Press Room

News / May 11, 2017

Bioconnect Seminar at the Hovione Cork Site

The Hovione site welcomed close to 50 people from the Irish Pharma, Biotech and University sectors for a combined seminar with Bioconnect Ireland on the theme of Tech Transfer in the pharmaceutical industry.

Bioconnect Seminar at the Hovione Cork Site | Hovione

Paul Downing, General Manager of Hovione Cork, gave the opening address and introduced Jim Ryan CEO of Bioconnect Ireland who chaired the meeting. First on the Podium was Brian Harrison who previously held many management positions in Bristol-Myers-Squibb and now Managing Director of his own start-up outfit. He gave an overview of the Tech transfer process and the importance of aligning the same mindset on both the receiving site and transfer site. This followed by two of our own guest speakers Rui Loureiro and Márcio Temtem both of whom gave complementary presentations on techniques to overcome solubility issues and effective use of modeling to have a robust process for scale-up. The presentations were varied in their themes from Biotech start-ups to mainstream pharma distribution companies. An interesting QA session was followed by a group photo in front of Building 10. Paul Dunne European, Business Development Manager, presided over the wrap up before the site tour. The evening concluded with a networking and drinks reception in the China room.

Bioconnect Seminar at the Cork Site | Hovione

 

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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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