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 and immunotherapies to protein replacement 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 high quality raw materials: mRNA reagents portfolio at a glance

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

Restriction endonuclease Xba I

from Xanthomonas campestris pv. Badrii, expressed in E. coli, solution

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
SP 6 RNA Polymerase, rec., AOF Planned 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-Pseudo-UTP, GMP Grade, AOF Yes Yes Yes Yes Yes
Pseudo-UTP, AOF - 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
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 No TSE/BSE certificate available
Yes Yes No
DNase I, rec., RNase-free Yes TSE/BSE certificate available Yes Yes Planned
* Production process is GMP except for the activity test using hemoglobin as substrate.

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 ISO13485:2016 certified QMS and more

Discover the revolutionary potential of mRNA as a platform for biopharma

mrna

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

Read about mRNA technology and related manufacturing processes

Regulatory disclaimers are listed on the respective product pages.

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