VAV Lifesciences, through its subsidiary VAV Lipids, has agreed with a US-based multinational contract development and manufacturing organisation (CDMO), to manufacture and supply highly purified synthetic phospholipids suitable for vaccine manufacturing. The CDMO will use lipids made by VAV to produce gene-based lipid nanoparticles (LNPs) on behalf of brand owners namely Pfizer-BioNTech and Moderna.
VAV Lifesciences is the only Indian company whose lipids will be used in the mRNA-LNP technology-based vaccines, informed a statement. The company has already initiated a commercial supply of phospholipids for large-scale vaccine manufacturing through its EU cGMP certified facility under its subsidiary company, VAV Lipids, based at Ratnagiri in Maharashtra.
Phospholipids are crucial biomolecules used in the manufacturing of m-RNA based COVID-19 vaccines. These synthetic lipids are used in the formulation of lipid nanoparticles (LNPs), very tiny lipid particles which enclose submicroscopic mRNA strands. These LNPs effectively deliver the mRNA to the target cellular sites and help bind these to the relevant cells. Since mRNA, on its own, is extremely sensitive to degradation and rapid breakdowns, lipid nanoparticles (LNPs) ensure the protection of the mRNA until its uptake in cells. This results in a better cellular response and efficacy against virus replication, significantly enhancing the overall immunogenic response of vaccines.
Speaking about this development, Arun Kedia, MD, VAV Lifesciences said, “While a lot of importance has been given to the bottling and distribution of vaccines, there is little understanding of the science behind the formulation of lipid nanoparticles (LNP). LNP technology is considered a medical breakthrough in vaccine-based delivery systems. It has enabled the development of mRNA-based Covid-19 vaccines at a blistering pace. We are proud to be the first and only Indian company to produce high-quality phospholipids that have been approved for use in these novel vaccine delivery systems.”
According to the company, contrary to what most people think, the volume of lipids utilised in vaccine delivery is very small and measured in micrograms. Hence the mRNA-LNP concentrate is produced in small amounts. Each order volume is about 250 kg and is roughly valued at Rs 50 lakh (approximately $67000). However, the platform of gene delivery is transformative to human health and offers profound possibilities of disease elimination and cure.
VAV has already started receiving orders on a regular basis from the CDMO. Of this, about 80 per cent of the order quantity has been either delivered or is in the supply chain with new orders already under discussion. VAV will manufacture all its synthetic phospholipids at its EU cGMP certified facility at Ratnagiri in Maharashtra.