Recipharm reports that a new modular sterile filling system specifically tailored for process development, pilot scale, and clinical supply, is now fully operational at its facility in Wasserburg, Germany.

Recipharm报告称，一种专门为工艺开发、中试规模和临床供应量身定制的新型模块化无菌灌装系统现已在其位于德国瓦塞堡的工厂全面运行。

The company says this system performs aseptic filling within a Grade A isolator and operates in full compliance with GMP standards and offers flexibility, featuring interchangeable modules that support various product types, such as syringes and vials. An additional pre-filled syringe (PFS) module is being added to the installation..

该公司表示，该系统在a级隔离器内进行无菌灌装，完全符合GMP标准，并具有灵活性，具有支持各种产品类型（如注射器和小瓶）的可互换模块。安装中增加了一个额外的预充注射器（PFS）模块。。

The line can deliver 500 to 50,000 units per batch, covering all the development phases of a product, notes Gregor Kawaletz, COO, Recipharm, who adds that the system provides great efficiencies and cost saving, by limiting the loss of high value products to less than 500mL and preserving material for clinical trials..

Recipharm首席运营官Gregor Kawaletz指出，该生产线每批可交付500至50000单位，涵盖产品的所有开发阶段，他补充说，该系统通过将高价值产品的损失限制在500mL以下并保存用于临床试验的材料，提供了极大的效率和成本节约。。

This new unit complements Recipharm’s existing development and commercial filling capabilities. Unlike traditional large-scale production systems, the unit is optimized for small-batch production, offering a flexible solution for clinical development projects across rare disease pharmaceuticals, cell and gene therapies, and other advanced and emerging modalities with highly focused patient populations, continues Kawaletz..

这一新装置补充了Recipharm现有的开发和商业灌装能力。。。

This also makes it a companion to ReciBioPharm’s Biologics and ATMP services and, when used with Recipharm’s ReciPredict, the product benefits from optimized time and cost efficiency, supporting a seamless tech transfer to commercial production, according to Kawaletz.

据卡瓦莱茨介绍，这也使其成为ReciBioPharm生物制品和ATMP服务的伴侣，当与Recipharm的ReciPredict一起使用时，该产品受益于优化的时间和成本效率，支持无缝技术转移到商业生产。

“With this unit, we offer our clients a flexible, high-quality, and GMP-compliant solution for their development and clinical production needs. This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development,” he says..

他说：“有了这个部门，我们为客户的开发和临床生产需求提供了一个灵活、高质量和符合GMP的解决方案。这个安装反映了我们对投资创新技术的承诺，这些技术可以实现更快、更高效的药物开发。”。。

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