Quality Control of mRNA/LNP Products

Objectives

Innovations in cell therapy are transforming pharma and biotech by enabling treatments for previously incurable diseases. However, traditional viral transduction methods face challenges such as limited scalability, high costs and potential immunogenicity. Virus-free approaches, particularly RNA-based technologies like mRNA and lipid nanoparticles (LNPs), offer safer and more flexible alternatives. They enable precise, transient genetic modification without risks of genomic integration.

With the rapid advancement of mRNA/LNP platforms, robust quality control becomes essential to ensure safety, efficacy and regulatory compliance. Adherence to standards such as Pharm. Eur., USP and GMP is critical. The pre-conference track on Quality Control for mRNA/LNP Products provides insights into regulatory requirements, microbiological aspects and advanced analytical methods, while facilitating exchange on current challenges and future developments.

Highlights

• Regulatory Developments and Regulators Experiences and Expectations
• Sanger Sequencing vs Nanopore
• Common issues with QC
• Latest developments in RNA analytics
• mRNA vs CAR-T

Moderators

Dr Sabine Hauck, Chair of the ECA ATMP Board
Yasmin Heynen, Labor LS

Target Audience

The Pre-Conference is directed to responsible personnel involved in Quality Control testing of mRNA or LNP based products, e.g.:

• QC and QA Managers
• Laboratory Managers
• Microbiologists, and Process Microbiologists
• Analytical & Technical Experts
• Regulatory Authorites
• R&D Professionals

Congress Registration

Early Bird Rebate: Register until 31 August 2026 and save 100 EUR per congress day.

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