Press Room

Press Clipping / Dec 10, 2018

Expansion at Hovione Ireland

Irish Pharma Chem, Industry Buyers Guide, December, 2018

Hovione Loughbeg supplies medium and large-scale manufacturing active pharmaceutical and drug product intermediates that are approved by European, US and Asian health authorities. Over the last four years, the site has continued to successfully transfer new products, acquire new business, achieve multiple regulatory approvals and attract key talent to the site, which now boasts close to 200 team members.

Adding Capacity

In May 2018, Hovione concluded the re-instatement of a second active pharmaceutical ingredient building on the site, adding further significant capacity, technical capability and expansion opportunities. This promising expansion creates career development opportunities for existing and new team members. 
The site now has all three production buildings in operation for the first time in its history. This major investment in the Loughbeg facility will enable further diversity in the product portfolio and brings major additional capacity to the Hovione group, providing enhanced flexibility and agility to both existing and future customers. “We at Hovione Ireland are looking forward to celebrating our 10th year of operation in 2019,” explains Paul Downing, Hovione Ireland General Manager, “which is also the 60th anniversary of the founding of the company in Portugal.”

In It For Life

“Hovione is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market,” Downing explains. “We do well what is difficult, to give our customers what they cannot find elsewhere.”

Also in the Press Room

See All

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