Many oligonucleotide products are formulated for parenteral administration and then lyophilized. We optimize your formulation by evaluating your drug’s solubility and stability and checking for compatibility with excipients. We have all the necessary capabilities to develop, optimize, and validate a lyophilization cycle for your product. Our studies are conducted under protocol to generate data that will support your regulatory filings.
We can provide cGMP aseptic fill of vials from 2 to 10 mL. We offer lyophilization, terminal sterilization, and inert gas purge and overlay. 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. Learn more about our parenteral manufacturing services.
Oligonucleotide analysis requires specialized expertise not available at all manufacturers. We have experience developing and validating analytical methods for all types of oligonucleotide products and can perform release testing and stability study testing. We can also perform LC-ESI-MS/MS and HRAMS analyses through Nitto Avecia.
With over 25 years of experience in oligonucleotide production and more than 1,200 sequences manufactured, Nitto Avecia has played an integral role in advancing the oligonucleotide therapeutic market. We can quickly produce small quantities of oligonucleotides for formulation development work or large cGMP quantities to support late-phase and commercial formulation. Learn more about our drug substance 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
