Newsletter | March 18, 2024

03.18.24 -- Regulatory & GMP Manufacturing Insights Into mRNA-LNP Drug Products

Developing A Comprehensive Regulatory Approach For LNP Drugs

Lipid nanoparticles (LNPs) have emerged as a promising delivery system for mRNA vaccines and therapeutics. However, this versatility entails complex regulatory considerations, as each therapeutic area has distinct requirements, safety profiles, and efficacy benchmarks. Learn how adopting proactive and strategic approaches to leveraging regulatory pathways can help to navigate complex frameworks.


Insights Into GMP Manufacturing Of RNA-LNP Drug Products

Compliance with GMP standards is imperative throughout the manufacturing of RNA-LNP drug products to mitigate risks, maintain product consistency, and uphold patient safety. Gain insight into how a flexible workflow that leverages advancements in production, automation, and digital technologies can streamline manufacturing to accelerate time-to-market.


Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing

Speed to market is critical, but the path to developing a commercial mRNA-LNP drug product is complex, with challenges at every stage. Find out why single-use technology is gaining attention for its ability to facilitate a reliable and robust manufacturing process for biopharma manufacturers looking to scale up mRNA therapeutics.


Key Stages In mRNA-Based Therapeutic Development

Each regulatory phase of mRNA-based therapeutic development consists of specific goals, steps, and endpoints. There are also some unique challenges and risks. Explore the fundamentals of manufacturing mRNA-LNP vaccines and therapeutics from discovery through to commercialization.


Process Development Considerations For RNA-LNP Therapeutics

Process development is a challenge for any drug developer, and evaluation of both upstream and downstream steps is needed to gain end-to-end process insight across the entire manufacturing workflow. Learn how a robust manufacturing process ensures the safety and efficacy of mRNA-LNPs.