Addressing analytical control challenges for different plasmid DNA products Speaker: Lauren Lu, Senior Director of QC Dept Date: Nov.30th, 2022 Watch now Dr Lauren Lu has more than 10 years of experience in analytical method development for biomacromolecules including recombinant protein and antibodies, plasmids, peptides and viruses. She received her PhD in Analytical Chemistry from EPFL, Switzerland and then joined in GenScript as a senior scientist in 2012. She was dedicated to strengthening the capability of biologics testing platform including mass spectrometry, liquid chromatography and capillary electrophoresis to support CMC projects from 2012 – 2018 in GenScript. Between 2018 and 2020 she was in charge of Analytical Development Dept. and organised the analytical activities including method development, testing strategy, CQA definition and method qualification over 20 CMC projects. She has been responsible for Quality Control (QC) Dept. in ProBio since 2020 and is quite familiar with GMP QC lab’s management, especially in the testing platform for therapeutic biomacromolecules including mAbs, plasmids, mRNA and viruses. About this on-demand webinar Plasmid DNA products are one of the most common non-viral vectors, frequently used in both in vivo and ex vivo gene therapies. As a result, they can be utilised as drug substance (DS)/drug product (DP), intermediate or starting material. Also, considering that plasmid DNA products are now used at different clinical trial stages, the quality requirements for these plasmid DNA products during manufacturing are varied, resulting in different analytical control strategies. Analytical control strategies consist of three main parts: analytical method, specification and stability. Many of the latest guidelines issued by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) try to give the answers to current best practice in the diverse applications of plasmid DNA products. Taking into account both the regulations from EMA and FDA and ProBio’s successful Investigational New Drug (IND) filing experiences for plasmid DNA products with different applications, the challenges about how to develop an appropriate analytical control strategy will be addressed here. Why watch? Understand the diverse applications of plasmid DNA products in the market Explore the latest guidelines from EMA and FDA discussing both commercial applications and clinical trial materials Learn the whole picture of analytical control for plasmid DNA products and discover the challenges Seek the current best practice from some case studies.