|
Quality Control
Avecia's OligoMedicines on-site QC Laboratories have the capability to carry out of the majority of the release testing required for bulk oligonucleotide APIs. The few tests which we require to be outsourced are carried out by our audited sub-contractors. Our QC laboratories operate under our Quality System following the ICHQ7A guidelines. At Avecia our core expertise is in oligonucleotide manufacture and analysis, it's all we do!
Overview of QC activities
- raw material testing - amidites, supports, reagents, solvents
- in-process testing - synthesis, cleavage/deprotection, purification
- final API testing
- environmental monitoring
- support for R&D, Process Development, troubleshooting
- stability testing
Typical API release tests include:
Identity
Molecular weight
Sequencing
PS/PO content |
Quality
Sodium content
Moisture content
Endotoxin
Bioburden |
Purity
HPLC (IEX, RP)
CGE
Residual solvents limit
Trace metals limit |
Strength
Assay |
|
|