将一个生物药推向临床或市场是一个复杂而庞大的工程，并非任何一家创新公司都能轻易拥有所有技术平台， 并配备相应的设施设备、专业人员、运营能力和管理技能等。幸运的是，现在可以通过寻找外部资源使这些变 得触手可及。苏州智享可为您提供从细胞株开发到最终成品供应的各步骤独立服务或端到端一体化解决方案。
To push a biologic into clinic or market is really a complex and huge project, it is not easy for any innovative company to assemble a complete set of technology platforms with facilities and equipment, professional staff, operational capabilities, as well as management skills. Fortunately, looking for external expertise makes “all of the above” within touch easily. At IntellectiveBio, we offer both standalone services and integrated solutions from cell line development to finished product supply.
我们深刻体会，您在这场激烈的竞赛中所面临的每一个里程碑压力，如提交IND或BLA。我们的专家会时刻倾听您的意见，与您并肩合作，找到满足您项目需求的最佳解决方案，更快为患者提供有质量保障的救命药。
We deeply understand the pressure, in the extremely competitive race, to meet each important milestone, such as filing the IND or BLA. Our experts listen and collaborate with you to find the best solution to fit your project needs, helping you bring lifesaving drugs to patients quickly and reliably.
我们的专家为那些希望以最快速度把一个生物药推进至首次人体试验的研究者设计了一套高度集成的开发方案。只要15个月，我们不仅可以为您提供已经过放行检测的生物制剂，以便您随时开展一期安全性评临床试验，还可以为您准备好IND申报所需要的一整套药学开发资料，包括3个月的稳定性数据。这套为大分子量身定制的解决方案包括：
Our ‘Quick to First-in-Human’ solution is a highly integrated development suite which is designed specifically for those looking for the shortest time cost to deliver a biologic to First-in-Human trial. In as little as 15 months, you can have your released biologic drug product ready for your Phase I safety testing and all the data you need, including 3 months of stability data, to complete your IND filing. This tailored solution for large molecules comprises:
-
细胞株开发与检定 Cell line development and characterization
-
上下游工艺开发 Upstream and downstream processes development
-
水针制剂处方开发 Liquid-filled vial drug product formulation development
-
放行和表征方法开发 Analytical methods for both release testing and characterization
-
早期毒理研究样品制备 Sample preparation for early toxicology studies
-
GMP原液生产与放行 Released GMP drug substance
-
GMP制剂生产与放行 Released GMP drug product
-
病毒清除实验 Viral clearance testing
-
三个月稳定性研究数据 Stability study data for 3 months
-
CTD格式的CMC申报资料 CMC documentation in CTD format
在临床研究的后期阶段，作为BLA申报的一部分，我们可为您提供一整套基于法规要求和cGMP指南的工艺表征与验证服务。这个集成包包括：
At the later stage of clinical studies, as part of the establishment of your BLA submission, we offer a full-integrated package for process characterization and validation based on regulatory and cGMP guidelines. This package comprises:
-
工艺参数风险评估 Risk assessment of process parameters
-
缩小模型建立 Scale-down model establishment
-
关键工艺参数范围研究 Design space study on critical process parameters
-
下游工艺病毒清除验证 Virus clearance validation of the downstream process
-
填料寿命研究 Resin re-use study
-
纯化中间品稳定性研究 In-process hold time studies
-
杂质挑战研究 Impurity challenge studies
-
材料相容性研究Material compatibility studies
-
分析方法验证 Validation of analytical methods
-
工艺验证整合控制策略 Process validation with integrated control strategy
-
验证批生产 Validation batches manufacturing
-
放行检测 Release testing
-
ICH稳定性研究 ICH stability studies
-
CTD格式的CMC申报资料 CMC documentation in CTD format