Drug Substance Manufacturing top 10

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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INOMIXO is an innovative company dedicated to providing multi-omics solutions in the field of life sciences. https://www.inomixo.com/