Accelerate mRNA vaccine and therapeutics production from pre-clinical development to commercialization with a comprehensive TheraPure GMP* product portfolio and TheraPure customization capabilities that meet critical process, scale, quality, and regulatory needs.
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Figure 1: Overview of mRNA production and applications. Quality and purity are critical to process performance and patient outcomes from Phase I to commercialization.
Figure 2: Overview of materials used in mRNA synthesis process for mRNA production.
mRNA production for process development and cGMP commercial manufacture of an mRNA therapeutic or vaccine require careful choices in many key raw materials. Critical raw material considerations include:
The TheraPure GMP product portfolio enables seamless scale-up of mRNA production—from pre-clinical and toxicology studies to process development and optimization through to clinical and commercial manufacturing.
TheraPure GMP product portfolio is supported by comprehensive quality system and documentation, including:
Standard concentration and packaging are available to support you from development to commercialization.
|DNA template linearization||Eam1104I||20 U/μL|
|In vitro transcription||ATP, sodium or Tris solution||100 mM, 200 mM|
|CTP, sodium or Tris solution||100 mM, 200 mM|
|GTP, sodium or Tris solution||100 mM, 200 mM|
|UTP, sodium or Tris solution||100 mM, 200 mM|
|N-1-Me pseudo UTP, sodium solution||100 mM|
|Pyrophosphatase, inorganic||0.1 U/μL, 1 U/uL|
|T7 RNA polymerase||200 U/μL|
|RNase inhibitor||40 U/μL|
|DNA template removal||DNase I, RNase-free||50 U/μL|
TheraPure GMP products are used in mRNA production on a global scale for vaccine and therapeutic development. The process includes DNA linearization, in vitro transcription, mRNA capping and tailing, purification, and analysis.
In addition to our standard TheraPure GMP product portfolio for mRNA production, custom materials and formulations are available through TheraPure customization capabilities. Contact us to request consultation with a technical specialist.
Our portfolios are supported by industry-leading production capacity and capabilities, enabling a secure and reliable supply of materials. Contact us today to discuss how we can support your projects.
TheraPure GMP portfolio of nucleotides and enzymes are manufactured with rigorous quality standards for mRNA therapeutics and vaccine manufacturing. Take a quick video tour of the site where TheraPure GMP products are produced.
“TheraPure GMP” refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.
For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.