「英中对照」Germfree推出细胞基因治疗制造用洁净室无菌隔离器 预计2027年一季度商用

Germfree has launched a new aseptic biopharmaceutical isolator designed for cell and gene therapy (CGT) manufacturing, with commercial availability expected in the first quarter of 2027.Germfree推出了一款专为细胞与基因治疗（CGT）生产设计的新型无菌生物制药隔离器，预计将于2027年第一季度上市。

Manufactured at the company's facility in Ormond Beach, Florida, the isolator is designed to provide a Grade A processing environment within Grade D or higher cleanrooms, supporting contamination control during open manufacturing steps.该隔离器在公司位于佛罗里达州奥蒙德比奇的工厂制造，旨在D级或更高级别洁净室内提供A级处理环境，为开放式生产步骤中的污染控制提供支持。

The system features a fully welded 316 stainless-steel construction designed to withstand frequent cleaning and decontamination. 该系统采用全焊接316不锈钢结构，可承受频繁清洁和去污。 

Configurable shelving, racks and penetration locations allow it to be adapted to different manufacturing workflows.可配置搁架、支架和贯穿件位置使其能够适应不同的生产工作流程。

A large material air lock (MAL) with a configurable sliding rack system supports material transfers, while automated leak testing and onboard vaporised hydrogen peroxide (VHP) decontamination are designed to support aseptic processing requirements.配备可配置滑动架系统的大型物料气锁（MAL）支持物料转移，而自动检漏和内置汽化过氧化氢（VHP）去污功能旨在满足无菌处理要求。

Germfree said the platform was developed in response to customer demand for an alternative to bespoke isolators and standard off-the-shelf equipment, combining configurable features with a standardised design.Germfree表示，该平台是应客户需求开发的，作为定制隔离器和标准现成设备的替代方案，将可配置功能与标准化设计相结合。

The isolator is intended for applications including small-scale processing, quality control (QC) workflows and semi-automated benchtop or manual filling operations.该隔离器适用于小规模处理、质量控制（QC）工作流程以及半自动化台式或手动灌装操作等应用。

It is designed to fit into cleanroom spaces with ceilings as low as eight feet and standard 36-inch-wide doors without disassembly, which the company said could simplify installation and reduce downtime during commissioning and qualification.其设计使其无需拆卸即可装入天花板低至8英尺、采用标准36英寸宽门的洁净室空间，公司称这可简化安装并减少调试和确认期间的停机时间。

“This product line reflects Germfree’s growth as a total solutions company, building not just your cleanroom but every critical environment you need for your process,” said Forrest Brown, Chief Strategy and Services Officer at Germfree. “此产品线反映了Germfree作为整体解决方案公司的成长，不仅建造您的洁净室，还建造您工艺所需的每一个关键环境，”Germfree首席战略与服务官Forrest Brown表示。 

The isolator will be manufactured and serviced in the US, with Germfree providing a US-based team of commissioning, qualification and validation (CQV) specialists and service technicians.该隔离器将在美国制造并提供服务，Germfree将提供驻地美国的调试、确认与验证（CQV）专家和服务技术人员团队。

The company said the system is particularly suited to patient-derived cell therapies, where individual manufacturing batches may represent a single patient's dose. 公司表示，该系统特别适用于患者来源细胞疗法，在这类疗法中，单个生产批次可能对应单名患者的剂量。 

Its configurable design is intended to accommodate developers as they progress from clinical trials towards commercial manufacturing.其可配置设计旨在适应开发商从临床试验走向商业化生产的发展过程。

The launch follows other developments at Germfree as the company expands its aseptic processing and cleanroom technology offering.此次发布之前，Germfree在扩大其无菌处理与洁净室技术产品组合方面已有其他进展。

In August, Germfree partnered with Nuvai Medical Technologies to integrate AI-powered aseptic technique monitoring into its Smarthood IV compounding system, enabling real-time monitoring of sterile medication preparation practices.
 8月，Germfree与Nuvai Medical Technologies合作，将AI驱动的无菌操作监测集成到其Smarthood IV调配系统中，实现对无菌药品调配操作的实时监测。
 

In March, Germfree appointed Carol Houts as CEO to lead its next phase of growth in modular cleanroom solutions and advanced therapy medicinal product (ATMP) manufacturing infrastructure.3月，Germfree任命Carol Houts为CEO，领导其在模块化洁净室解决方案和先进疗法药品（ATMP）生产基础设施领域的下一阶段增长。