How to improve plasmid and viral vector manufacturing process

Speaker: Shigang Wei, Director of Plasmid & Virus Process Development Department
Date: Nov. 26 th , 2020

CGT is a type of personalized medicine that can treat a number of diseases which traditional treatment methods are not effective or cannot be applied. Plasmid DNA and lentiviral vector (LVV) are widely used as delivery vehicles in CGT products, but process development and manufacturing of plasmid and LVV are facing many challenges, such as high cost, lack of clinical grade supply, scaling up, low yield, etc.

Plasmid DNA can be used as a raw material to produce virial vectors, such as LVV and AAV. High production yield in the range of milligram to gram per liter level is a must for biopharmaceutical industry. For the manufacturing of LVV, the capability to produce clinical grade LVV in large scale is the most significant limiting factor for industry development.

GenScript ProBio lays out plasmid platform and viral vector platform, and has accumulated experience in manufacturing plasmids as different use, such as raw material, drug substance or even drug product. For viral vector platform, GenScript ProBio has a mature adherent system to produce lentiviral vector. Besides, viral vector manufacturing with suspension culture is also available, which not only solves the industrial bottleneck in large scale manufacturing, but also reduces the material cost significantly. From Pre-clinical through clinical to commercial supply, GenScript ProBio is marching forward to support more cell and gene therapies to success.