Democratizing GMP Manufacturing for the New Therapeutic Pipeline

At the 11th International mRNA Health Conference in Berlin, Germany, held Oct. 29– Nov. 2, 2023, conversations on the show floor Illustrated the exuberance that a Nobel Prize confers on messenger RNA (mRNA) technology, while highlighting the molecular diversity challenges and opportunities new therapies create when entering the manufacturing process.

Many mRNA therapies and other types of genetic medicines in clinical development are designed to be delivered with the help of lipid nanoparticles. One such platform is Cytiva’s Precision Nanosystems NanoAssemblr microfluidic-based nanoparticle manufacturing platform, which enables the development of genetic medicines with potentially increased stability, efficacy, yield, and quality of non-viral genetic medicines, according to Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, in a discussion with Pharmaceutical Technology Europe® at the conference. Ripley was enthusiastic about this platform’s ability to “democratize” the good manufacturing practice (GMP) manufacturing aspects for advanced therapies, while managing to cope with the increased molecular diversity of the molecules being handled.

“For example,” Ripley says, “the mRNA platform is unique in that, on one end of the spectrum, it is vaccinating the planet, on the other end, it’s personalized cancer vaccines.”

All these must fit into the new GMP manufacturing ecosystem. The fact that the poster sessions in Berlin were plentiful and quite well attended gave attendees a window into what new approaches and angles are being tried and offered a glimpse as to what is in store for the future of medicines.