Press Room

Press Release / Sep 29, 2009

Successful FDA inspection at Hovione’s API manufacturing plant in Loures, Portugal

Loures, Portugal, September 29th, 2009 – Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA.

The inspection, carried out by Mr. Mark Parmon, Inspector of Cincinnati District lasted 5 days as initially planned, starting on 21st September and concluded on the 25th, covering 5 ANDAs and 1 NDA. No Form 483 was issued. At the closing meeting the inspector informed that he was happy with what he had seen and congratulated our GMP System and the knowledge of team members.

Luisa Paulo, Hovione's Compliance Director, said "The inspection focused on the documentation system, especially on how we record and manage OOS, deviations, change control, batch production records and analytical procedures. The Inspector focused on looking for deviations in consistency of the application of procedures”. Hovione plants have been the object of 17 FDA inspections, with 10 at the Loures site since 1982. The thoroughness of inspections and the ability to make an assessment of the maturity of GMP system is far greater than before. The main objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed in day-to-day plant operations. Special emphasis was given to: 1) root cause determination; 2) preventive and corrective actions implementation and follow-up; 3) impact analysis of the changes and 4) production and analytical operation. The Loures plant has a total workforce of about 500 professionals and produces both generic products, as well as APIs and bulk formulated products manufactured under exclusivity for both clinical trials and for commercial sale. The facility exports to the most demanding markets such as North America, EU, Japan and Australia. About Hovione. Hovione is an international company with 50 years’ experience in active pharmaceutical ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers in the most highly regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area Hovione is the only independent company offering such a broad range of services.

For more information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications, Isabel Pina, + 351 21 982 9362, e-mail: mailto:hello@hovione.com.

 

 

Also in the Press Room

See All

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.  

News
News release, 09 May 2024

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

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!  

News
Place your vote.

Hovione nominated in HR Awards – voting is open globally

May 03, 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
GMP Journal, 04 March 2024

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024

Also in Events

See All