Breaking Technological Bottleneck
PINE Site currently functions as our cGMP manufacturing platform. It is a three-building, 10,000 square meter 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.
Our services at PINE Site include:
● Process Development
● Analytical Method Development
● Technology Transfer and Process Scale-up
● Non-clinical Investigation Service
● IND-Enabling CMC Service (IND-CMC)
● Phase I & II Clinical Manufacturing
● Bank Construction (Strain, Cell, Virus Seed Stock)
● Aseptic Fill and Finish
● Stability Study
Please contact us for customization needs. Our experts will be responsive to your requirements at first instance.
Building No.8, Lane 100, Banxia Rd,
Pudong New District,