GMP mRNA Sequencing Services for Drug Substance and Encapsulated Drug Product

Seeking a qualified outsource laboratory or GMP-compliant sequencing service provider capable of performing analytical sequencing for purified mRNA drug substance and encapsulated final drug product samples. The project involves three distinct 2539 nucleotide mRNA constructs containing unique 12 nucleotide barcode sequences within the ORF region to enable differentiation through sequencing and/or PCR analysis.

Each drug substance sample will be formulated in citrate buffer at pH 6.4 with an mRNA concentration of 1 mg/mL. The final drug product will consist of equal encapsulation of all three constructs, with the final formulation media to be determined. Desired capabilities may include sequence verification, barcode differentiation analysis, identity confirmation, integrity assessment, and GMP-compliant analytical reporting for both bulk and encapsulated mRNA materials.