mRNA Quality Control and Comparability Summit
June 13 - 15, 2023 - MA USHanson Wade
info@hansonwade.com
Phone:+1 617 455 4188
Welcome to the mRNA Quality Control and Comparability Summit: Streamlining Regulatory Approval for Superior mRNA Therapeutics and Vaccines There is very little known about the types of parameters that should be included in the quality control and evaluation of mRNA therapeutics and vaccines, and the methods currently used are difficult to standardize and compare. In order to aid the global need for quality assurance of mRNA vaccines, we need a common and mutual understanding with confirmed regulations on the analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccines. The mRNA Quality Control and Comparability Summit is a platform for industry experts to discuss and share strategies for ensuring the quality and consistency of mRNA-based products throughout their lifecycle, from raw material testing to stability, potency, and purity testing, as well as life cycle management. Join the main industry players as they navigate through their case studies and share their experience! This is a must-attend event for mRNA Quality Control, Quality Assurance, CMC, Regulatory and Analytical Development Scientists - join us in Boston alongside pioneering speakers from innovative biopharma and KOLs of academia. Avoid missing out on networking with those shaping the advancement of standardised regulatory requirements and documentation processes to ensure robust commercial processes are in place for the development of mRNA-based therapeutics and vaccines. Meet your community face-to-face in 2023 to hear how they address the major challenges facing the industry: Improve Stability Testing and Implementation for Optimized Stability Understand ways to set up and implement stability in early phases to match regulatory requirements and allow a rapid approval Deconvolute Critical Regulatory Insights for Guidance on an Efficient Approval Discuss the most updated opportunities and learnings that the regulatory agencies are requesting, as well as leading biopharma companies' strategies to streamline through an approval Review Considerations for Purifying mRNA Therapeutics Explore the advancements in overcoming purification challenges for mRNA product development to create a successful and purified mRNA medicine Understand Ways to Develop and Manufacture Consistent Quality LNPs for Efficient mRNA Drug Delivery Uncover why the production of LNPs with specific sizes and PDI according to the regulatory requirement remains a challenge in mRNA delivery and what the advances are to overcome this bottleneck Delve into the Analytical Comparability Consideration of mRNA therapeutics from the Early Phase to the Late Phase Reveal ways to manage the qualification of analytical methods during the lifecycle of your mRNA product and understand the comparability considerations that play a role in rapid approval rate Join us June 12-15, 2023 in Boston, MA!