质控体系

产业智造基地

Industrial Nucleus

厦门生物医药产业园布局研发中心与临床级科研生产基地,打造细胞技术产业化核心引擎。

R&D and clinical-scale production facilities in Xiamen Biomedical Park powering cell technology industrialization.

 

全链质控认证

Certified Quality Fortress

GMP细胞实验室 (B+A洁净认证)  + ISO三体系认证,筑就全链质控堡垒。

GMP cell labs (Grade B+A) + ISO triple certifications enabling end-to-end quality sovereignty.

 

临床转化加速

Clinical Translation Engine

联合三甲医院推进IIT研究,提速TSY全管线IND进程。

Accelerating TSY IND-enabling studies via IIT collaborations with top-tier hospitals.

 

多元产能矩阵

Scalable Technology Matrix

干细胞平台/百万级外泌体产线/细胞健康产品, 实现多赛道技术转化。

Stem cell platforms + 1M-dose/year exosome lines + cell health products for multi-track translation.

 

创新生态网络

Innovation Ecosystem

携手顶尖学研机构,构建自主知识产权护城河。

Co-building IP moats with elite universities and research institutes.

 

QbD质控体系

QbD Excellence

研发端锁定CQA(控制/质量/保证), 定义前瞻性质量标杆。

Defining CQAs (Control/Quality/Assurance) at source to set proactive quality standards.