Drug Substance（API）Manufacturing

Premier partner from preclinical to commercial supply

Veliter is one of few real Oligonucleotide CDMO across the world currently. We have the flexibility to provide your first preclinical non-GMP oligonucleotide, from mgs to 10’s of grams, and more than hundred of kilograms of GMP oligonucleotide in support of your commercial supply.

Scale range

Veliter has upstream and downstream processing assets to support oligo production, batches from a few mmols up to 10’s of mmols so far

and we have ample space for further site expansion. This installed and latent capacity provides enormous value to customers who are anticipating a substantial ramp up in commercial demand in the early post launch years. Scale batch 1.5 mol asset is under construction. We have class C and above manufacturing suites and multiple cGMP manufacturing trains. Our assets are distributed into our Dongguan and Changsha locations, allowing us to satisfy you with the best manufacturing choices to make your project success.

Different phase product supply

Veliter has the expertise and resources to support different phase of oligonecleotide supply and the associated regulatory inspections.

Dependable supply chain

Periodic vendor audits, multiple sources of key materials, and capable handling of customer supplied reagents are essential components of Veliter’s reliable supply chain network. These elements work combined with our internal safety qualified storage and testing controls together to ensure the quality and quantity of raw materials for oligo manufacturing.

Drug product cGMP manufacturing

Contract with our formulation partner and formulation asset under construction in our Changsha location, Veliter has the capability to provide formulation development and produce injection type of oligo drug product vials at different scale manufacturing.

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)

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.