Challenges in fluid management of mRNA
Fluid management of drug substances presents several challenges in mRNA production. Handling and maintaining the quality of biologics throughout the manufacturing process can be complex. Proper control of more technical fluid parameters, such as temperature, pressure, and flow rates, is crucial to ensure the integrity and stability of RNA drug substances.
Dispensing the exact amount of liquid is an important aspect in filling mRNA. Small-volume single-use bags are often mixed with just an additional solution and given directly to the patient - the amount of active ingredient in the single-use bag is therefore crucial for the health of the patient.
Another significant risk during fluid management is contamination, potentially compromising the quality and safety of mRNA drug substances. Maintaining aseptic conditions, implementing proper cleaning and sterilization procedures, and utilizing high-quality materials are essential to mitigate contamination risks.
Furthermore, filling processes must adhere to stringent GMP or cGMP guidelines including Annex 1 defined by the Food and Drug Administration (FDA) to ensure the highest level of safety, quality, and efficacy of mRNA drug substances. Compliance with cGMP requires robust documentation, validation of equipment and processes, and thorough quality control measures.
Finally, scalability is an issue for commercial production - as demand for mRNA products increases, the scale-up of fluid management processes becomes crucial. Scaling up vaccine production from clinical trials to commercialization while maintaining consistent product quality and meeting regulatory standards can be challenging.
At Single Use Support, we have been working intensively for years on safe and efficient handling of bulk drug substances. Our modular automated aseptic filling platforms are leading fluid management technologies in all processes during vaccine manufacturing. Note, that our area of responsibility lies before the final fill-finish into vials.