ProBio and Kun Tuo, an IQVIA company, have formed a strategic collaboration to provide development, manufacturing and clinical-operations support for biologics and cell and gene therapies in China.
The companies said the collaboration will support investigator-initiated trials, or IITs, and clinical development programs for global biopharmaceutical companies.
The combined services will cover chemistry, manufacturing and controls, nonclinical studies and clinical operations. ProBio will contribute development and manufacturing services for biologics and cell and gene therapies, while Kun Tuo will provide clinical-trial operations and site-engagement support.
The companies said the collaboration is designed to connect manufacturing and preclinical activities with clinical development and trial execution in China.
ProBio said it has contributed to more than 1,000 GMP batches of cell and gene therapy products and supported more than 90 investigational new drug approvals and IIT programs across cell and gene therapy pipelines.
Kun Tuo is a wholly owned IQVIA subsidiary in China. The company has approximately 1,000 employees and has supported more than 1,400 drug and medical-device clinical trials, according to the announcement.
Kun Tuo’s services include identifying clinical trial sites and supporting study execution. The company said it has relationships with clinical sites in China and is supported by IQVIA’s global clinical-development operations.
The collaboration will offer coordinated project management and connect development, manufacturing and clinical activities, the companies said.
ProBio is a contract development and manufacturing organization focused on biologics and cell and gene therapies. Kun Tuo is a clinical research organization operating in China.