’s former Loughbeg site in Ringaskiddy in 2009 has seen rapid growth over the last 10 years.

The company employs over 200 people in Cork and hundreds more at its other three sites spread over three continents with facilities in Lisbon (Portugal), Macau (China), New Jersey (USA).

Hovione has over 55 years of experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates.

The Cork plant plays a significant and strategic role within the Hovione network and that was certainly proven earlier this year when Hovione expanded its production capacity.

Having recommissioned a third production building at their site in Ringaskiddy Hovione went into production at this building in May of this year.

“This is the first time in Cork’s history that all three buildings have been running at the same time”, said General Manager Paul Downing who said it is an exciting time in the company’s history as Hovione Cork now have extensive manufacturing capacity with two Active Pharmaceutical Ingredient facilities alongside a Drug Product Intermediate facility that houses the largest, commercial pharmaceutical spray dryer in operation.

Dr Downing said he is optimistic about the future.

2019 he said is going to be a really big year for Hovione Worldwide as it celebrates its 60th Anniversary. 

The company was founded by Ivan Villax with his wife Diane Villax in Lisbon in Portugal in 1959.

“We have a very ambitious plan to be the Number 1 innovative, integrated pharmaceutical solution provider to the global pharmaceutical industry by 2028,” said Dr Downing. 


Our mission is to passionately turn any challenge into a solution by collaboration with our partners to develop great medicines.


"That is a company corporate goal so that requires all our facilities to grow and expand so this expansion plan is across the whole Hovione network including Lisbon, New Jersey, Macau and also obviously Cork.

“In short we give our customers what they cannot find elsewhere”, says Dr. Downing, who explains that the company’s customers come from the sectors of biotechnology, medium, speciality and large pharmaceuticals as well as generics pharmaceuticals.

“Hovione has a unique value proposition. We have more than 15 years of experience in pharmaceutical spray drying and have produced hundreds of batches for clinical trials and commercial supplies.

“We have a very diverse workforce. We currently have 15 nationalities onsite here in Cork. 

"Hovione is a fast, challenging dynamic environment and there are great opportunities for people with all skill sets at whatever age.

“Because the market demands different products you can work on multiple products and multiple projects at the same time. That gives people a diversity of experience. 

"We like to have a balance between promoting from within and recruiting from outside so therefore if someone has the desire to move within the organisation these opportunities arise.”

Hovione is constantly developing its talent pool and is a big supporter of and encourages apprenticeships for young people where they get an opportunity to gain very substantial and important skills allowing them to take up roles as electricians, fitters, quality control analysts, instrument technicians as well as automation technicians.

The Apprenticeship programme not only provides participants with the necessary technical and professional skills, it also provides valuable teamwork experience.

Valuable teamwork experience

“What we do find is that people can have very strong technical and academic skills but their team collaboration skills require us to invest in further training. 

"These skills would be automatically instilled in participants in the Apprenticeships programmes. 


In complex and large organisations like ourselves the interpersonal skills and an ability to work in small teams is important.


Hovione works with Skillsnet and other local academic institutions to help build capabilities that can take advantage of the many career opportunities available.

“We do College site tours and Master student placements. We work with the IDA on the IBEC EOP Programme which sees graduates spend six months with us and six months with our sister facility in Portugal mostly working as process engineers or QC analysts. 

"We hope these graduates will come and join us in our new process in Cork in 2019.

“We continue to work with the Portuguese Postdoctoral Graduate Placement Programme and with the Cork Education Training Board and this year we supported the IBEC Laboratory Apprenticeship Programme — we have the first two apprentices joining from that initiative this January in collaboration with CIT so we look forward to that as it has been a couple of years in the making.”

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 customer demands when necessary.

The company has a solid legacy of Corporate Social Responsibility — last year Hovione became a Certified B Corp – becoming the first facility in Ireland to have received this certification.

The company’s ‘Safety First, Quality Always’ culture is also something staff are very proud of - “we nurture it each day so that we do not take it for granted”.

“In the coming years we will continue to invest in additional capability and hire additional team members, launch and validate more new products”, says Dr Downing, who points out that the company is an active member of Biopharmachem Ireland, Cork Chamber as well as Business in the Community Ireland.

Hovione sponsors and supports local community initiatives as well as establishing crucial links with the academic and training institutions through its support of STEM — initiatives to encourage take-up of subjects such as science, technology, engineering and mathematics — as well as CIT Student placements and the Cork Training Centre.

Just last week, Hovione won the Corporate Citizen Responsibility Business in Community Ireland Mark.

Carbon footprint commitment

“We are one of 40 leading companies who have signed up to significantly reduce their carbon emissions between now and 2030”.

The pledge was made at a summit organised in Dublin last week by Business in the Community in Ireland, which describes itself as a network for sustainability.

“We are the first contact manufacturing organisation to win that award,” said Dr Downing. 

“We see that things like corporate social responsibility, being ethical in the workplace and within the community, reducing our carbon footprint are all important very important issues going forward.”

Hovione committed to engaging with its local communities

Hovione holds annual corporate social responsibility days and each year a particular organisation is chosen.

This year, the company supported SIMON Community — fundraising and giving practical support. Every Christmas, the company also facilitates food and gift appeals for the Society of St Vincent de Paul.

Dr Paul Downing said: “We are the first chemical / pharmaceutical company integrating this innovative community of companies that use the power of business to solve social and environmental problems. 

"As a Certified B Corporation, we want to contribute to redefine success in business meeting the highest standards of social and environmental performance, setting out Team Members for success and personal satisfaction and aspiring to use the power of markets to solve social and environmental problems.


This is a global movement of people using business as a force for good, with a vision that one day all companies compete not only to be the best in the world but the best for the world.


As well as expansion in Cork, Hovione is completing by the end of 2018 the qualification of its continuous tableting line at New Jersey (USA)

The capacity expansion program started in 2016 and will continue in the coming five years. 

Hovione has relocated its development services to a new centre with 7,000 m2 in Lisbon — fully equipped with the most recent tools to handle potent and highly potent compounds.

The Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. 

The company installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form as well as inhalation manufacturing capabilities. 

In New Jersey, Hovione has doubled the size of its development and manufacturing operations.

The decision to expand follows growing customer demand since Hovione started offering end-to-end solutions from drug substance to drug product from the Loures site in 2017.

Hovione increased production capacity in oral dosage forms in Portugal to strengthen their integrated offering. 

New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment. 

This ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. 

This increase in capacity helps Hovione customers to consistently bring products to market faster.

Paul looks forward to a very exciting year ahead. 

All these successes here at home, he says, would not have been possible without the continued support of the local businesses, IDA, Biopharmachem Ireland and the staff working at the Cork facility.

 

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International Pharmaceutical Industry journal speaks with Márcio Temtem, VP Strategic Business Management at Hovione, about how the company’s deep-rooted expertise in complex chemistry differentiates it within the CDMO landscape, enables seamless integration from drug substance to drug product, and supports partners in accelerating the development of high-potency APIs, advanced formulations, and next-generation therapeutic modalities. How does your complex chemistry expertise differentiate you from other CDMOs and how does it translate into helping partners accelerate the development of increasingly sophisticated APIs and formulations? Hovione has been associated with complex chemistry since its genesis. The company started by developing very tough chemistry on corticosteroids and antibiotics, which was an expertise that in the 90s we transferred into the contract manufacturing business.  Since then, Hovione has been exploring chemistry and its complexity in contract manufacturing through several angles. One is the ability to have assets across the globe and at different scales that allow the company to address various client needs. Another example of being able to tackle the complexity is having assets that can address molecules with different levels of potency. High potency is something that we offer in many of our facilities. Over the years, we have also tackled chemistries that are difficult to manage, like hydrogenations and cryogenic reactions. All these are part of a menu that we offer into the services. Hovione is always attentive to the client’s needs. The next step after chemistry, which typically tends to be particle engineering, either by means of crystallisation, controlled crystallisation, jet milling, or one of the technologies that we master most, spray drying. We keep attentive to these needs and we keep upgrading our toolbox with new hardware and new software. On the hardware side, we recently announced a partnership with Microinnova to embed continuous flow into our offering. On the software side, we have added micellar chemistry, a water-based approach to chemically synthesise active ingredients, addressing sustainability within the broader pharmaceutical industry. How does your manufacturing approach ensure seamless integration from drug substance to drug product both technically and operationally? Hovione has sites located in Europe, Asia, and North America, designed to offer clients a seamless, integrated approach across our network, not only in terms of processes, but also in terms of technologies. These facilities serve clients globally, although naturally some clients favour the local site. In terms of integration, Hovione offers the synthesis of the active ingredient, the manufacturing of intermediates such as amorphous solid dispersions, and the final drug product all in one site. Many companies claim to offer integrated services, but they do this across multiple sites. Hovione does the integration at one site, which reduces hand-offs, streamlines operations and ensures technical alignment. How do technologies such as spray drying and particle engineering, when combined with your chemistry expertise, enhance formulation performance and streamline scale-up timelines? Spray drying has become one of the most versatile technologies in our industry. It addresses challenges that both chemists and formulators face. Chemists are often concerned with problems such as yield, purity or ways of obtaining the right solid-state characteristics of the API, such as polymorphic form. Spray drying can provide a means of isolating materials that are very difficult to isolate by other methods. Examples of compounds that benefit from this include peptides and sugars. On the formulation side, spray drying addresses one of the biggest challenges in the industry: the poor solubility and consequently bioavailability of most of the new drugs. Seventy to ninety per cent of the new drugs in development are poorly soluble. Over the past 20 years, Hovione has developed a platform for making amorphous solid dispersions by spray drying. This platform allows new formulations to be developed with minimum quantities of API and in a short number of few weeks. The technology provides a seamless scale-up from grams to tons, gives clients line-of-sight to commercial production, and saves valuable API at early stages of development. It also allows integration between drug substance and drug product, linking synthesis, intermediate manufacture, and final product in a single site, which is unique in the industry. As molecules and processes become more complex, so too do supply chains. How does Hovione ensure consistency, quality, and regulatory confidence across global operations? Hovione maintains consistency, quality and regulatory confidence through a combination of global assets, standardised platforms and processes, and cross-functional expertise. Our sites are designed to serve global clients while maintaining local responsiveness. We offer high-potency capabilities and advanced particle engineering to address complex molecular challenges. By standardising technologies and processes across sites, Hovione ensures predictable outcomes and adherence to global regulatory requirements. This integrated approach supports reliable supply chains even as molecules and processes grow more complex. With the rise of HPAPIs, novel excipients, and emerging therapeutic modalities, how is Hovione evolving its chemistry and process capabilities to support the next generation of pharmaceutical innovation? We see a trend towards more complex molecules and increasing demand for high-potency compounds. Hovione continues to invest globally, expanding capabilities in high-potency APIs, novel excipients, emerging modalities, and emerging delivery routes such as inhalation or nasal delivery. Chemistry is used as a tool to enable these delivery routes, including synthesis, crystallisation to achieve the right polymorphic form, shape, and size, and optimisation of interactions with excipients. All this is interconnected with our platforms, and amorphous solid dispersions by spray drying, designed to improve bioavailability, the one with the most market credits. Our capabilities bridge drug substance and drug product development and allow us to serve commercial products of different volumes, from small batches to larger scales, all while handling high potency and complex chemistries.   Read the full article at International-Pharma.com  

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