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    Raw materials for mRNA therapeutics

    Reduce uncertainties

mRNA therapeutics - from development to manufacturing

Though discovered over 50 years ago, mRNA has only recently entered the limelight as a potential therapeutic agent. in vitro transcribed mRNAs are engineered to elicit protein expression either in immune cells as a new front to treat cancer and combat infections, or in other tissues to improve replacement therapies. 

The novelty of mRNAs as therapeutic agents entails uncertainties for their introduction to market and a seamless transition from development to manufacturing is key to success.

Selecting the right critical raw materials during the development of these new drug modalities with the foresight to smoothly transition into a routine manufacturing process may be a pivotal decision.

Scale and quality for industrial use

Whether for development or large-scale mRNA production, our raw materials meet strict manufacturing and quality criteria, perform in narrow specifications and are delivered at the right scale and across the globe. Focus on the development of your drug and rely on us and our raw materials to facilitate every step on your path to market.

  • Manufactured under time-tested, state-of-the-art GMP quality standards
  • Highly consistent from lot-to-lot
  • Available in scale and quality for every stage – from development to manufacturing
  • Backed by the expertise and know-how of a global pioneer in diagnostics and pharmaceuticals

Focus on the development of your drug and rely on us and our raw materials to facilitate every step on your path to market.

    

Product portfolio:
Reagents for mRNA therapeutics from Roche CustomBiotech
 

Product Animal-free* ß-Lactam antibiotic-free  Tested for RNase / DNAse activity Extended impurity testing****
T7 RNA Polymerase,
rec. GMP Grade
Pyrophosphatase, rec., GMP Grade
RNase Inhibitor, rec., GMP Grade - in development
DNase I, rec., GMP Grade  -** planned
Ribonucleotides, 100 mM:        
ATP, GMP Grade -**/***
CTP, GMP Grade -**/***
GTP, GMP Grade -**/***
UTP, GMP Grade -**/***

* For details see Certificates of Origin, ** TSE/BSE certificate available,*** Orthogonal virus depletion steps included in manufacturing process  (e.g. virus retentive filter). Further information on virus depletion study is available. **** Includes e.g. testing for bioburden, endotoxin, heavy metals, host-cell DNA, host-cell protein


mRNA Therapeutic
Manufacturing Workflow


Matching CustomBiotech products

mRNA 1


 

T4 DNA Ligase
Alkaline Phosphatase
PCR reaction buffer components, e.g. MgCl2
dNTPs
Ready-to-use PCR reaction buffers and purification kits on request contact us
mRNA 2
Option in vivo:
Residual DNA E.coli Kit 
MycoTOOL Mycoplasma Real-Time PCR Kit
Plasmid Midi or Maxi Kits contact us
Option in-vitro (PCR):
PCR reaction buffer components: MgCl2
dNTPs
Ready-to-use PCR reaction buffers and purification kits on request contact us
mRNA 3


 

Restriction Enzymes such as XbaI or SAPI.
More on request contact us

Ready-to-use restriction-buffers contact us

mRNA 4
T7 RNA Polymerase / soon: SP6 RNA Polymerase
Pyrophosphatase / Alkaline Phosphatase
RNase Inhibitor
Native ribonucleotides
(ATP, CTP, GTP, UTP)
Modified ribonucleotides (N1-Methylpseudo UTP, Pseudo-UTP contact us)
Capping enzymes and ready-to-use IVT reaction buffers contact us
IVT reaction buffer or single components: MgCl2
mRNA 5


 

DNase I, rec., in glycerol  
Proteases such as Proteinase K
Degradation reaction buffer or single components:
MgCl2Pefabloc SC, more on request
Ready-to-use degradation reaction buffers and purification kits on request
 
mRNA 6


 


 


 


 

Need a partner and supplier to optimize your in vitro mRNA synthesis workflow?
You have found what you were looking for. 
Get in touch with your local CustomBiotech team.

Regulatory disclaimers are listed on respective product pages.