Bridging the Gap: Developing Solutions for Efficient mRNA-LNP Process Tech Transfer

Innovating in mRNA-LNP therapeutics and vaccines across diverse therapeutic areas, such as oncology, infectious diseases, and rare diseases, in a variety of dosage form presentations requires rethinking process strategies to unlock their full potential. The manufacturing of mRNA-LNP products is closely tied to their specific composition and formulation, which in turn influences the stability profile, and in combination affects the overall efficacy of the drug product. To achieve successful process development and technology transfer, it's crucial to recognize that upstream and downstream processes are interdependent. Addressing and mitigating any gaps in understanding or between sites is essential.

Successful tech transfer demands a collaborative approach, where identifying existing gaps can serve as a roadmap for process development. This presentation will outline the key features of the mRNA-LNP formulation process, emphasizing important areas for process development studies. We will also discuss equipment-related considerations and the factors critical to establishing an in-process control sampling strategy that must be well-aligned with analytical method development to ensure the quality, performance, and stability of the final product.