

As mRNA programs progress, the demand for both quantity and quality escalates. At INOMIXO, we specialize in producing high-quality mRNA tailored to your specifications, utilizing scalable processes capable of delivering from milligram to multi-gram quantities. Moreover, we offer linearized plasmid DNA to support your in vitro transcribed mRNA synthesis requirements. With our commitment to excellence, we ensure that your mRNA needs are met efficiently and reliably, empowering the advancement of mRNA-based therapies.

Drug Substance Manufacturing Process

Drug Substance Manufacturing IVT Synthesis

Drug Substance Manufacturing Ivt Synthesis

We can offer enzymatic capping (two-step method) and co-transcriptional capping (one-step method) to add caps at the 5' end of RNA, enhancing RNA stability and translational efficiency. We also analyze and refine the composition of nucleotides, reagents, and enzymes, as well as optimize process conditions in the development phase.

Drug Substance Manufacturing QC Testing

At INOMIXO, we provide comprehensive testing for critical attributes such as purity, identity, concentration, total residual protein content, residual DNA template, residual endotoxin content and bioburden etc.

Quality	Attribute	Method
Identity	Sequence Confirmation	Sanger Sequencing
Content	RNA Concentration	UV
Potency	Activity Assay	In vitro Transcription Assay
Purity/ Integrity	5’ capping efficiency	LC-MS/RP-HPLC
	3’ poly(A) (% or length)	LC-MS/RP-HPLC
	A260/A280	UV
Impurity	Product Related impurities – dsRNA	ELISA/dot-blot
	Process Related impurities - Residual Protein	Fluorescent Dye Method
	Process Related impurities - Residual Template	qPCR
	NTPs	HPLC
Safety	Endotoxin	CHP<1143>
Safety	Bioburden	CHP<1101>