Analysis platform
Veliter has a dedicated analytical team with extensive experience and expertise in oligonucleotide analysis across all development phases from pre-clinical development to commercial manufacturing, covering both drug substance and drug product.
API process development team
We equipped with state-of-the-art instruments and co-located with the API process development team, our oligonucleotide analytical service streamlines your oligonucleotide development process with a customized, flexible, and integrated analytical solution.
Quality Control
- Method qualification and validation (IND/NDA)
- Transfer GMP validated methods according to USP <1224>
- Full release testing (raw materials, reagents, intermediates, drug substance and drug product)
- Accelerated and long-term stability studies under ICH compliance
Analytical Development
- Drug Substance Specific Analytical Services
- Analytical development for drug substance specific methods (purity, sequencing) and feasibility for oligonucleotide generic methods
- Forced degradation study with impurity qualification and quantitation
- Release testing and stability study under R&D conditions
- Reference standard and impurity marker qualification and retesting
- Physicochemical property study and structure elucidation
- Microbiological safety: endotoxin limit and quantitation testing, bioburden for microbial limit test, microbe ID and strain typing
- Container-Closure Integrity Testing (CCIT), including quantitative testing such as vacuum decay method, high-voltage leak detection and qualitative testing such as microbial challenges, tracer liquid, etc.
- Foreign and particulate matter observe in situ, verifying by flow imaging (MFI) and identifying via IR/Raman/EDX, osmolality
- Purity by LC-MS, including ID and quantitation utilizing Q-TOF HRMS and quadrupole LC-MS specifically for hard-to-resolve parenteral impurity analysis
- Sterility and microorganism identification
Oligonucleotide drug testing program Assets
Experience Highlight
- Study of complex impurities (PS isomers, monomer isomers, difficult n-1 or PS impurities)
- Experience in improving the quality of 10+ PPQ/Pre-PPQ research
- Quality research experience of 5+ marketed oligonucleotide products
Positive oligo program experience, from end to end
Focusing on your needs and building long-term partnerships, your own Veliter’s project manager will be flexible and responsive. This is Veliter’s approach to make your oligonucleotide program move smoothly through pre-clinical to commercial.
Our Awards
