Press Room

Press Release / Nov 11, 2004

FDA inspects Hovione's API manufacturing plant in Macau

Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA

Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA; this was triggered by a filing by a US customer. The inspection, carried out by Ms. Karen Moksnes, Compliance Officer at the U.S. FDA Center for Drug Evaluation and Research (CDER) and by Ms. Susan Ting, Chemist at the U.S. FDA Office of Regulatory Affairs (ORA), lasted 3 days, and resulted in a Form 483 with two minor points. Mr. Luis Gomes, General Manager of the plant, said "the inspection was concluded one day early, and by the closing meeting the two points had been satisfactorily addressed".

Hovione plants have been the object of 13 FDA inspections, with 5 at the Macau site since it started to operate in 1986. This inspection reflected the "Risk-Based Management Plan" described in its Pharmaceutical Quality for the 21st Century: The emphasis is on the design and operation of the quality system and on the competence and understanding of the operators and analysts. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective is to be able to determine the plants', and the plant management's, "credibility and reliability" rating that is used in FDA's Risk-Based calculations.

The Macau plant has today a total workforce of 133 professionals and produces both Hovione catalogue generic products and commercial APIs manufactured under exclusivity and has been increasingly used by Hovione customers to produce on an exclusive basis clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for one third of Hovione’s total production, and exports to the most demanding markets such as the USA, EU, and Australia.

 

About Hovione
Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and eAPIs for the Pharmaceutical Industry. With a 40-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery.

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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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We are proud to have been nominated in three categories for HR Magazine’s annual awards, for Team Spirit and Engagement, Internal Mobility and Best HR Director. At Hovione, we talk about "Team Members” rather than “employees”, emphasizing the company's commitment to fostering a culture where teamwork is not just valued but integral to achieving collective success. We believe that individuals work best when they feel supported and are working towards a shared goal.  Hovione is a global company with a diverse range of roles across different disciplines. This means that we can offer team members the opportunity to explore new horizons and expand their skill sets within the company, enriching their career experiences and driving innovation across the organization. The awards are decided by a public vote which is open until the 17 May. Vote here!  

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Hovione nominated in HR Awards – voting is open globally

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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  

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Continuous Tableting and the Road to Global Adoption

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