Implementation of Phase Appropriate Qualification Strategies for mRNA-based IND-Enabling Analytical Platforms

A critical balance between method development and qualification/validation efforts is essential to meet prescribed timelines and effectively control analytical costs.

In this webinar, the expert speaker will delve into the comprehensive analytical requirements for characterizing mRNA-based drug substance (DS) and drug products (DP) for early-phase clinical trials. Attendees will learn how to employ a suite of mRNA analytical platform methods to enhance the process development team’s ability to optimize scale-up and manufacturing processes.

The webinar will cover the effective implementation of full current good manufacturing practice (cGMP) versus process development service analytical offerings within the same laboratory space, thus ensuring compliance and efficiency. The expert speaker will explore the necessary analytical assays required to accurately characterize DSs and DP from mRNA processes, demonstrating strength, identity, safety, purity and quality (SISPQ) for investigational new drug (IND) applications.

Furthermore, strategies for phase-appropriate qualification in multi-construct manufacturing facilities will be discussed, providing attendees with actionable insights into simplifying analytical workflows for mRNA programs. This webinar is particularly suited for those interested in streamlining analytical processes associated with diverse mRNA constructs using similar formulation approaches.

Register for this webinar to gain valuable strategies that can be applied to implementing phase-appropriate mRNA analytics in a contract testing environment.

Keywords: Drug Development, Regulatory, Life Sciences, Analytical Testing, mRNA Technology, Cell & Gene Therapies, CDMO/CMO, Quality, CGT

Others Details

Life Sciences,Pharma,Cell and Gene Therapy