in vitro transcription (IVT) production and bottling service for mRNA drug-like substance material

The National Institute of Standards and Technology (NIST) is seeking a sole source provider for in vitro transcription (IVT) production and bottling service for mRNA drug-like substance material. The goal is to produce a reference standard that can be used by the biomanufacturing industry to underpin critical quality attribute (CQAs) measurement assays for mRNA drug substance. The reference standard will enable quality control of mRNA assays over time and between assays, establishing necessary traceability for assuring safety and supporting regulatory submissions. The provider must have the necessary intellectual property rights and licensing authority to produce and provide mRNA generated by IVT using modified uridines. Some key aspects of the job include: • Production of mRNA reference material • Use of modified uridines in the production process • Compliance with applicable intellectual property restrictions • Ability to ensure lawful resale and redistribution of the reference material through NIST as a Standard Reference Material (SRM) • Technical capability to synthesize mRNA • Possession of required licensing rights for the specific application