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 | - | - |
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.
