We work with you to develop a well-defined transfer plan with emphasis on communication. Using single points of contact, we begin with a pre-transfer meeting and then establish a cadence of updates. Required resources and timeline are determined next. With agreement on the types of testing and training in place, multiple lots are evaluated and a transfer report generated. Analytical transfer is not a checkbox function at Argonaut; we take the time to make it right.
We will prep your API to your specifications. Argonaut uses single-use technology for formulation and filling to protect your product. Following formulation the bulk drug is rendered sterile by passing it through two sterilizing filters (0.2 µM).
Our Bausch + Ströbel VarioSys fill line with SKAN isolator technology reduces risk of particulate contamination and of human intervention. We safeguard your drug product with SKAN barrier isolation, single-use disposable fluid path, and pre-sterilized glass vials. ADVANCEDfill technology virtually eliminates product loss during start-up and end of production.
- Dosing ranges from 0.25ml to 30+ml.
- Run rates to 3,600 vials per hour
- Ready-to-use pre-sterilized vials: 2R, 6R, 10R, 20R, 30R
- Stäubli robotic lid and liner removal and denester
- Peristaltic pumping
- Call us for syringe and cartridge applications
Argonaut offers labeling and packaging services following filling activity of your drug product.
QA / Regulatory
With MasterControl as our enterprise quality management system (eQMS), we have the infrastructure to support regulatory filings. Our team has extensive experience supporting FDA and EU drug submissions.
Shipping & Storage
With our 31,000 sq.ft. facility including warehouse space, expandable walk-in 4°C refrigerator, -20°C freezer, -80°C freezers, back-up generator and 24/7 security, we keep your product safe. Upon release we will ship to your required destination, worldwide.