Thank you to our speakers, sponsors, and delegates who joined us for the summit! If you are interested in the 2024 event, please get in touch at info@hansonwade.com

Supporting Optimized Purity, Stability & Raw Material Testing for Vaccine Developers to Set Quality Standards at Scale & Avoid GMP Obstacles to Accelerate the Development & Release of Safe & Effective mRNA Medicines


June 13-15, 2023 | Boston, MA

Welcome to the mRNA Quality Control & Comparability Summit: Streamlining Regulatory Approval for Superior mRNA Therapeutics & 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 & 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.

Our audience joined the main industry players as they navigated through their case studies and shared their experience!

Expert Speakers Included:

Emily English

Vice President - Quality

Cartesian Therapeutics

Jan Michel Falcke

Director Global Analytical Science & Technology

BioNTech

Rachel Groppo

Director

JNJ

Vishal Mukund Sonje

Commercial Manufacturing Lead

CEPI

This was the must-attend event for mRNA Quality Control, Quality Assurance, CMC, Regulatory & Analytical Development Scientists – our attendees joined us in Boston alongside pioneering speakers from innovative biopharma and KOLs of academia.

If you were unable to join us, you missed out on networking with those shaping the advancement of standardized regulatory requirements & documentation processes to ensure robust commercial processes are in place for the development of mRNA-based therapeutics and vaccines.

2023 Highlights:

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Improve Stability Testing & Implementation for Optimized Stability

Understand ways to set up and implement stability in early phases to match regulatory requirements and allow a rapid approval

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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

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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

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Understand Ways to Develop & 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

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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

Other Events in the World RNA Series: