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 and mRNA processing.

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:

Plasmid template > Linearization > In-vitro transcription > mRNA purification > Formulation & filling

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 to final mRNA
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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):

General Parameter
mRNA-specific Parameter
mRNA-specific QC assay
Identity
Sequence
Reverse transcription & Sanger sequencing
Identity
Homogeneity
Agarose gel electrophoresis
Identity
Capillary electrophoresis
Content
mRNA concentration
UV260
Purity / integrity
Homogeneity
Reversed phase HPLC
Purity / integrity
5’-capping efficiency
LC/MS
Purity / integrity
3’-poly(A) length
LC/MS
Impurity / product related
Double stranded RNA
ELISA
Impurity / process related
Residual DNA template
qPCR
Impurity / process related
Residual protein
NanoOrange™/ BCA
Safety
Endotoxin
Chromogenic LAL (Ph. Eur. 2.6.14 D)
Safety
Bioburden
Bacteria, yeasts, molds (Ph. Eur. 2.6.12/ USP<61>)
Safety
Sterility
Sterility (Ph.Eur. 2.6.1 / USP<71>)

Related Services

From sequence to product​

Biomay is your one-stop-shop for GMP manufacturing services.