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.

Speaker

Jeffrey Heiser, CSO of Microbial and Advanced Therapeutic Platforms

Jeffrey Heiser is the Chief Scientific Officer (CSO) of Microbial and Advanced Therapeutic Platforms at BA Sciences. After graduating from the University of New Hampshire with a degree in microbiology research in 2007, he entered the industry working for Pfizer Biologics at their site in Andover, MA, where he worked on rapid microbiological methods for multivalent vaccines and biologic products.

Following Pfizer, Jeff joined Genzyme Biosurgery in direct support of autologous knee cartilage and skin graft products. In 2012, Jeff joined BA Sciences where he worked his way to becoming the Director of Microbiology, growing the lab in support of release testing and environmental monitoring. In 2020, Jeff joined Arranta Bio, a CDMO, leading their analytical development and process science efforts in live biotherapeutic products (LBP), plasmid DNA (pDNA) and mRNA modalities.

In 2023, Jeff rejoined the BA Sciences team as the Chief Scientific Officer (CSO) to lead the scientific thought leadership initiatives on microbiological and advanced therapeutic platforms. Advanced therapeutics included not only LBP but also plasmid DNA, mRNA and gene therapy modalities. Jeff’s primary focus in the coming months will be to advance our microbiome expertise and to roll out a comprehensive analytical solution for our mRNA platform clients.

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