合同生产
Contract Manufacturing

生物药市场正在飞速发展，我们十分了解日益增长的生物制药合同生产需求。世界级的生产设施、行业领先的技术知识，这些其实都可以通过外部获得。苏州智享可为客户提供符合cGMP标准的原料药和制剂成品的端到端、全集成的商业化生产服务。我们不断地改进基础设施，升级产能和技术，致力于以卓越的质量、经济的成本，以及灵活的变化适应性，年复一年地赢得您的业务。

The biologics market is experiencing high growth. At IntellectiveBio, we understand the increasingly contract manufacturing requirements for biological drugs and also world-class facilities, industry-leading expertise that can be employed. We can provide our clients end-to-end, fully integrated commercial manufacturing services for both drug substances and drug products under full cGMP conditions. We are continuously making improvements in capacity, infrastructure and technology, and dedicated to earn your business year after year with exceptional quality and effective cost, plus flexibility to adapt to changes in your market.

我们的优势:
Our Advantages:
  • 丰富的生物制药生产经验

    Rich biopharmaceutical manufacturing experience

  • 有效的质量控制与保证

    Valid quality control and assurance

  • 严格的法规依从性

    Strong regulatory compliance

  • 卓越的记录追踪

    Superior track record

  • 专业的技术转移与工艺放大

    Technology transfer and process scale-up expertise

  • 稳定的供应商合作

    Stable supplier partnership

服务范围:
Our Capabilities:
GMP细胞库：
GMP Cell Bank：

苏州智享严格按照ICH Q5和产品申报地区法规要求制备和管理细胞库，采用C+A或B+A 环境进行细胞库的制备。细胞库实行严格的权限控制和出入库管理，保护客户知识产权的同时，确保满足法规符合性要求。

IntellectiveBio prepares cell banks in grade C+A or grade B + A area, in accordance with ICH Q5 and other related laws and regulations. The storage rooms for cell banks implements strict access control and incoming/outgoing management, which help protecting the intellectual property rights of our clients while ensuring regulatory compliance at the same time.

原液：
Drug Substance：

苏州智享原液生产所使用的核心设备均为进口高端品牌，上游拥有GE的200L、500L、2000L一次性抛弃型反应器，下游有GE层析系统、Millipore过滤系统，可为客户提供不同项目阶段、不同质量要求的生产服务。

At IntellectiveBio, the core equipment used for drug substance production are all from global-leading suppliers. The upstream is equipped with GE 200L, 500L, and 2000L disposable bioreactors, and the downstream is equipped with GE chromatography systems and Millipore filtration systems. We can offer manufacturing services with different quality needs and at different stages of the project.

制剂：
Drug Product：

苏州智享制剂生产采用进口Waston-Marlow灌装线，Tofflon冻干机和自动进出料系统，与产品直接接触的部分均采用一次性耗材，具备小容量注射剂和无菌冻干制剂的生产能力。

IntellectiveBio drug product production utilizes imported Watson-Marlow filling line, Tofflon lyophilization machine and automatic feeding/discharging system. The parts which may directly contact the product all use disposable consumables. We have the ability to produce small-volume injections and sterile lyophilized vails.