Webinars » CGT » mRNA One-stop Solution: Plasmid, Linearized DNA, IVT-mRNA, mRNA-LNP and QC sharing

mRNA One-stop Solution: Plasmid, Linearized DNA, IVT-mRNA, mRNA-LNP and QC sharing

Topic 1：Integrated mRNA One-stop Solution

    Dr. Xiao Pan
  • Speaker: Dr. Xiao Pan, Sr. Director, Platform R&D Dept.
  • Date: Sept. 5th, 2023
  • Time:14:00-16:00 (GMT+8)

Speaker Biography

Dr. Xiao Pan, Director of Platform R&D Department, manages the platform process R&D department to develop process R&D platforms based on antibodies, proteins, and gene cell therapy. Dr. Xiao Pan received his Ph.D. from the Department of Bioengineering, Wageningen University, the Netherlands. In 2017, he worked as an important scientist at FujiFilm Diosynth Biotechnology Company in the United Kingdom, as the technical director of the upstream cell line development department and process development department, including process design, development, amplification and characterization. Dr. Pan joined GenScript in 2018, responsible for the upstream process development process, and led the CMC work of more than 20 IND projects.

Topic Background

The production of mRNA therapeutics and vaccines is a complex process that begins with pDNA manufacturing and ends with fill and finish by using different delivery technologies. Currently, there are some mRNA candidates in late-stage trials or commercial stage. The CDMOs that involved those drug development cycles usually support one aspect of the process, such as pDNA production, mRNA production or LNP formulation, etc. With strong plasmid process development, manufacturing capabilities and global project experience, ProBio establishes the high-quality services in the field of mRNA, providing customers with one-stop solutions from plasmids to mRNA, including plasmids and linearized DNA manufacturing, in vitro transcription of mRNA (IVT-mRNA), lipid nanoparticle (LNP) formulation and sterile filling.

Topic Abstract

  • Introduction of ProBio and service landscape
  • Progress in mRNA technologies
  • IVT mRNA CMC development considerations
  • mRNA delivery system CMC considerations

Topic 2：The Challenges and Solutions in Quality Analytics for mRNA Products

    Dr. Lauren Lu
  • Speaker: Dr. Lauren Lu, Sr. Director of QC Dept.
  • Date: Sept. 5th, 2023
  • Time:14:00-16:00 (GMT+8)

Speaker Biography

Dr. Lauren Lu, Sr. Director of QC Dept, has almost 15 years of experience in analytical method development for biomacromolecules including recombinant protein and antibody, plasmids, mRNA and virus. She received her Ph.D. in Analytical Chemistry from EPFL, Switzerland and then joined in GenScript as a senior scientist in 2012. During 2018 to 2020, she was in charge of Analytical Development Dept. and well organized the analytical activities including method development, testing strategy, CQA definition and method qualification over 20 CMC projects. She is now charge of Quality Control (QC) Dept. in ProBio since 2020 and is experienced in the laboratory operation to conform with GMP regulations including starting materials, drug substance and drug product in gene and cell therapy.

Topic Background

Messenger RNA (mRNA) products are emerging as a promising modality for vaccine and therapeutics after the COVID-19 pandemic. Nevertheless, insufficient scientific studies and industry knowledge of the molecule propertis of mRNA and the lipid nanoparticles (LNP) as well as manufacturing process lead to huge analytical challenges during CMC development. The key features for mRNA’s quality analytics are obvious: there are many complicated intermediates during the whole manufacturing process (plasmid, mRNA, LNP) and rapid changes of knowledge of process and products and as well as the regulations. Therefore, a State-of-the-art analytical platform including structure analysis, physico-chemical analysis, in vitro and in vivo functional assay is crucial to mRNA products’ quality analytics and the orthogonal approach to analyze the same critical quality attribute (CQA) can provide more intrinsic information. To well address these challenges, several case studies are shared according to Probio’s experiences. For example, it’s known that the poly A tail contributes to both the translational status and stability of mRNAs. How to well characterize poly A tail starting from plasmid template to mRNA and what is the correlation between plasmid and mRNA are shared here. Also, how to interpret the inconsistency of the integrity of mRNA by using orthogonal approach is also included in case studies.

Topic Abstract

  • Understand the trending of diverse therapeutics are of mRNA products
  • Explore the challenges in quality analytics of mRNA products based on QbD principles
  • Learn the whole picture of quality analytics of mRNA and LNP
  • Case studies show ProBio how to deal with these Challenges