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.
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.
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:
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: