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European Pharmaceutical Manufacturer·· 5 小时前AI 评分32

Ardena 在比利时根特总部投资 Korsch Styl'One Evo 压片模拟器

Ardena invests in new compaction simulator

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Ardena 宣布投资新型压片模拟器 Korsch Styl'One Evo,以增强其片剂开发能力并加快生产时间线。该平台可模拟旋转压片机的压缩曲线,用少量物料获取粉末机械与压缩特性及放大参数,已安装于其比利时根特总部。根特基地有逾100名员工,同时设有 CMC 法规团队。

正文 · 原文

Ardena, a pharmaceutical CDMO and bioanalytical CRO enabling precision medicines and complex therapies, has announced it has invested in a new compaction simulator to enhance its tableting development capabilities and accelerate manufacturing timelines.

The new technology platform, a Korsch Styl’One Evo, can mimic the compression profile of a rotary press, and using small volumes of material can gain information on powders’ mechanical and compaction characteristics and scale up parameters, saving time and valuable drug product to advance candidates towards clinical development phases. It has been installed in Ardena’s headquarters in Ghent, Belgium, which serves as the company’s hub for solid dose drug development. Projects will be able to be rapidly advanced using the technology platform, before being scaled up at one of its global manufacturing sites.

“Drug development is under constant pressure to be accelerated and use less material in research to maximise efficiency, and the investment in this technology will allow us to rapidly screen manufacturing processes in tableting and generate a wealth of information using small quantities of drug product,” commented Ian Bilodeau, global head CDMO at Ardena. “Oral solid dosing is still seen as a primary choice for drug developers, and by having access to this technology gives us the opportunity to optimise processes and advance projects into the clinic as rapidly as possible.”

Ardena’s Ghent facility has over 100 employees, and as well as being the company’s headquarters and hub for drug development, houses the company’s CMC Regulatory team, which provides specialist expertise and tailored services to support customers from pre-clinical to clinical manufacturing.

来源:European Pharmaceutical Manufacturer · pharmaceuticalmanufacturer.media