Press Room

Press Release / Oct 17, 2018

Hovione increases production capacity

‘One Site Shop’ expands to respond to growing demands

Loures, Portugal, October 17, 2018 – Hovione announces plan to increase production capacity in oral dosage forms in Portugal, to strengthen the integrated offering. New commercial scale equipment for blending, tableting and coating will complement existing development small scale equipment. This decision to expand follows growing customer demand since, one year ago Hovione started offering end-to-end solutions, from drug substance to drug product, from the Loures site.

As a specialist integrated CDMO, Hovione is increasingly being chosen as a solution partner from Drug Substance to Drug Product. Hovione ‘One Site Shop’ allows customers to streamline their supply chain, reduce time to market and benefit from seamless project management. This increase in capacity will help Hovione customers to consistently bring products faster to market.

“Hovione has a unique value proposition when it comes to processing amorphous solid dispersions. Our Company has more than 15 years of experience in pharmaceutical spray drying and has produced hundreds of batches for clinical trials and commercial supplies.  Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value added services they expect from us. They want to keep their product in the same capable hands. This investment shows our commitment to listen to our customers and continue to support their evolving needs,” says Frédéric Kahn Vice-President of Marketing & Sales at Hovione.

In parallel Hovione will be completing by the end of 2018, the qualification of its continuous tableting line at Hovione New Jersey, which will enable the site to offer end-to-end solutions for US customers that are keen to keep their supply chain local.

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, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. Globally within our R&D we added new labs, new drug product centres, pilot plants and our state-of-the-art particle engineering technologies both in the US and in PT. Locally, the Loures site expanded its drug substance reaction vessel capacity with a small-scale production area and a new pilot plant. We also installed more spray drying capacity at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. In New Jersey, Hovione doubled the size of its development and manufacturing operations. In Cork we also expanded our chemical synthesis capacity devoted to contract manufacturing.

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 customers’ demands whenever necessary. At Hovione, we want to be the CDMO that customers like the most, therefore we put the customers’ needs at the centre of everything we do relying on three growth pillars: operational excellence, customer centricity and the team members’ engagement.

 

About Hovione
Hovione has almost 60 years of experience as a Specialist Integrated CDMO offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, Macau, Ireland, 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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