Quality Control and Stability Study
for Your CMC Needs

QC and stability study for your CMC needs

Understanding the vital role that quality control testing and stability study play in all facets of your project, Veliter’s QC group has the expertise and resources for you to keep your project on track.

In-process and release testing

Working independently or partially with our qualified contract lab, Veliter’s QC department performs all cGMP necessaried testing of raw materials, intermediates, APIs and drug products including duplexes and conjugates after manufacturing, and generates a comprehensive certificate of analysis. Our own cGMP lab and qualified contract lab are close to our manufacturing suites, enabling fast turnaround times.

Stability study services

Experts from Veliter and our qualified contract lab can help you design a comprehensive stability study to meet regulatory guidelines for your drug substance or drug product. We have qualified on-site ICH sample storage to meet a range of temperature and humidity requirements. Our team will pull samples, perform testing, analyze the data, and provide a comprehensive stability study report.

Reference standard supplying and testing

Veliter’s experienced chemists can produce high quality various reference standards to meet your project needs. Our QC department, in cooperation with our Analytical Development, can characterize, qualify and store reference materials for your project needs.

Microbial limits testing

Our QC group provides process micro risk assessments and in-process micro studies to support your API. We also perform environmental sampling and monitoring of the onsite purified water system and the ISO-8 manufacturing areas. We have the resources in place so you can manufacture your drug substance with confidence.

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.