One lab, three paths to faster outcomes
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
pDNA Template Creation
Design plasmid DNA templates for mRNA transcription. Ligate from oligonucleotide fragments or outsource design and synthesis to service providers.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
pDNA Template Testing
Analyze plasmid templates for purity and sequence fidelity before transcription. Analytical methods developed here should be validated and designed with scalability to production environments in mind.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
in vitro Transcription
Synthesize mRNA oligos in one-pot transcription reactions containing all enzymes and raw materials, including optional 5’- or 3’-modifications. Quality control of all reagents and raw materials is essential for consistent product.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Conditioning
Exchange synthesized mRNA into a post-reaction buffer, removing remaining molecules and contaminants from transcription reactions. Analyze mRNA transcripts, ensuring synthesis reactions are occurring as expected.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
mRNA Capture
Remove mRNA oligos from solution and wash to ensure transcripts are a single species for downstream process steps. Develop validated analytical methods to assess mRNA oligos as purification protocols scale.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Polishing
Perform additional preparation chromatography and any additional enzymatic processing of oligonucleotides before encapsulation into lipid nanoparticles.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Formulation and Bulk Fill
Formulate mRNA oligonucleotides into a stable buffer appropriate for freezing and storage. Transfer mRNA to analytical laboratories or downstream development labs.
Perform freezing and packaging trials to simulate how molecules respond to handling stress. Protocols established here will aid in successful cGMP manufacturing.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Analytical Testing
Develop SOPs that analyze purified mRNA and lipid nanoparticles. Developing analytical methods that transfer from R&D to cGMP is critical for understanding final drug product at enterprise scale.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Tech Transfer to GMP
Scale preparation and analytical methods established in development to production volumes or outsource to enterprise operations using cGMP-grade raw materials and reagents.
