Expert Process Development

Based on our best-view platform, Veliter’s Process Development offers industry-leading development services to solutions tailored to individual customer needs, from the lab to validation and commercial manufacture. Our experts team will ensure our approaches are aligned with regulatory guidelines and GMP industry best practices.

Experience makes the difference

Veliter’s development and scale-up experience covers various therapeutic oligonucleotide modifications (special nucleotides, PS/PN replacement of PO, chemical modification on 2’ position of nucleotides, 2’-4’ locked nucleotides, chemical modification on phosphorus, conjugated oligonucleotides,etc) in the market. Our technical team constantly explores and brings you emerging chemical modifications and processes.

Process or transfer

A customized oligo process can come from your development team after technical transfer or directly from Veliter’s process development. Through our VPS™ program, Veliter can offer a starting point for development to reduce development time and minimize manufacturing risk at the same time.

Customized approach

Your project is unique in entire development. Veliter provides solutions tailored for your project including: facility risk assessments, small scale modeling of large scale manufacturing, product specification development/justification, raw material vendor selection and qualification, and a dedicated manufacturing project manager.

Commercial offer

Veliter is capable of supporting you with commercial oligonucleotides and beyond.

Process development capabilities:

Synthesis, cleavage and de-protection, purification, and downstream processing of various complex and modified DNA, RNA and analogue oligonucleotides
Pre-clinical non-GMP and GMP-like oligo production
Process parameter screening and robustness testing using Design of Experiments
PS, PO, PN and mixed backbone sequences
Conjugation including GalNAc，PEG and analogues etc.
Sequences from <10 to <150 bases
Process Performance Qualification activities and support

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.