Rely on us for your drug substance and drug product analytical method development and validation. We can develop methods tailored to a specific oligonucleotide or assist in the transfer of methods from other service providers. We perform testing to support product release, including compendial testing. We also offer a full array of product characterization services.
Our experts can help you design a comprehensive stability study to meet regulatory guidelines. Our on-site, cGMP-validated environmental and photostability chambers are monitored 24 hours a day. Our team will manage your samples, perform testing, analyze the data, and provide a comprehensive report. We also perform freeze/thaw studies and have expertise in developing and validating stability indicating methods.
We offer drug product formulation development, process development, and manufacturing dedicated to oligonucleotide therapeutics. We can accommodate a variety of vial sizes and manufacturing scales.
We offer drug substance oligonucleotide manufacturing services through Nitto Avecia. Nitto Avecia has over 25 years of experience in oligonucleotide manufacturing and has produced more than 1,200 sequences. From preclinical to commercial supplies, Nitto Avecia can meet your manufacturing needs. Learn more about our manufacturing services.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
