Starting Materials
Arranta Bio has partnered to offer select starting material process development and manufacturing services from dedicated laboratories and cGMP suites. This offers access to platform processes and analytical capabilities and technical expertise that allow you to move quickly from research to clinical trials.
Capabilities include:
- Strain selection
- Colony isolation and RCB generation
- Platform production, purification, and linearization processes
- Process transfer and optimization
- Research and clinical-grade production
mRNA
Arranta Bio has dedicated process development laboratories with appropriate scale-down equipment for mRNA process establishment and development, including:
- Plasmid linearization
- Transcription reaction/mRNA synthesis
- Enzymatic capping and tailing
- DNA digestion
- RNA purification including capture or other chromatography—product or process impurity removal studies, binding capacity, loading/elution buffer studies, elution/fraction collections studies, etc.
- buffer exchange and/or concentration including filter configuration, flow rate, TMP, diafiltration volume, and loading studies
- Process transfer and optimization
- Non-cGMP mRNA production
- Freeze-thaw and forced degradation stability studies
mRNA Lipid Nanoparticles
Our process development laboratories include dedicated space for establishing, developing and/or optimizing mRNA encapsulation and lipid nanoparticle formation and final formulation steps, including:
- Solvent-based lipid emulsification
- Lipid nanoparticle mRNA encapsulation— mixing technology platforms including microfluidics, T-junction mixing, and jet mixing
- Chromatographic or filtration based polishing or final formulation steps including process and product impurity removal, dilution, concentration and buffer exchange step optimization
- Non-cGMP LNP production
- Freeze-thaw and forced degradation stability studies
Filling
We can accommodate non-cGMP, small-scale filling in our process development laboratories for drug product process establishment work or for non-clinical material production needs:
- Sterile filtration studies
- Container closure system evaluation
- Non-cGMP production
- Non-cGMP stability and forced degradation studies
