Messenger RNA
Biomay offers end-to-end services for GMP manufacturing and testing of messenger RNA and template DNA. At the company’s mRNA Competence Center, we operate our in-house developed platform for in-vitro transcription, mRNA processing and lipid-nanoparticle formulation.
cGMP-grade mRNA
Biomay is among the few CDMOs capable to supply all of these three key molecules: mRNA, recombinant protein and plasmid DNA. Our clients in the mRNA field are active in infectious diseases (e.g. COVID-19 vaccines) and cancer immunotherapies.
Biomay offers GMP manufacturing services for clinical-grade messenger RNA (mRNA). Our clients request manufacturing of mRNA as such (by enzymatic in-vitro transcription, IVT) as well as the respective linear DNA templates.
Our mRNA production platform:
Technical features of Biomay's proprietary mRNA platform:
- Full scalability from 100 mg to 50 g per batch
- Optimized in-vitro transcription (IVT)
- Platform proven for any length (1 to >10 kb), including self-amplifying RNA (saRNA)
- 5‘-Capping optionally co-transcriptional or post-transcriptional
- 3‘-poly(A) tail: flexible in length (50-150 bp)
- Modified nucleosides implemented on client´s demand
- High yield / high quality by optimized affinity chromatography (oligo dT)
- Process based on single-use components
- Process free of animal components, antibiotics, organic solvents
- Comprehensive set of QC assays in-house
- One-stop and fully cGMP from DNA template, over mRNA to final lipid-nanoparticles
Services offered for mRNA:
- GMP manufacturing of mRNA drug substance bulk
mRNA aseptic filling (drug product) - Process development for mRNA
- Analytical development / QC method qualification for mRNA
- QC testing, QP release and regulatory support
- ICH stability testing & long-term storage
Services offered for linear DNA (IVT starting template):
- GMP manufacturing of linear DNA template
- Design and construction of start plasmid
- GMP cell banking for linear DNA template (plus testing, release, storage)
- QC testing, QP release and regulatory support
- ICH stability testing & long-term storage
Analytical assays for mRNA (GMP Quality Control):
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General Parameter
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mRNA-specific Parameter
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mRNA-specific QC assay
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|---|---|---|
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Identity
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Sequence
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Reverse transcription & Sanger sequencing
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Identity
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Homogeneity
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Agarose gel electrophoresis
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Identity
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Capillary electrophoresis
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|
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Content
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mRNA concentration
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UV260
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Purity / integrity
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Homogeneity
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Reversed phase HPLC
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Purity / integrity
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5’-capping efficiency
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LC/MS
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Purity / integrity
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3’-poly(A) length
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LC/MS
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Impurity / product related
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Double stranded RNA
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ELISA
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Impurity / process related
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Residual DNA template
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qPCR
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Impurity / process related
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Residual protein
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NanoOrange™/ BCA
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Safety
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Endotoxin
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Chromogenic LAL
(Ph. Eur. 2.6.14 D)
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Safety
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Bioburden
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Bacteria, yeasts, molds
(Ph. Eur. 2.6.12/ USP<61>)
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Safety
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Sterility
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Sterility (Ph.Eur. 2.6.1 / USP<71>)
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Lipid-based nanoparticle formulation
Biomay offers GMP services for formulation of mRNA as lipid-based nanoparticles (LNPs):
- GMP manufacturing of LNP-formulated mRNA
- Process and analytical development (e.g. integration of custom-specific lipids)
- Development of analytical assays for LNPs
- Aseptic filling of LNPs for clinical or research use
Biomay has in place a powerful set of LNP-specific analytical assays to perform GMP-conform quality control, including:
- Dynamic light scattering / DLS to determine LNP size and polydispersity
- Fluorometric determination of encapsulation efficiency and mRNA content
- LC/MS to determine identity and content of the lipids
- Capillary electrophoresis for mRNA integrity
- Rapid sterility testing
Besides mRNA, the LNP platform can also be applied for other (non-coding) RNA formats, such as micro RNA, small-interfering RNA or guide RNA.
Related Services
From sequence to product
Biomay is your one-stop-shop for GMP manufacturing services.
