Press Room

Press Clipping / May 29, 2018

The good times keep rolling in pharmaceutical chemicals

C&EN, May 21, 2018

Rick Mullin interviews Frédéric Kahn at CPhI North America.

 

frederic-kahn-photo

Frédéric Kahn

VP Sales and Marketing

Degree in Economics, MBA

 

 

 

Hovione, which has likewise added services, including spray drying and finished-dose form manufacturing, in the past two years, continues to invest both at its headquarters in Loures, Portugal, and at its technology center in East Windsor, N.J.

The company spent about $100 million in 2017 and plans to invest as much again this year and next, according to Vice President for Sales and Marketing Frédéric Kahn. Hovione opened a 7,000-m2 development services center at its main manufacturing facility in Loures, equipped to handle highly potent compounds. With 200 people hired over the past three years, the site now employs a staff of 1,600. Hovione may hire another 200, Kahn said.

In New Jersey, the company is in the process of doubling chemistry and analytical service capacity and will begin operating a continuous tableting facility this month.

Kahn says Hovione is interested in offering one-site shopping in Portugal and New Jersey.
The plan over the next three years is to continue investment, especially in Portugal, Kahn said, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m3 analytical lab.

“This is capacity that we are going to have to sell,” Kahn acknowledged, “but we pursued it by listening to our customers—by understanding what their requirements are in terms of API, formulation, solubility enhancements, and continuous tableting.”

Kahn declined to call the added services a push toward the one-stop-shop model. Rather, he said, the firm will now offer one-site, full-supply-chain service in both Portugal and New Jersey.

 

Read the entire article

 

 

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