The objective of the service, it said, is to support the discovery and early preclinical development of RNA-based therapeutics and vaccines. It will leverage eTheRNA’s proprietary lipid libraries and formulations to facilitate targeted delivery and tailored biodistribution solutions, with the idea of allowing customers to maximize the delivery of their RNA-products.
The CDMO said its LNP formulation platforms employ a range of mRNA and lipid mixing technologies and will provide the market with differentiated alternatives to the LNP formulations in use currently.
David Ricketts, director of business development at eTheRNA Manufacturing, told BioPharma-Reporter:
“We have seen that many of our customers for drug substance RNA production are also looking for drug product delivery systems. As this fits well into our three base pillars of RNA development, namely - RNA chemistry, formulation and process technologies, we decided to extend our contract development and manufacturing activities into the formulation field.
“In this way, we can offer the full scale of RNA product development from construct design, formulation design and the processes needed to manufacture the products, and help these customers bring their products to the clinic and beyond by providing an integrated service.”
The company said the recent COVID pandemic has facilitated the rapid development and approval of the first-wave of COVID-19 RNA vaccines, which has led some people to underestimate some of the complexities of developing a RNA-based therapeutic or vaccine.
“Development of efficacious and safe RNA-based medicines requires a unique set of skills and resources to simultaneously advance both the active drug substance and the correct formulation required for the drug product. Through our long-established focus on RNA manufacture and delivery, and associated proprietary technologies, we have engineered libraries of custom lipids, which enables our LNP formulation team to design the most appropriate LNP for mRNA applications.”
Engineering LNP properties
Existing lipids and formulations are non-optimal for targeting of certain key tissues and organs, continued Ricketts. “In developing our platform, we have taken a new approach to engineering key LNP properties that enable much improved control over tissue targeting.”
The LNP service can cover product needs for early research and development and can be further optimized and upscaled to the requirements for toxicological studies and later to GMP productions for clinical trials, commented Ricketts.
The target customers are small to mid-size companies, focused on R&D, preclinical and clinical supply in both oncology as infectious disease and other potential indications.
