Development and manufacturing

Our oligonucleotide API process development and manufacturing platform offers comprehensive services, from preclinical to commercial stages. We’ve established industry-leading capabilities and capacities to support your needs across all development stages, ensuring knowledge retention throughout the product lifecycle.

Best-View platform

Powerful database to support process search, fast locking process
Unique synthesis process, greatly saves the cost of raw materials
Efficient purification and freeze-drying process, greatly improve the final product yield and impurity control
Support for rapid process transfer, process validation and process optimization

We support various oligonucleotide modalities, including but not limited to:

DNA | ASO | PMO
miRNA | siRNA | sgRNA
Aptamer
Various Sugar / Backbone Modified Oligonucleotides

Process Development

Covers a broad range of molecule types, including ASO, siRNA, aptamer, PMO
Utilizes a variety of modified monomers in our processes (2′-H, 2′-OH, 2′-F, 2′-OMe, 2′-OMOE, LNA, cEt, LNA)
Specializes in the synthesis and analysis of chiral oligonucleotides
Capable of modifying the 3′-end and/or 5′-end of molecules for a variety of compounds, including GalNAc, triphosphate, cholesterol, peptides, and maleimide, among others

Our Manufacturing Assets

Synthesis

4 AKTA OligoPilot plus 100
1 AKTA OligoPilot 150 (under construction)
2 AKTA OligoPilot 400
1 OligoPilot (under construction)
1 Oligo Process (under construction)

Chromatography

4 AKTA Pure 25
3 AKTA Pure 150
2 AKTA Pilot 600 (1 under construction)
1 AKTAProcess
1 Bioprocess (under construction)

Ultra-filtration

3 Small scale UF skids
4 Large scale UF skids (under construction)
Flexible scale UF apparatus

Freeze-drying

3 Small scale systems
1 Mid scale systems
2 Large scale systems (under construction)

Manufacturing We provide one-stop service from API to drug product. We have several GMP production lines of different sizes to meet different specifications, covering the whole life cycle from pre-clinical research, clinical trials to commercialization. Our formulation team has extensive experience in injectable drug development.

Dose Forms

Solution/ Emulsion
Suspension
Lyophilized powder
LNP

Filling Formats

Vials
Prefilled syringes
Cartridges

Ultra-filtration

Heat-moist sterilization
Sterile filtration

Case study siRNA Drug Candidate lND Filing Ready in 10 Months

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.