PINE Site
The top priority of gene and cell therapy products during transportation is to maintain the integrity of the products, as well as ensuring them arrive their destination on time and within temperature specification.
As one of the Innovation Demonstration Units certified by the customs of Shanghai Technology Innovation Center, we have successfully supported our clients with their international cold-chain transportation of samples for clinical trials in the United States and Australia. We partner with multiple international cold-chain transportation vendors to help you with the whole journey of cold-chain transportation and temperature monitoring from GMP facility to the customs, ensuring compliance with requirements in terms of delivery schedule, expiration date and temperature. We also assist you to provide documentation required for declaration at China Customs, accelerate declaration process, ensuring our gene and cell therapy products delivered to the destination you designated as soon as possible.
PINE Site currently functions as our cGMP manufacturing platform. It is a three-building, 10,000 ㎡ (107,639 ft²) campus situated at Banxia Road. in Shanghai International Medical Zone. The name PINE is inspired by the technical name (Pinellia Ternate) for Banxia, a herb in Traditional Chinese Medicine. At PINE Site, we have established a large-scale, flexible cGMP manufacturing process and a comprehensive quality system for gene and cell therapy products, which enables us to provide customers with contract development and manufacturing services in conformity with FDA and NMPA standards.
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