IN VITRO CELL BASED POTENCY ASSAY

The present disclosure provides an in vitro cell based potency assay to determine the relative potency of a composition, including a pharmaceutical composition, comprising an mRNA encapsulated in a lipid nanoparticle (LNP) as compared to a reference sample. Also provided is a process for releasing o...

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Bibliographische Detailangaben
Hauptverfasser:	PATEL, Nisarg, M, DEPHILLIPS, Peter, A, XU, Jingyuan, ZHANG, Zhi-Qiang
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	BEER BIOCHEMISTRY CHEMISTRY COMPOSITIONS OR TEST PAPERS THEREFOR COMPOSITIONS THEREOF CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL ORENZYMOLOGICAL PROCESSES CULTURE MEDIA ENZYMOLOGY MANUFACTURE OR TREATMENT OF NANOSTRUCTURES MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEICACIDS OR MICROORGANISMS METALLURGY MICROBIOLOGY MICROORGANISMS OR ENZYMES MUTATION OR GENETIC ENGINEERING NANOTECHNOLOGY PERFORMING OPERATIONS PROCESSES OF PREPARING SUCH COMPOSITIONS PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES SPIRITS TRANSPORTING VINEGAR WINE
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Beschreibung
Zusammenfassung:	The present disclosure provides an in vitro cell based potency assay to determine the relative potency of a composition, including a pharmaceutical composition, comprising an mRNA encapsulated in a lipid nanoparticle (LNP) as compared to a reference sample. Also provided is a process for releasing or accepting a batch of a pharmaceutical composition comprising an mRNA encapsulated in an LNP using the in vitro cell based potency assay. The methods and processes described comprise (i) transfecting a population of cells with a test sample of the composition, (ii) transfecting a different population of cells with a reference sample of the pharmaceutical composition, wherein the cells in step (ii) are the same cell type as the cells in step (i); (iii) detecting the amount of expression of a polypeptide encoded by the mRNA in the transfected cells; and comparing the amount of expression, thereby determining the relative in vitro potency of the composition.