Drug products and CMC

What is CMC?

“CMC (chemistry, manufacturing, and control)” refers generally to operations related to chemistry, manufacturing, and analysis on the drug substances and drug products associated with pharmaceuticals.

Development of analytical methods

We develop the analytical methods required for the setting of specifications for nucleic acid medicines as drug substances and drug products.

Setting of specifications and quality assurance

Specifications of nucleic acid as drug substances and drug products are set according to the guidelines of JP, USP, and FDA. Following this, specification tests and stability tests are conducted to confirm whether the products are manufactured correctly according to the specifications and whether the products are stable.

Test item Example of Test Method Equipment
Characteristics Visual inspection -
Liquid state Visual inspection -
pH Japanese Pharmacopoeia pH meter
Identification test Molecular weight LC-MS/Molecular weight calculation software
sequence hydrolysis/LC-MS
Melting temperature Tm analysis system
Quantitative test Content Spectrophotometry/HPLC
Sodium ICP-MS
Purity Ion-exchange chromatography AEX-HPLC
Reverse-phase chromatography RP-HPLC
Related substances (Nucleoside) Enzyme degradation / RP-HPLC
Heavy metal/Arsenic ICP-MS
Residual solvent GC-MS
Water content Karl Fischer titration Karl Fischer Titrator
Endotoxin Japanese Pharmacopoeia Kinetics assay
Microbial limited Test - -

Q-Exactive

Synapt G2

Formulation design

Formulation is developed for highly stable nucleic acid medicines.

What is DDS?

“DDS (drug delivery system) is a technology which enables an appropriate amount of a drug to be delivered only to the area which requires treatment (affected area).

Component technology

Adverse drug reactions are reduced by suppressing the effect in areas other than the target site by means of release control, targeting, and absorption.

Formulation technology

Nucleic acid medicines are manufactured with unique formulation technology which specializes in the delivery of Bonac Nucleic Acid to the target area, including ribosome, micelle, and emulsion.

Route of administration Optimization technology

We determine the method of administration which enables improvement of QOL for the patients as well as highly efficient treatment of the disorder.

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