Press Room

Press Release / Mar 19, 2018

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

Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey.

Loures, Portugal, March 19, 2018 – Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey, with the aim to: increase capacity in existing technologies, like spray drying and grow in new areas of business to support its clients demand.

The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fifteen minutes away from the Loures manufacturing site, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas.

In this period, Loures site expanded its drug substance reaction vessel capacity with a small scale production area and a new pilot plant, totalling additional 30 m3 of capacity. In addition, one pilot and two large scale spray dryers were installed at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities.

During the same time, Hovione doubled the size of its development and manufacturing operations in the New Jersey site, providing it with a full range of capabilities, from chemical & analytical development, through spray drying to formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large scale spray dryer and a continuous tableting unit.

In the Cork site, Hovione is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing.  About half of this capacity will be ready for operation by May 2018.

Over the next three years Hovione will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total area of 4,200 m2 for 165m3 of reaction vessel capacity and two large spray drying units, new formulation facilities that will enable the production of bigger batch sizes and a new building that will host additional 1200 m2 of analytical laboratories.

This investment effort is being paired with recruiting and training new staff clearly illustrated by a 39% headcount growth in the last 2 years.

 “This addition in capacity expansion will secure our growth and ensure that we continue to provide a truly integrated full-service solution to our customers, as well as showing Hovione’s strategy and commitment to further strengthen its global market leadership in Spray Drying” said Frédéric Kahn, Vice-President Marketing & Sales.

“This capacity expansion plan is far more than a matter of production capacity solely. It aims to reorganize sites with new buildings, renew existing facilities and give operations the most advanced equipment in the market, to provide our customers and team members with the technology and the capacity they need to grow in a sustainable way. It is a significant effort and commitment from Hovione to stay ahead of and prepare for future demand.” said Nuno Almeida, Vice-President of Engineering.

 

About Hovione
Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the USChinaIreland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

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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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