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- GMP Oligonucleotide APIs: Manufacturing & Quality Control
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Oligonucleotide API CDMO
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GMP Oligonucleotide APIs: Manufacturing & Quality Control
- Service Description
- GMP-compliant Oligonucleotide API Manufacturing / Process Development
- Quality Control / Analytical Method Development
Service Description
We provide oligonucleotide drug substances (APIs) for clinical and commercial use under GMP.
Beyond manufacturing planning, we flexibly design process development, scale-up, and analytical methods according to project objectives and development stages.
GMP-compliant Oligonucleotide API Manufacturing / Process Development
Manufacturing is conducted under a management system compliant with GMP and PIC/S.
Manufacturing methods, scales and analytical conditions are flexibly designed according to project objectives and development stages.
GMP Facility Layout (7 Areas)
Quality Control / Analytical Method Development
We provide contract analytical services covering a wide range of quality tests required for nucleic acid therapeutics.
Analytical method development and synthesis of impurity reference materials (e.g., N-1/N+1 and depurinated species) are also available.
List of Quality Tests
| No | Test Item | Equipment |
|---|---|---|
|
1
|
Appearance | — |
|
2
|
Purity (Assay) | HPLC |
|
3
|
pH | pH meter |
|
4
|
Identification Test (Molecular Weight) | Q-TOF LC/MS |
|
5
|
Identification Test (Sequence) | Q-TOF LC/MS |
|
6
|
Purity and Impurity Profile | Q-TOF LC/MS, HPLC |
|
7
|
Tm Value (Duplex) | UV-Vis Spectrophotometer with Tm Analysis System |
|
8
|
Water Content | Karl Fischer Moisture Titrator |
|
9
|
Sodium Content | ICP-MS |
|
10
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Elemental Impurities | ICP-MS |
|
11
|
Residual Solvents | GC-MS |
|
12
|
Endotoxin | Toxinometer |
|
13
|
Total Microbial Count | Membrane Filtration System |