Overview

OLIGONUCLEOTIDE SERVICES CONCEPT TO COMMERCIAL

CPC Scientific provides research-grade and clinical-grade Oligonucleotide manufacturing services to our clients spanning from discovery to clinical phases.

Clinical phases of Oligonucleotide Manufacturing

OLIGONUCLEOTIDE GMP PRODUCTION & REGULATORY FILING TIMELINE

(based on oligonucleotide length of 20-25mer)

Oligonucleotide Filing Timeline

OLIGONUCLEOTIDE GMP QUALITY AND ASSURANCE

We provide all in-house release testing for typical GMP product specifications.

Test CategorySpecifications
Appearancewhite to off-white solid
Molecular WeightConsistent with calculated molecular weigh
SequenceConsistent with sequence
Purity≥ 90%, according to customer's requirement
Related substancesReport result
Melting temperatureReport result
Water contentNot more than 15%
pHReport result
Residual SolventsReport results for the following solvents: pyridine, acetonitrile, toluene, dichloromethane, ethanol
Elemental Analysis (ICP-MS) Report results for the following metals: Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
BioburdenReport Aerobic and Spore Count, USP guidelines
Endotoxin Report LAL (Gel Clot), USP guidelines
Sodium(Na+) contentReport result
  • Quality Assurance (QA) supervision on-site
  • High standard release for raw material, intermediates & final products by Quality Control (QC)and Quality Assurance (QA)
  • Detailed batch record review
  • Change control managed by Quality Assurance (QA)
  • Corrective and Preventative Actions (CAPA)
  • Environmental monitoring and trend analysis for clean rooms
  • Periodic monitoring of process water systems
  • In-process control test
  • Deviation / Out of Specification (OOS) investigation
  • COA review and approval

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