Drug Product Formulation & Manufacturing

Specializing in oligonucleotide therapeutics

Veliter is an expert partner handling the entire process—from API (drug substance) development through fill finish manufacturing of drug product—with consistent quality. Veliter’s formulation department offers you a comprehensive and a seamless end-to-end oligonucleotide manufacturing solution to deliver your fill and finish needs for your project’s success.

Oligo-specific analytical services

Veliter can develop analytical methods tailored to a specific type of oligonucleotide or assist in technical transfer of methods from other service providers for your drug substance and drug product analytical method development and validation. We perform various testing to support product release, including compendial testing.

Stability study services

With help you design a comprehensive stability study to meet regulatory guidelines, our team will manage your samples, perform testing, analyze the data, and finally provide a comprehensive report to support successful fill and finish needs of your drug product.

DP manufacturing and CMC/regulatory filling

Veliter offers drug product formulation development, process development and cGMP aseptic fill manufacturing of vials, dedicated to oligonucleotide therapeutics. We can accommodate a variety of vial sizes from 1 to 10 mL and manufacturing scales. We can validate the manufacturing process and provide CMC supporting services for your regulatory filing. We understand many oligonucleotide drugs are produced in small batches, and our equipment can accommodate this without excessive product losses.

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.