Ethris and Lonza agreed to collaborate on the development of room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates, designed for mucosal delivery to combat respiratory diseases.
Room-temperature stability aims to address significant supply chain challenges associated with some mRNA vaccines, including the dependence on ultra-low-temperature storage and complex delivery systems, according to Carsten Rudolph, PhD, CEO, Ethris. Overcoming these challenges will simplify production, reduce costs, and support rapid, scalable vaccine development, he added, noting that spray-dried formulations of mRNA-based vaccine candidates aim to enable needle-free nasal administration, potentially achieving mucosal immunity.
“Together, I believe we are well positioned to create promising noninvasive mucosal vaccine candidates that could potentially transform how respiratory diseases are prevented globally,” Rudolph said.
The initial focus of the collaboration is to develop a first-in-class mRNA vaccine candidate against influenza delivered nasally. This noninvasive approach is designed to provide localized immune responses with an immune effect comparable to intramuscular vaccines and could reduce virus transmission by generating mucosal immunity at the site of virus entry.
Lonza will provide spray-drying and particle engineering for vaccine candidates based on Ethris’ stabilized non-immunogenic mRNA (SNIM® RNA) and stabilized lipid nanoparticles (SNaP LNP) platform at its Bend, OR, site, which specializes in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles.
“Spray-drying represents a well-established technique that addresses solubility and other manufacturing and stability challenges,” pointed out Jan Vertommen, head of commercial development, advanced synthesis. “However, its application in the field of DNA and RNA-based products represents a highly innovative approach, with another level of complexity introduced by the presence of LNPs.”