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Raw materials for mRNA therapeutics

GMP Grade reagents for mRNA synthesis in therapeutics development and production

mRNA therapeutics have recently entered the limelight as new front in combating cancer, treating infections, and improving replacement therapies. The novelty of mRNAs as therapeutic agents entails uncertainties and new regulatory expectations as you transition from development through clinical manufacturing.

Choosing the right critical mRNA raw materials and the right supply partner is key to a seamless transition.  Our commitment to next generation manufacturers and in support of the evolving market needs, Roche CustomBiotech’s fit-for-purpose mRNA raw materials reduce unnecessary uncertainties for your clinical development through commercial manufacturing. 

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 across the globe.

 

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Development to manufacturing: considerations for optimizing mRNA production

Selecting the right critical raw materials during the development helps you to smoothly transition into a routine manufacturing process. Learn more about his pivotal decision in this webinar hosted by GEN.

Gain peace of mind and certainty with our fit-for-purpose mRNA raw materials

 

As a manufacturer of mRNA therapeutics, we want you to focus on the development of your drug and rely on us and our fit-for-purpose mRNA raw materials to facilitate every step on your path to commercialization.  We understand that your mRNA platform may have unique requirements and continue to optimize our entire portfolio, ensuring products are fit-for-purpose and provide the level of safety required.

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Ongoing portfolio optimization so you can focus on drug design and clinical studies, and increase certainty in your manufacturing process

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Quality and safety to match your process and, avoid redesigns, saving you time and costs

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Scalable as demand increases from development to manufacturing 

mRNA synthesis workflow with CustomBiotech

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1. DNA Plasmid Construction

The first step in in vitro mRNA synthesis is to prepare the DNA template containing the sequence of interest. The DNA template must contain a double-stranded promoter region, specific to the RNA polymerase, in order for the polymerase to bind and initiate RNA synthesis.

The template for in vitro transcription (IVT) can be a plasmid construct, a cDNA generated from an RNA template, an oligonucleotide or a PCR product. When a plasmid construct is utilized, the desired DNA sequence is inserted into the plasmid construct by cloning.

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2. DNA Plasmid Manufacturing

When using a plasmid construct as a DNA template for IVT, it is crucial to amplify the construct to ensure that there is enough template to produce the desired amount of RNA downstream. To do so, the construct is transformed into bacterial host cells and proliferated in culture media.

More recently PCR is leveraged as a technology to amplify the DNA template. Upon completion of amplification, plasmid construct is harvested and purified.

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3. DNA Plasmid Linearization

The plasmid DNA template is linearized using restriction enzymes. Linearization of template plasmid increases accessibility of the target sequence by polymerases. In addition, it ensures that the transcripts of a defined length and sequence are generated.

Restriction enzyme digestion should be followed by purification of the linearized template to eliminate impurities that may inhibit transcription.

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4. in vitro Transcription

RNA is synthesized in vitro by utilizing the linearized plasmid as a template. A T7, SP6 or T3 RNA polymerase initiates transcription by binding to their promoter sequence that is adjacent to the transcript sequence. The RNA polymerase utilizes ribonucleoside triphosphates (NTPs) to synthesize the RNA.

If the sequence for polyA tail is part of the DNA template, the tail will be added at the 3´ end of the mRNA by the RNA Polymerase. A cap structure can be added during the transcription process or post-transcriptionally.

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5. mRNA Purification

For generating clinical grade mRNA for therapeutic applications, it is essential that the mRNA is free of contaminating impurities resulting from up-stream processes. Impurities such as the plasmid DNA backbone are enzymatically digested by DNase I.

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6. Post-Transcriptional Modification

A mature eukaryotic mRNA contains a 5´cap structure and a polyA tail at the 3´ end. These entities can be added during the IVT reaction or post-transcriptionally using capping enzymes and polyA polymerase.

 

They are essential elements to offer protection to the mRNA from nuclease digestion, enhance stability and are important for translational regulation.

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Product portfolio mRNA raw materials

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Product portfolio mRNA raw materials

In ongoing projects CustomBiotech optimizes the entire portfolio to meet fit-for-purpose standards. The specifications are determined by their intended use in manufacturing therapeutic mRNA.

Product GMP Grade Animal-origin-free1 ß-Lactam 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
DNase I, rec., RNase-free Yes -2 Yes Yes planned
Ribonucleotides, 100 mM:
ATP Yes No2,3 Yes Yes -
CTP Yes No2,3 Yes Yes -
GTP Yes No2,3 Yes Yes -
UTP Yes No2,3 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 * = subject to change in ongoing project.

Regulatory disclaimers are listed on the respective product pages.

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