SFC method development for purification of lipid in COVID-19 vaccine

Abstract: SFC/LC Method Development for Purification of the Lipid (ALC-315) in Covid-19 Vaccine
 

Tony Q.Yan, Frank Riley

Analytical Research and Development, Pharmaceutical Science, Pfizer Inc. Eastern Point Road, Groton, CT 06340, USA
 

Abstract
 

Lipid nanoparticles (LNPs) play an important role in mRNA vaccines against COVID-19.  LNPs can effectively protect and transport mRNA to cells, and also consist of ~80% vaccine weight.  In this presentation, we discuss the supercritical fluid chromatography (SFC) method development strategy for purification on the lipid synthesized by Pfizer chemists internally.  The selectivity and peak shape of the lipid under various SFC stationary and mobile phases were compared, and the best separation condition was selected.  The sample loading on both analytical and preparative columns were studied and optimized.  The solvent usages and throughputs of the SFC method were compared to the LC method.  The detection strategy was also discussed since the lipid has poor UV absorbance.  >100 kgs of the lipid was purified from our site by LC method which was allowed to manufacture tens of millions doses of the Covid-19 vaccine under the emergency uses.  This Pfizer lipid team was selected for the Team Innovation National Award from American Chemistry Society (ACS) in 2023.