Expert Analytical Development

Veliter’s analytical development is the premier choice for analytical services covering all stages of drug development. Our 10’s years of analytical experience with oligonucleotides, together with our practical instrumentation, ensure reliable results to facilitate your program’s success.

Comprehensive solution from development to CMC/regulatory fillings

Veliter quality unit stays closely and stage by stage with you at every step of the drug development process—from method development, transfer, and validation to ICH stability studies to support CMC documentation for regulatory filings. The specialized challenges of oligonucleotide analysis, including raw materials, intermediates, adjuvants, APIs/DSs and DPs.

Phase-appropriate analytical development

Oligonucleotide sequencing

Liquid chromatography and electrospray ionization mass spectrometry (LC-ESI-MS/MS) will be utilized to sequence oligonucleotides. While oligonucleotides up to 50 bases are typically confirmed with 85%-100% coverage using the standard approach, oligonucleotides over 50 bases are subjected to specific enzyme digestions followed by LC-ESI-MS/MS. Veliter has experience on sequencing highly modified oligonucleotides within 150 nts.

Oligonucleotide quality control

To ensure the integrity of our facility and your oligo products, our Quality Control team performs test under the ICH requirements as follow:

environmental monitoring;
raw material, in-process and final product analysis;
stability testing;

Most API and intermediate release testing is performed onsite, and offsite testing facilities (contract labs) are audited and approved periodically under our quality management system.

Our typical release testing include:

Appearance

pH

Molecular Weight

Sodium content (%w/w on anhydrous basis)

Molecular sequence

Residual solvents (head-space Capillary GC)

Identity by HPLC (IEX, SEC)

Halides

Thermal Melt (Tm)

Heavy metals (or full metal scan)

Purity and Impurity Profile (HPLC, UPLC, LCMS)

Bacterial endotoxins

Assay

Bioburden

Water content (%w/w)

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.