Process Development

Up-Stream Process Development

Industry standard production platforms.

Suspension and adherent cell lines using single-use equipment, fix-bed bioreactor, can accommodate different processes.

Cell line management: MCB, WCB production and storage.

Cell thawing and expansion, transfection, vector harvest optimization.

Down-Stream Process Development

Clarification / chromatography, concentration / diafiltration.

GMP Production Facility

Jinwei has made significant investments in designing, constructing and equipping our facility located in the International Medical Park in Shanghai Pudong Zhangjiang High-tech Park. 

With state-of-the-art laboratory and large-scale GMP production capacity, the facility spreads across 1600 square meters of surface area, and is dedicated to provide process and analytical methods development, full GMP production, with USP and DSP, Fill & Finish, Quality Control & Quality Assurance and regulatory support.

Our comprehensive cGMP (Current Good Manufacturing Practices) gene therapy services include manufacturing of lentiviral vectors for both in-vivo and ex-vivo applications. All material is produced in accordance to major regulation authorities (FDA, EMA, CFDA and etc.).

Fill and Finish System

*Process includes: sterilizing filtration, aseptic distribution, visual inspection / secondary packaging.

*Semi-automated single-use fill-and-finish equipment, under isolator.

*Fill and finish capacity up to 5000 vials.

Quality Assurance and Quality Control

*Fully integrated QC.

*Purity and potency testing.

*Identity testing.

*Sequencing, qPCR, ELISA, Bioburden and Sterility, Endotoxin and Chemical testing.