We can provide cGMP aseptic fill of vials from 2 mL to 100 mL. Our capabilities include lyophilization, terminal sterilization, and inert gas purge and overlay. Our team can validate the manufacturing process and provide you with a variety of CMC supporting services to ensure your project’s success. For a complete list of services, download our data sheet.
Within the controlled classified spaces are manufacturing suites to support preparation, compounding, and fill finish with each area having dedicated air handling units to prevent cross contamination. WFI and clean steam are generated on-site and have distribution systems that are routinely monitored. Other facility features include a Depyrogenation oven, autoclave, passive RABS filling line and a filling machine with weight check capability. The entire manufacturing facility is supplied with 100% emergency power from an on-site generator.
Our expert team can develop and scale up your formulation. We have expertise working with liquids, lyophilized products, emulsions, suspensions, and liposomes. A development lab and pilot facility are adjacent to the cGMP manufacturing areas, and our analytical chemistry and microbiology labs can quickly and accurately collect analytical data to support development and manufacturing.
Together with Nitto Avecia, we can provide end-to-end oligonucleotide drug development solutions. Nitto Avecia can manufacture your drug substance in their FDA-inspected manufacturing facility, with Nitto Avecia Pharma Services preparing the formulated drug product, for a seamless experience.
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
