Solving Imminent Regulatory Challenges With Single Use Technologies For mRNA Vaccine Production

By Ben Wylie

The market for mRNA (messenger Ribonucleic Acid) vaccine technology is expanding rapidly. mRNA vaccines stimulate the immune response in a patient’s body. Instead of the vaccine containing a weakened/inactivated form of the virus, the vaccine contains genetic material coding for a disease-specific protein to the virus. Though manufacturing, mRNA technology comes with a list of challenges, the biggest obstacle being achieving compliance with GMP Annex 1 regulations. Here, we dive into the compliance issue and explain how companies who want to use mRNA vaccine technology can address challenges through the use of single-use technologies (SUTs).