White Paper

Establishing Analytical Methods For mRNA-Based Therapies

mRNA GettyImages-1428646288

Nucleic acid-based modalities, such as pDNA and mRNA vaccines, offer diverse options for addressing unmet medical needs. The efficacy of the SARS-CoV-2 vaccines has demonstrated the versatility of mRNA as well as its potential for rapid market availability. Given the complexity of this emerging modality, rigorous characterization and testing are required to ensure safe and effective mRNA drug products.

mRNA modalities can be manufactured using a pDNA template or in vitro transcription and must be formulated into the final drug product for targeted delivery, often by encapsulating the mRNA into a lipid nanoparticle (LNP). A comprehensive set of analytical tests are required to ensure the quality and safety of these nucleic acid assets.

Both the RNA drug substance and the formulated drug product should be subjected to stringent testing prior to release. Here, we provide a detailed description of assays for sequence identification and LNP compositional, two critical quality attributes of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Biosimilar Development? Subscribe today.

Subscribe to Biosimilar Development X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Biosimilar Development