欧洲标准局IRMM JRC 参考物质证书 EURM-014_SYNTHETIC SINGLE STRANDED RNA product_information_sheet_v1.pdf

JOINT RESEARCH CENTRE Directorate F – Health, Consumers and Reference Materials REFERENCE MATERIAL PRODUCT INFORMATION SHEET ® EURM - 014 SYNTHETIC SINGLE STRANDED RNA DESCRIPTION OF THE MATERIAL EURM-014 consists of a stabilised in vitro transcribed (IVT) synthetic single stranded RNA (ssRNA) of 1670 nt (sequence reported in Annex 1). The molecule was designed at the European Commission’s Joint Research Centre and consists of five non-overlapping sequences of the SARS-CoV-2 genome (described in detail in Annex 2). Positions of these sequences in the reference sequence SARS-CoV-2 are illustrated in Figure 1. In addition to the SARS-CoV-2 specific sequences, the synthetic RNA also includes part of the human RNase P gene (Annex 2 and Figure 2). The DNA fragment was cloned by synthesis in a pUC57 plasmid by GenScript (Rijswijk, Netherlands). Sequence verification of the fragment was carried out using Sanger DNA sequence. AmpTec GmbH (Merck group, Hamburg, Germany) manufactured the IVT RNA using the linearized plasmid as a template. Production was in compliance with ISO 13485, including regulations of FDA CFR Part 820 (cGMP manufacturing) without open deviations and without open out-of-specification. Imagene (Pessac, France) was in charge of the vacuum-dry and encapsulation processes. The solution produced at AmpTec was