Development and manufacturing Strategy for DNA Base Vaccine-Drug Candidates
Mark Wei
Sr. Director of Plasmid & Virus Process Development & Manufacturing Department,
Mark (Shigang) Wei, head of CMC for CGT vectors, has 10+ years of experience in biologics CMC, including antibody, recombinant protein and viral vector, from preclinical CMC studies to clinical trials applications. Since 2017, Mark started to lead CGT CDMO platform for the development and manufacturing of plasmid and viral vectors. Varies of new modalities for therapeutic and preventive treatment like pDNA, enzyme, virus like particle, viral vectors and mRNA are under development for global patients now. During his 11 years stay with GenScript, Mark has also leaded, managed and drove dozens of successful IND fillings for CGT in the US, EU, Japan, Korea and China.
Mark Wei obtained his master’s degree at Fudan University in Chemistry. During his 12 years industrial practice, he devoted to development of new technology platform, meeting the fast growing market and customer demand in China and the US, and helping customers improve production quality, efficiency, safety and reliability.
Mark Wei obtained his master’s degree at Fudan University in Chemistry. During his 12 years industrial practice, he devoted to development of new technology platform, meeting the fast growing market and customer demand in China and the US, and helping customers improve production quality, efficiency, safety and reliability.
Time
Topic
Nov.01th, 2022
Mark Wei, Sr. Director of Plasmid & Virus Process Development & Manufacturing Department,
Since the outbreaks of COVID-19, DNA vaccines are promising in the SARS-CoV-2 vaccine race although they have a new platform technology that was not previously available on the market for human use. DNA vaccines can be designed and produced within few days after obtaining the genome sequence of the pathogen or nucleotide sequence of cancer antigens. And India's drug regulator has approved ZyCoV-D, the first DNA vaccine against COVID-19 for emergency use. However, the novel technology platforms and novel development paradigms may increase the risks associated with injecting an approved vaccine, requiring careful evaluation of safety. Thus, how to ensure the quality of plasmid from the source is the key point to meet the strict requirements of DNA vaccines and drugs.