Q: What methods should I use in mRNA therapeutic manufacturing to synthesize RNA at a large scale efficiently?

 Cell-based methods for producing RNA often involve complex and labor-intensive processes that require extensive cell culture steps, making them time-consuming. These methods can also introduce several types of contaminants, including host cell proteins, which can interfere with the purity and functionality of the final RNA product. Additionally, DNA from the host cells can be unintentionally incorporated into the RNA preparations, leading to further contamination.

Another significant issue is the presence of endotoxins, which are toxic components derived from bacterial cell walls that can compromise the safety and efficacy of the RNA therapeutics. The need for stringent purification processes to remove these contaminants adds to the overall time and complexity of cell-based RNA production. Consequently, cell-based production of RNA is a complex process that can fail to consistently produce highly pure RNA that meets the requirements for use in RNA therapeutics and underscores the need for more efficient production techniques.

Get training in Lab Crisis Preparation and earn CEUs.

One of over 25 IACET-accredited courses in the Academy.

Lab Crisis Preparation course

A: The use of in vitro transcription (IVT) addresses several key challenges in mRNA therapeutic manufacturing, including scalability, consistency, speed, and flexibility.

IVT is a cell-free method used to synthesize RNA molecules outside of living cells. This process involves using a DNA template, RNA polymerase, nucleotides, and other necessary reagents to produce RNA in a controlled environment. IVT allows for rapid production of large quantities of high-purity RNA with precise control over the synthesis process, ensuring batch-to-batch consistency. Additionally, IVT systems can be easily customized to produce various RNA molecules by simply changing the DNA template, making it a versatile and efficient solution to produce an RNA therapeutic.

Promega supplies Animal Origin-Free (AOF) and cGMP-manufactured in vitro transcription reagents that are suitable for use as raw materials in RNA therapeutic research, development and production. These AOF IVT reagents consistently produce a high yield of RNA transcripts of varying size. Promega IVT raw materials can be easily customized to meet your specific workflow needs, making them suitable for small-scale research and development through large-scale manufacture of RNA in an RNA therapeutic manufacturing workflow.

Learn more about their advanced mRNA manufacturing solutions to enhance your RNA production capabilities: www.promega.com/CustomIVT