Drug Substance Production Manufacturing
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.
Biologics Drug Substance Manufacturing Process
Bulk 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.
Active Drug Substance, Formulated Drug Substance, GMP 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> |
|
Bioburden |
CHP<1101> |
Go to the next platform phase:
mRNA Drug Product Production.
If you want to know more about development and manufacture of drug substances, please visit our website.
INOMIXO is an innovative company dedicated to providing multi-omics solutions in the field of life sciences. By integrating AI big data with advanced mass spectrometry multi-omics technology, along with our team of experienced R&D expertise, INOMIXO has developed two primary business segments, academic omics data analysis services and biopharmaceutical CRO services, creating a business landscape that provides solid, professional, and cutting-edge omics solutions for developing life sciences

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