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.

Partner with us to access:

  • Technical partnership — Leverage tools and technical expertise to enable process development, scale-up, and commercial manufacturing
  • Quality at scale — Seamlessly progress from preclinical development to commercial manufacturing and regulatory filing with the TheraPure GMP product portfolio
  • Proven products — Access standard portfolio of products used in multiple clinical and commercial mRNA vaccines and therapeutics
     
*“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.
mRNA production, purification, lipid nanoparticle encapsulation, fill and release, and therapeutic applications.

Figure 1: Overview of mRNA production and applications. Quality and purity are critical to process performance and patient outcomes from Phase I to commercialization.


mRNA production materials

mRNA production process showing key steps and in vitro transcription (IVT) reaction components

Figure 2: Overview of materials used in mRNA synthesis process for mRNA production.


TheraPure GMP product portfolio for scalable and seamless 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:

Quality icon Quality

Scalability icon Scalability

Proven products icon Proven products

Flexibility icon Flexibility

Consistency icon Consistency

Documentation support icon Documentation support

The TheraPure GMP product portfolio enables seamless scale-up of mRNA productionfrom 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:

  •    Manufacturing following relevant ICH Q7 GMP principles
  •    Animal origin–free (AOF) manufacturing process and raw materials
  •    Validated manufacturing processes and analytical methods
  • ✓   Product specific stability data
  •    Impurity profile
  • ✓   Verified compendial test methods, where applicable
  •    Manufactured in and β-lactam–free facilities
  •    Quality support documents available including CoA, COO, TSE/BSE statement, nitrosamine statement, melamine statement, etc.
     

Table 1. TheraPure GMP product portfolio for mRNA production

Standard concentration and packaging are available to support development through to commercial scale.

 

Product description

Concentration

DNA template linearizationEam1104I20 U/μL
In vitro transcriptionATP, sodium solution100 mM
CTP, sodium solution100 mM
GTP, sodium solution100 mM
UTP, sodium solution100 mM
N-1-Me pseudo UTP, sodium solution100 mM
Pyrophosphatase, inorganic0.1 U/μL
Pyrophosphatase, inorganic1 U/μL
T7 RNA polymerase200 U/μL
RNase inhibitor40 U/μL
DNA template removalDNase I, RNase-free50 U/μL

mRNA synthesis by in vitro transcription, using TheraPure GMP products

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.


TheraPure customization capabilities

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.
 


Manufacturing sites for raw materials for mRNA production

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.

Vilnius (EU)

Vilnius (EU)

Milwaukee, WI (USA)

Milwaukee, WI (USA)

Carlsbad, CA (USA)

Carlsbad, CA (USA)

Austin, TX (USA)

Austin, TX (USA)

A video tour of the Therapure GMP product manufacturing site in Vilnius, Lithuania

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.