Product Portfolio

Raw materials for mRNA therapeutics and vaccines

GMP Grade and fit-for-purpose reagents

Already decades in development, the SARS-CoV-2 pandemic first thrust mRNA therapeutics into the limelight. From vaccines, immunotherapies and protein replacement to gene editing and cell reprogramming, interest in mRNA manufacturing has surged. Today, therapeutic developers have the room and attention to bring innovations to market. Competition is growing. Regulations are crystalizing.


Remaining at the front of this fast-paced therapeutic space hinges not only on ideas and implementation, but also on development speed and product safety. As a manufacturer, the first are your expertise. As a long-standing global supplier of raw materials, we help make the latter happen. We help you strengthen your supply chain, ease transfers to manufacturing, secure continuous production, and create consistently high-quality products.

This is the “why” of CustomBiotech: GMP Grade and fit-for-purpose raw materials to seize opportunities that improve healthcare.

 

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The shortest path to mRNA therapeutic success starts with quality starting materials: mRNA reagents portfolio at a glance

The shortest path to mRNA therapeutic success starts with quality starting materials: mRNA reagents portfolio at a glance

Product

GMP Grade

Animal-origin-free
AOF1
Antibiotic-free Tested for RNase /
DNAse activity

Extended impurity testing4

T7 RNA Polymerase, rec., GMP Grade Yes Yes Yes Yes Yes
Pyrophosphatase, rec., GMP Grade Yes Yes Yes Yes Yes
RNase Inhibitor, rec. GMP Grade Yes Yes Yes Yes Yes
Ribonucleotides, 100 mM:
ATP Yes -2,3 Yes Yes -
CTP Yes -2,3 Yes Yes -
GTP Yes -2,3 Yes Yes -
UTP Yes -2,3 Yes Yes -
N1-Methyl- PseudoUTP Planned for mid 2022 Yes Yes Yes Yes
1 For details see certificates of origin. 2 TSE/BSE certificate available. 3 Orthogonal virus depletion steps included in manufacturing process (e.g. virus retentive filter). Further information on virus depletion study is available. 4 Includes e.g. testing for bioburden, endotoxin, heavy metals, host-cell DNA, host-cell protein, if applicable

Product

GMP Grade

Animal-origin-free
AOF
Antibiotics-free Tested for RNase /
DNAse activity
Extended impurity testing for e.g.
bioburden, endotoxin, heavy metals, host-cell DNA, host-cell protein
Proteinase K, rec., PCR Grade Yes Yes Yes Yes Yes
DNase I, rec., RNase-free Yes - TSE/BSE certificate available Yes Yes Planned

Find out what GMP Grade and fit-for-purpose means for our mRNA reagents

mrna

A core commitment to quality, safety and efficacy with advanced quality mRNA reagents.

Read about our ISO13485-certified QMS and more here

Discover the revolutionary potential of mRNA as a platform for biopharma

mrna

Find out more about the attractive mRNA technology opportunities in therapeutics, gene therapy or vaccine applications.

Read about mRNA technology and related manufacturing processes

Regulatory disclaimers are listed on the respective product pages.

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