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Lisbon, May 21, 2024 – Hovione has placed fourth among the best companies to work in Portugal and was again the best in the Health Sector according to Randstad´s Employer Brand Research. The research, which was published yesterday, identified the 20 best employers in Portugal. This is the ninth annual edition of Ranstad´s study, which is based on a representative sample of the Portuguese workforce. The respondents evaluate companies according to a range of different criteria, including salary and benefits, job security, work atmosphere, and career progression opportunities. Employer branding can have a significant impact on an organization's ability to attract and retain top talent and so is becoming an increasingly important part of a company a strategy to address the talent shortage challenge.  Ilda Ventura, VP of Human Resources at Hovione explains that “Our global HR strategy is built on the need to attract, retain and empower our talented team members. Therefore, our Employer Branding needs to reflect the reality of who we are, so that we don’t just attract new talent but allow current team members to flourish. It also needs to capture the positive impact that Hovione has on the world, and how our innovative work relies on the knowledge and problem solving of our team members. We continue to work on refining and improving the work we do on our EB. This too is an important reflection of our values, and our belief in continuous improvement.” This is the third successive year that has been ranked as the most attractive company to work for in the Health Sector and placed in the top five overall  This recognition comes after Hovione was recognized as a Top Employer in all four of its global sites in January 2024, becoming the first company in Macau to do so.    About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.  

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Hovione again ranks among best employers in Portugal

May 21, 2024

The new company, which will be located in Portugal, will focus on the development of drug delivery solutions for emerging drug modalities. Cell and gene therapies represent a paradigm shift in modern medicine, offering unprecedented opportunities to address previously untreatable diseases. ViSync solutions will help address some of the manufacturing challenges caused by the complex nature of new modalities, with special focus on stabilization, cell or tissue targeting and drug payload delivery.  Lisbon, 9th May 2024 – The specialist integrated CDMO and leader in pharmaceutical spray drying and particle engineering, and iBET (Instituto de Biologia Experimental e Tecnológica), a private not-for-profit research intensive SME in the area of Biotechnology and Life Sciences, today announced the creation of ViSync Technologies, a new joint venture located in Oeiras, close to Lisbon. The newly formed company will focus on developing innovative technologies and scalable solutions to help pharmaceutical companies address formulation and manufacturing challenges in transformative cell and gene therapies. Hovione has a strong track record in industrializing new technologies and supporting Pharma Companies with their clinical and commercial volume manufacturing needs, while iBET has a strong biological background and a global reputation for its scientific knowledge of the new therapeutic modalities space, particularly cell and gene therapy.  New modalities, such as gene and cell therapies, RNA drugs and other complex biologics, are a rapidly growing segment of the pharmaceutical industry. They promise to bring breakthroughs to the treatment of a wide range of diseases and conditions, including cancer, genetic disorders, rare diseases and neurological conditions.  While this rapid growth has been driven by remarkable efficacy in addressing unmet clinical needs, the complex nature of the new modalities brings challenges, including limited drug administration options, immunogenic responses and off-target effects, issues with high dose delivery and high costs. The poor stability of these drugs is also an issue, resulting in the need for cold supply chains. ViSync will aim to develop novel technology platforms to address the unmet needs of pharmaceutical customers developing these transformative new products. “The creation of ViSync in collaboration with iBET marks an exciting new chapter in Hovione´s commitment to innovation”, said Dr Jean-Luc Herbeaux, Hovione´s CEO. “New therapeutic modalities have the potential to bring radical improvements to current standards of care and we are thrilled to partner with iBET, a world-renowned expert organization in this area, to develop technology platforms that help customers bring transformative therapies to patients worldwide. The first step will be to assemble a team who possesses the knowledge, expertise, and ingenuity needed to navigate the complexities ahead." “The establishment of ViSync in partnership with Hovione represents a pivotal moment in iBET’s dedication to pioneering research in advanced therapies,” stated Dr. Paula Alves, iBET’s CEO. “The immense promise of these new modalities is at our reach and we are delighted to join forces with Hovione, a globally recognized leader in technological industrialization and drug delivery. In this common endeavor, we will gather the scientific and technical competences and skills to support our clients and partners in delivering groundbreaking therapies to patients globally.” ViSync will develop its own lab facility in Lisbon and expects to be able to start its research and development work by the end of 2024.   About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About iBET iBET is a private non-profit institution devoted to biotechnology research, with 35 years of experience creating and transferring knowledge to the global biopharma and biotech sectors. iBET’s core expertise lies on the development of bioprocessses and analytical tools for Advanced Therapeutic Medicinal Products (ATMPs), including cell and gene therapies, vaccines, antibodies and other innovative therapeutic products. Leveraged by the emerging areas of Data Science and Translational Immunology, we offer bespoke R&D services from early-stage R&D to GMP manufacturing.  iBET’s infrastructure comprises cutting-edge laboratories, a GMP certified Analytical Services Unit, and a Late-Stage R&D and Bioproduction Unit, covering upstream and downstream process development, bioanalytical tools for critical quality attribute monitoring, to scale-up and tech transfer. iBET also hosts satellite laboratories of major pharmaceutical companies and serves as an incubation platform for start-up/spin-off companies. iBET is driven by its innovative and agile culture of continuous improvement and a strong sense of ambition, ownership and commitment in developing and delivering the best solutions to our stakeholders.  

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Hovione and iBET announce the creation of ViSync Technologies, an innovative new company that will develop solutions for unmet needs in cell and gene therapy

May 09, 2024

Hovione and GEA further strengthened their partnership, resulting in the launch of the ConsiGma® CDC flex Continuous Tableting Technology and the installation of a lab-scale R&D rig in Hovione´s facilities in Portugal. The agreement furthers Hovione´s ability to bring the benefits of continuous tableting, including reduced time to market and increased supply chain flexibility, to pharmaceutical customers globally. A presentation explaining how the technology has advanced will take place during a conference in Portugal (16–18 April), organized by Concept Heidelberg. Lisbon, March 18, 2024 – Hovione, the specialist integrated CDMO and leader in spray drying and particle engineering, and GEA, a global leader in process technology for the pharmaceutical industry, today announced the next stage of their partnership, with new development agreements, the launch of the ConsiGma® CDC flex as well as the installation of a new lab-scale R&D Continuous Tableting rig in Hovione´s facilities in Portugal. The two companies’ collective and complementary knowledge of continuous tableting is being applied to streamline the technology and make it more accessible to pharmaceutical customers worldwide. The two expert teams are collaborating to bring continuous tableting to the same level of maturity as batch tableting, thereby capturing the known benefits of continuous manufacturing while reducing the downsides. The ConsiGma® CDC flex (patent pending), has been designed as a truly versatile system which can operate seamlessly in both continuous and batch modes and offer both high and low throughput functionality. With a focus on user-friendliness, the ConsiGma® range will be augmented further with new developments to simplify routine development operations and introduce automated workflows and Smart controls interfaces, empowering operators to streamline production processes. GEA will also supply Hovione with lab-scale feeding and blending systems for research and development (R&D) applications which will bolster Hovione’s current GMP equipment for both continuous direct compression (CDC) and wet granulation continuous tableting and complement the non-GMP test capabilities of GEA in Wommelgem. Since signing the original collaboration agreement last year, the two companies have worked predominantly on two areas of the partnership: technology development and the joint promotion of continuous tableting. Presentations explaining how the technology has advanced will take place during the continuous tableting conference in Cascais, Portugal (April 16-18), organized by Concept Heidelberg, and another event Princeton NJ, USA (September 16-18), organized by Continuous Manufacturing Forum. “We believe that continuous tableting can offer significant benefits to our customers, not only by shortening time to market and reducing development and manufacturing costs but also by improving product quality and sustainability”, commented Filipe Gaspar, VP Technology Intensification at Hovione. “Through our collaboration with GEA, we aim to revolutionize the continuous production of oral solid dosage forms, making the technology more accessible and efficient for pharma customers.”   “Hovione and GEA benefit from a very large and complementary pool of continuous tableting experts; together, their collective knowledge is being applied to make continuous processing much less complex” stated Phillip Gabb, Strategic Business Director, Pharma Solid Dosage at GEA Pharma & Healthcare. “There is an industry perception that a lot of highly qualified and well-trained people are required to run a continuous line. The partnership’s intention is to simplify that, make it no different to running a standard tablet press and enable existing operators — with the right guidance — to use continuous manufacturing equipment.”  Background information About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world’s largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components and comprehensive services. With more than 18,000 employees, the group generated revenues of about EUR 5.4 billion in more than 150 countries in the 2023 fiscal year. GEA plants, processes, components and services enhance the efficiency and sustainability of customer’s production. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company’s purpose: ”Engineering for a better world“. GEA is listed on the German MDAX the European STOXX® Europe 600 Index and is among the companies comprising the DAX 50 ESG, MSCI Global Sustainability as well as Dow Jones Sustainability World and Dow Jones Sustainability Europe Indices.  

Press Release

Hovione and GEA Strengthen Partnership to Advance Continuous Tableting Technology

Mar 18, 2024

Hovione has entered into a license agreement with Dragonfly Technologies, Inc. to offer its customers the breakthrough micellar technology developed by Prof. Lipshutz. The agreement provides Hovione with the capability to develop chemistry-in-water, enabling a significant reduction in carbon footprint compared to conventional chemical processes relying on traditional organic solvents. Lisbon, March 07, 2024, Hovione, the specialist integrated CDMO and leader in spray drying and particle engineering, today announced it has signed an agreement with Dragonfly Technologies, Inc. to gain access to its micellar technology for chemistry-in-water processes, developed by Prof. Bruce Lipshutz of the University of California, Santa Barbara (UCSB). Hovione will further progress the technology to make it an integral part of its API manufacturing technology offering.  Micellar chemistry enables multiple chemical transformations to take place in nanomicelles dispersed in water, mimicking natural chemical transformations. The technology allows reactions to occur at lower temperatures and enables the reduction or even the avoidance of rare and expensive metal catalysts. At the same time, by minimizing the use of organic solvents, it can also reduce the carbon footprint of the desired chemical reactions.  Dr. Jean-Luc Herbeaux, Hovione’s CEO commented: "Manufacturing of APIs and their intermediates make up a significant proportion of the overall carbon footprint of pharmaceutical product manufacturing. Gaining access to Dragonfly’s groundbreaking micellar technology is a key step in our journey to introduce more sustainable manufacturing options at industrial scale. This proprietary process technology enables the use of less energy-intensive conditions, lower levels of precious metal-containing catalysts, and lesser use of organic solvents.” Prof. Bruce Lipshutz said: “I am delighted about the collaboration between Hovione and Dragonfly on micellar catalysis chemistry in water. Hovione has a long history of developing and industrializing innovative technologies for the pharma industry. This agreement will help ensure that aqueous micellar technologies will have wider and faster market adoption, benefiting the industry as a whole, by enabling development of nature-based sustainable processes in water.” This collaboration is another example of Hovione´s commitment to expanding its technology platforms and contributing towards creating a more sustainable industry. The company is investing both in new assets and innovative technologies to meet customer demand for more sustainable integrated and differentiated development and manufacturing services for drug substances, particle engineering, and drug products. This new agreement follows on from other partnerships recently forged by Hovione to deliver new innovative solutions to customers, including those with IDC, to offer innovative nasal delivery devices, with H&T Presspart for the advancement of a dry powder inhaler platform, with Zerion Pharma to commercialize the Dispersome® technology platform and with Ripple Therapeutics to expand the use of the Epidel® platform beyond ophthalmic applications. In addition, in November 2024 Hovione acquired ExtremoChem, a company with a portfolio of rare sugars which have shown potential in stabilizing biopharmaceuticals. Note to editor: Dragonfly Technologies, Inc. is a company founded by Prof. Bruce Lipshutz which is devoted to micellar technology. About Hovione: Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.  

Press Release

Hovione partners with Dragonfly Technologies to offer micellar chemistry technology to customers as a sustainable alternative to conventional chemical processes

Mar 07, 2024

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024

Hovione has been recognized as a Top Employer in all four of its manufacturing sites, in Lisbon (Portugal), Cork (Ireland), East Windsor (NJ) and Macau. Hovione is the first company to be certified as a Top Employer in Macau. Hovione’s 3 other sites, who had achieved Top Employer status in 2023, showed improved results this year.   Lisbon, January 18, 2024, Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, is delighted to announce that it has been recognized as a Top Employer in all four of its manufacturing sites. Hovione is the first ever company to be certified as a Top Employer in Macau. This marks a significant milestone in the company's commitment to fostering a supportive workplace environment and providing meaningful and rewarding roles for its team members. It also demonstrates that “One Hovione”, a company´s strategic initiative to give team members an equally high-quality experience across all locations, is delivering.  The certification program by the Top Employers Institute evaluates organizations through their participation in and outcomes of the HR Best Practices Survey. This comprehensive survey encompasses six domains and addresses 20 topics from Career Development to Leadership and from Employee Wellbeing to Equity & Inclusion and Wellbeing, amongst others. The program has certified and recognized over 2,300 Top Employers in 121 countries/regions across five continents.  "Hovione is a company committed to excellence and differentiation and being a Top Employer is an integral component of Hovione's People Strategy. I am pleased to see that our continuous improvement program, supported by Top Employer´s best practices benchmarks, resulted in our progressing along multiple dimensions at all our locations”, commented Ilda Ventura, Vice-President for Human Resources and Member of the Management Board of Hovione.     Macau Special Administrative Region Douglas Lau, Human Resources Director for Hovione Macau, said that “It is a real achievement to be the first company in Macau to be a Top Employer. This demonstrates that companies in Macau can offer the same high quality workplace environment as anywhere else in the world. Coming so soon after Hovione was awarded the Medal of Merit from the Macau Government, it is also a further demonstration of how Hovione creates jobs that have real value to both our team members and the wider society. Portugal Catarina Tendeiro, HR Senior Director for Hovione Portugal, said that “We are thrilled to announce that Hovione has once again been recognized as Top Employer. This is a confirmation of our ongoing commitment to developing an exceptional workplace environment for our team members, who represent our most significant resource and our company´s main differentiator. I was especially pleased that this year’s report demonstrated improvement in several key areas, including Business and People Strategy, Leadership, Performance and Career and Learning. This demonstrates our desire to listen to feedback and to continue to improve our workplace experience.  USA Erin Tetreault, HR Director for Hovione New Jersey said, “We are thrilled to announce that Hovione has once again been certified as a Top Employer. We believe that our people are our strongest asset and this certification demonstrates our ongoing commitment to create a workplace culture that goes beyond safety and quality and helps all team members to feel truly valued. I was especially pleased that this years’ report showed improvement in several key areas, including Leadership, Work Environment and Employee Wellbeing. This demonstrates our desire to listen to feedback and to continue to improve our workplace experience." Ireland Imelda Cummins, HR Director for Hovione Ireland commented, “We are delighted that Hovione has once again been certified as a Top Employer. Hovione´s team members represent our strongest asset and enable us to offer our customers the high-quality products and services that Hovione is known for. It also shows our ongoing commitment to developing a great workplace environment. I was especially pleased that this year’s report demonstrated improvement in several key areas, including Diversity, Equity & Inclusion, Learning, Sustainability and Career Development. This demonstrates our desire to listen to feedback and to continue to improve our workplace experience.   About Hovione: Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About Top Employers Institute: Top Employers Institute is the global authority on recognising excellence in People Practices. We help accelerate these practices to enrich the world of work. Through the Top Employers Institute Certification Programme, participating companies can be validated, certified, and recognised as an employer of choice. In 2024, Top Employers Institute has certified more than 2300 organisations in 121 countries/regions. These certified Top Employers positively impact the lives of over 12 million employees globally.    

Press Release

Hovione certified as a Top Employer in all of its manufacturing sites

Jan 18, 2024

Pharmaceuticals manufacturer Hovione has been awarded a Medal of Merit for industry and commerce in the government’s 2023 honours list, with Chief Executive Ho Iat Seng praising the company’s contributions to Macao’s emerging life sciences industry. The Portuguese company’s Macao site manager, Eddy Leong, said in a statement that it was a “great honour” to receive the Medal of Merit – which he saw as a tribute to almost 40 years of local work in the science sector. “At Hovione, we like to say that we are ‘in this for life’ and I feel that this award reflects not only our long and successful history in Macao, but also points to our successful future here,” he said.  “It also reflects our commitment to work with partner organisations to create rewarding career opportunities in life sciences,” Leong added. Hovione was founded in 1959 in Portugal and opened its Macao plant in the mid-1980s. The facility produces generic active pharmaceutical ingredients and is located in Taipa, on the site of the old Him Un Iec Kei Chan firecracker factory. Other 2023 honourees include wushu athlete and Asian Games gold medalist Li Yi, who received a Silver Lotus, and the Portuguese-language educator Felizbina Carmelita Gomes – currently director of the D. José da Costa Nunes Kindergarten. Gomes was awarded a Medal of Merit for education.   Read more at Macao News  

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Hovione ‘delighted’ by its Medal of Merit

Dec 27, 2023

22 December, 2023, Hovione is delighted to announce that the Hovione Macau site has been awarded the Medal for Industrial and Commercial Merit by the Government of Macau, a Special Administrative Region of the People´s Republic of China. The site underwent its first of many successful FDA inspections in 1987 and ever since has produced off-patent pharmaceutical actives, which are sold in the global market and boost Macau´s exports. With 180 employees, it is the largest pharmaceutical site in Macau. Over the years, Hovione has worked with a range of governmental departments to support the development of the pharmaceutical industry in Macau. This includes collaborating with the Macau Labor Affairs Bureau to develop the local workforce and create careers in the pharmaceutical industry. Hovione also works with the Education and Youth Development Bureau to organize visits from schools and universities and to arrange internships within the company for students. Team members are also invited by Macau University to give lectures on good manufacturing practice (GMP) and chemical analysis. Eddy Leong, Site Manager of Hovione Macau said: “It is our great honor to receive this Medal of Merit. We would like to express our gratitude to the Macau SAR Government and all sectors of society for recognizing the company's nearly 40 years of presence and industrial activity in Macau. At Hovione, our motto is “In it for life” and this award not only reflects our long and successful history in Macau, but also points to our successful future here. It also reflects our commitment to work with partner organizations to create rewarding career opportunities in life sciences.” The Medals of Merit cover seven categories (Industrial and Commercial, Tourism, Education, Culture, Altruism and Sports). They are intended to reward individuals or organizations that stand out in the exercise of their professional activity.   About Hovione: Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA-inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.  Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Press Release

Hovione awarded prestigious industry medal by Macau Government

Dec 22, 2023

Hovione and Industrial Design Consultancy (IDC) have entered into a joint development of an innovative nasal powder delivery device technology supporting local, systemic, and nose-to-brain drug delivery. Nasal delivery is a simple and safe alternative to conventional delivery routes for drug delivery, which offers a faster onset of action. It is also seen as a promising pathway to deliver new drugs to the brain and treat diseases of the central nervous system. Lisbon, November 29, 2023, Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, just announced an expansion of its nasal drug delivery capabilities with the addition of a family of innovative nasal powder delivery devices developed in partnership with IDC. Intranasal drug delivery is a good alternative to conventional delivery routes for both local and systemic drug delivery due to its simplicity, safety, and faster onset of action. Additionally, it is emerging as a promising pathway to deliver new drugs to the brain to treat diseases of the central nervous system (CNS).  Hovione and IDC have been working together to accelerate the development and commercialization of two new active nasal powder delivery devices, one single-use and one multidose. The devices enable broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. By using standard capsules and filling equipment, they also have the potential to simplify drug product development and manufacturing.  "Intranasal drug delivery is gaining momentum across a number of applications, including mucosal vaccination and CNS treatments bypassing the blood-brain barrier", says Dr. Jean-Luc Herbeaux, Hovione's CEO. He adds: "Our partnership with IDC, a company with vast experience in industrial design, mechanical and electronic engineering of medical devices, enables Hovione to offer a complete solution for nasal powder delivery – covering Active Pharma Ingredients (APIs), formulation, filling, analytics and device design and manufacturing - that address the needs of pharmaceutical companies and patients".  “By combining Hovione’s capabilities in pharmaceutical development, formulation and manufacturing with IDC’s device development expertise, this partnership offers customers a nasal powder delivery solution which can be rapidly adapted to new pharma compounds and therapies” explains IDC´s Managing Director, Dr Stephen Knowles, “Our joint development team has done incredible work to create unique, high performance nasal powder delivery devices.” Hovione will offer the new devices on an exclusive basis as part of its integrated offer for nasal drug development and manufacturing.    About Hovione: Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA-inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.  Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About IDC: IDC is a leading medical product design and development consultancy dedicated to using its creativity, insight, experience and expertise to make the best possible products and deliver commercially successful products for clients and partners.  With over 50 years’ experience and ISO13485 compliant processes and facilities in London and Shanghai, IDC’s experts in user research, design, mechanical and electronics engineering and rapid prototyping work to create award-winning, world-leading products for global markets.    IDC’s track record includes many commercialized drug delivery devices across inhalation, nasal and injectables with a focus not just on design but also ensuring a smooth transition to production and regulatory approvals. IDC’s mission statement is “We innovate to create successful products which improve people’s lives”.  

Press Release

Hovione expands nasal drug delivery capabilities with the development of nasal powder delivery device technology in collaboration with IDC

Nov 29, 2023

Hovione has acquired ExtremoChem Lda, a start-up company with a portfolio of rare sugars, synthetic analogues of the natural molecules found in extremophiles. The acquisition provides Hovione with new high-performance functional materials, which have shown potential in stabilizing biopharmaceuticals. Lisbon, November 16, 2023, Hovione, the specialist integrated CDMO and the leader in spray drying and particle engineering, today announced it has acquired ExtremoChem Lda (ExtremoChem), an innovative start-up company focused on the synthesis, development, and commercialization of bio-inspired synthetic sugars, targeting enhanced stabilization, reduced viscosity and delivery performance of proteins and other biopharmaceuticals.  ExtremoChem developed a library of proprietary sugars, synthetic analogues of natural molecules found in extremophiles – organisms capable of withstanding the most uninhabitable environments. These sugars have shown potential in overcoming challenges associated with the stabilization of biopharmaceuticals during production, purification, formulation, and transportation. Dr. Jean-Luc Herbeaux, Hovione’s CEO commented: "Proteins and other biopharmaceuticals account for a significant share of our customers ´pipelines.  The acquisition of ExtremoChem’s synthetic sugars combined with Hovione's particle engineering capabilities provides our customers with a unique set of tools to optimize formulations that address stability issues encountered during the life cycle of biopharmaceuticals.” Filipe Aguiar, ExtremoChem’s Managing Director commented: “I am delighted that ExtremoChem has been acquired by Hovione. Hovione has a long history of developing and industrializing innovative technologies for the pharma industry. This acquisition will help ensure that the science we developed at ExtremoChem will have a wider and faster market adoption.” The announcement of this acquisition demonstrates Hovione´s commitment to expand its technology platforms. The company is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated development and manufacturing services in drug substance, particle engineering and drug product.   About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA-inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.  Hovione's culture is based on innovation, quality, and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About ExtremoChem ExtremoChem is a chemical synthesis start-up company focused on the development of organic synthetic sugars for the stabilization of biologicals under stress conditions.     

Press Release

Hovione acquires ExtremoChem and its portfolio of proprietary sugars to support customers with stabilization and delivery of biopharmaceuticals

Nov 16, 2023

In the year 2021, when COP26 was held in Glasgow, Sterling Pharma Solutions came out announcing an ambitious target: to reduce the CDMO’s overall emissions by 50% by 2025 and by doing so, joining the international community’s fight against climate change. The CDMO Recipharm expanded its pressurized metered dose inhalers (pMDI) product development the following year to accommodate the switch to new propellants, which have 90% to 99.9% lower global warming potential than HFA134a. In the same year, WuXi STA won top scores from EcoVadis, a provider of business sustainability ratings, for their API and formulations factories located in China. Again, in January, Samsung Biologics was awarded the 2022 Sustainable Markets Initiative’s Terra Carta Seal in recognition of its commitment to achieving net zero greenhouse gas emissions across its direct operations and supply chain by 2050 or earlier. Similarly, Cytiva says its goal is to eliminate polystyrene from the company’s packaging materials and supply chain by 2025. These are just a few examples of a growing trend. A number of CDMOs are accelerating their environmental drive setting themselves far more ambitious targets than these as sustainability goals are now becoming one of the most urgent business strategies facing pharma companies. Presently, analysts say that there is a move away from sustainability being seen as something that is nice to have, to something more fundamentally important to businesses. "Sustainability commitments are no longer just desirable," says Jon Peers, director of sustainability at Hovione. "They are becoming mandatory, both directly by our regulatory authorities and indirectly by the regulatory and financial requirements faced by our customers." Hovione, a leader in spray drying and particle engineering, became a Certified B Corp in 2017 integrating an innovative community of companies that use the power of business to solve social and environmental problems. Pharma’s outsized impact Medicine making leaves an environmental impact which is quite massive. Estimates show that the pharmaceutical sector is accountable for as much as 4.4% of worldwide emissions—and if no action is taken—its carbon dioxide, a greenhouse gas (GHG), emissions are predicted to triple by 2050. Not only manufacturing but the distributing and transporting of medicines from the factory to the patient also carries a substantial environmental footprint. According to the Sustainable Markets Initiative’s (SMI) “Decarbonizing Healthcare Supply Chains” whitepaper, the biopharma industry is responsible for 4–5% of global GHG emissions, with most of its carbon footprint coming from supply chain, manufacturing, retail, and logistics. Having felt the heat, many leading pharma companies are already ahead of the curve on the path to net-zero carbon emissions. They have made carbon neutrality and net-zero pledges, some for as early as the next decade. Sustainability metrics: High on the agenda CDMOs demonstrate a strong determination to reduce their carbon emissions as environmental performance is being added to the list of demands by their clientele. Industry reports show that full waste recycling, green power percentage and green chemistries currently play a crucial role during negotiations between pharmaceutical companies and the CDMOs. These “sustainability metrics” are becoming increasingly important even as technology, track record, capacity, and cost are still the most important criteria for selecting CMOs/CDMOs. "Recognizing our commitment and progress made towards our sustainability targets, clients will seek out not only providers of CDMO services but also those companies with the competence to execute these services in harmony with the client’s respective sustainability goals," says Paul Zuechner, director, sustainability and reliability engineering, pharma services, Thermo Fisher Scientific. Thermo Fisher, which offers end-to-end solutions to small molecules as well as biologics, announced an acceleration of the target to reduce scope 1 and 2 GHG emissions to more than 50% by 2030. Zuechner maintains that the increasing focus on sustainability, resource and decarbonization quantifications is now elevating sustainability towards an equal project deliverable on par with cost, quality, and timelines. The sustainability initiatives by CDMOs are not only driven by customer preference but also by regulatory requirements, according to Peers of Hovione. Regulated and standardized reporting is there. The European Corporate Sustainability Reporting Directive (CSRD) together with the European Sustainability Reporting Standards (ESRS) is significantly raising the required levels of compliance. On top of this, businesses must meet their stakeholder’s requirements to provide material information that stands up to scrutiny. Headquartered in Loures-Portugal, Hovione believes that it is simply not possible to meet the challenging goals that have been set by the companies themselves on sustainability without further innovation, particularly through process intensification and the greening of pharmaceutical intermediate and API manufacturing. Safety via process efficiency Without question, manufacturers are aggressively pursuing various strategies to enhance processes as it becomes a business imperative for the service providers. "Olon tries to optimize plants' performances, in order to reduce the amount of energy, materials and natural resources they need,'' says Giorgio Bertolini, senior vice president of R&D, Olon Group, a global leader in the development and production of APIs, headquartered in Milan, Italy. Olon is working on cutting-edge R&D processes applied both to chemistry, in terms of flow chemistry, photochemistry, and electrochemistry, and to biotechnologies. Investing in and developing technological advances allows the organization to combine well-established practices with new ones, to guarantee efficient and successful manufacturing processes, at the same time ensuring safe, fast and cost-effective commercial processes. "We consider climate protection and the related reduction of GHG emissions to be a top priority," emphasizes Bertolini. To increase efficiency and reduce the energy required for production, especially in the functioning of reactors, Olon is implementing several continuous manufacturing processes, investigating both the flow chemistry approach and the continuous stirred tank reactors (CSTR) These approaches entail leaving no batch reactors with loading and unloading phases but keeping constantly active production units—either microreactors or small classical reactors. The outcome is that, at the same levels of production, continuous manufacturing processes can reduce the footprint of the manufacturing process in comparison with standard methods. This innovative production technique, he explains, enables a double positive impact in terms of sustainability. Indeed, it allows for the use of smaller amounts of material for the unit time, therefore resulting in increased local temperature control and in the possibility to avoid extreme temperatures, making the manufacturing process less energy intensive. It also provides greater safety for operators. The industry is now facing a change of paradigm, avers Bertolini, in which there is a continuous exchange of knowledge and information between the chemical and engineering sectors, which eventually results in the creation of new specific know-how and business synergies. Olon started constructing a new facility at its Rodano site (Milan, Italy) dedicated to ultra-potent compounds, used for antibody-drug conjugates (ADCs). Circular business models that combine a responsible use of natural resources and raw materials with a responsible waste management approach are what Olon strives to promote, according to Bertolini. Greening the supply chain To reduce effluents and design safer alternatives to hazardous processes organizations extensively explore the use of safer and more sustainable chemicals. This green chemistry approach can minimize the risk of impact on the environment to a great extent. Olon, for instance, is focusing on green chemistry projects for the replacement of chlorinated solvents and the reduction of critical substances which could be particularly toxic, especially in new manufacturing processes. Not only in manufacturing, quite a few companies are investing in greener biofuels (rather than diesel) for vehicles. As mentioned, distributing and transporting medicines from the factory to the patient also leaves a large carbon footprint. Temperature-sensitive products are loaded onto refrigerated vehicles to maintain cold-chain which require a considerable amount of energy to power. Environmental credentials are now integral to all supply chain decisions. There is almost a universal consensus on this approach, shows the CPHI sustainability sentiment index. In data released ahead of CPHI Frankfurt 2022, 95% of industry executives suggest it is either “important” or “extremely important” (52%) to have visibility on supply chain partners. Scope 3 emissions: Key challenge In comparison to the scope 3 tally that falls not within the organization's boundary, scopes 1 and 2 emissions are relatively minor. However, within these scopes, electrical energy consumption in manufacturing and the fugitive emissions from hydrofluorocarbons (HFC) released during pMDIs product lab testing are the highest. pMDIs and anesthetic gases can be particularly serious for global warming. The UK and several countries in the EU block including Belgium, and the Netherlands are now promoting dry powder inhalers in prescription guidelines. Meanwhile, the common general anesthetic desflurane is being replaced by lower-carbon alternatives in countries like Sweden. Scope 3 emissions, however, make up the majority of the pharma sector’s carbon footprint. Even though many CDMOs have set ambitious targets like striving for carbon neutrality across the entire value chain already by 2030, many are still simply focusing on scope 1 and 2 emissions. Observers say that this is largely because the need for sustainability in the pharmaceutical industry has become more apparent only in recent years. Another concern is the cost factor. According to Peers of Hovione, decarbonization costs in particular can be very expensive and require strategic planning and commitment from senior management to meet associated capital and operational costs. The sustainability challenge, he says, needs to be considered throughout the drug development life cycle, starting from simple assessments against sustainability principles and metrics early on and growing in detail and robustness as the drug progresses through the cycle. Shift in focus Experts, however, see a shift across the industry. Discussions about sustainability are taking place at the highest levels. An increasing number of pharmaceutical companies are prioritizing it when discussing projects with their CDMO partners. "Be it the fulfillment of new technical capabilities, increased production capacities, advancing regulatory compliance and now sustainability target introductions—it’s natural for us to solve for and achieve our customers’ product development, manufacturing, and corporate goals in partnership,” says Zuechner of Waltham, Massachusetts-headquartered Thermo Fisher. It will be essential for drug makers and their CDMO partners to work together on questions of sustainability, and to be ready with a sustainability agenda before starting to work on the project, in the coming years. It is important for CDMOs, says Peers, that their clients and suppliers share the same vision of a more sustainable industry as collaboration across the value chain is key to leveraging knowledge and driving change.   Read the article at contractpharma.com  

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Net-Zero Pledge: CDMOs Go Greener

Jul 19, 2023

Responsible for 39% of the nation’s total annual exports, the Irish pharmaceutical sector continues to expand its capabilities   Ireland’s life sciences sector is internationally renowned for its operational and innovational excellence, with 19 out of the top-20 global pharmaceutical and biopharmaceutical giants having a presence in the country. Overall, more than 85 pharmaceutical companies are currently operating in Ireland and the sector employs over 42,500 people. And this talent base is constantly expanding, thanks to continuous new investment into the sector. “We are the world’s third-largest exporter of pharmaceuticals and we have a good reputation for strong regulatory compliance and quality. Our regulators are seen around the world as some of the leading lights in setting standards. As a result, pharmaceutical companies in Ireland go beyond compliance, which gives them a competitive advantage,” says Paul Downing, general manager of Hovione, the leading international contract development and manufacturing organization (CDMO) that specializes in fully integrated innovative services for drug products, product intermediates and substances.    PAUL DOWNING GENERAL MANAGER, HOVIONE “Pharmaceutical companies in Ireland go beyond compliance, which gives them a competitive advantage.”   With state-of-the-art manufacturing facilities in Ireland, the US, Portugal and China — all of which have high regulatory compliance — Hovione has a global employee base of nearly 2,500 people and in its 63-year history has had more than 41 regulatory inspections from authorities such as the US Food and Drug Administration with no product recalls and no warning letters being issued. Something that Downing is exceptionally proud of. “We’re an expert organization with capabilities in technology transfer and new product introductions and, from a CDMO perspective, we’re recognized as a world leader in spray drying,” he says. “We’re also a progressive company and we go above and beyond compliance; we always want to learn and give our customers more, because customer satisfaction is at the heart of everything we do.” Hovione began its operations in Cork in 2009. Since then, it has quadrupled its Irish assets, client base, sales and employees, which has given it the right ecosystem to take on large customer projects. As with any industry, the digital revolution is changing all facets of the pharmaceutical business and Hovione itself has implemented a host of new digital tools at its Irish facilities in recent years. “One example of this is an electronic laboratory notebook, which is a digitalization of our core activities in research and development and our quality control laboratories. That has driven efficiency and standardization,” says Downing. “As a company, we have other global initiatives, including a plant data management system, which is a central hub for all our data on trends and information that allows us to analyze and share that data. “In addition, we’ve started to adopt a manufacturing execution system and are automating electronic batch records. That’s the journey we’re on. Here in Ireland, there are lots of advocates for industry 5.0. We’re watching that brief to see how it evolves and whether we can tap into that as well.”   Future growth of the biopharma industry Ireland’s pharmceutical sector began to become an international presence in the 1960s after the arrival of pharma giant Pfizer, which was followed by names like Merck, MSD, SmithKline, GSK, Eli Lilly, Bristol Myers Squibb, Alexion and Regeneron — and by 2021, the sector was generating over $85 billion a year from its exports. Investments continue to flood in to the tune of around $1-$2 billion annually, and this could soon increase, as the association that represents Ireland’s biopharma and chemical industry, BioPharmaChem Ireland —part of the wider trade body Ibec — has recently launched a five-year strategy to further develop the sector.    "We’re prioritizing skills and talent,” outlines Matt Moran, director of BioPharmaChem Ireland. “For example, we have established an apprenticeship program, which we work on with the government, that is non-traditional and vocational. In the past, companies would normally have employed university graduates, but now there is an opportunity for school leavers to work in the industry and acquire qualifications at the same time. We also operate an industry-led Skillnet training initiative, through which we arrange for training programs to be delivered to the industry to fill skill gaps. The association is also prioritizing the continued growth and competitiveness of all the sub sectors of the industry, including active pharmaceutical ingredients, biotech and finished products, states Moran, who adds: “Some of the newer areas we’re exploring at the moment are pharma 5.0, which involves empowering employees as well as deploying technology, sustainability in manufacturing, cell and gene therapies and very advanced therapeutics. We also want to grow our indigenous base of startups and to expand our footprint to include additional aspects of the industry, such as global business services, clinical research and more engagement research. That’s the future.”   Read the full article at BusinessFocus.org    

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Excellence in pharmaceuticals

Jun 30, 2023

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