A California-based CDMO has designed an aseptic filling line to maximise yield of expensive biologics and other high-value drug substances.
Photo as seen on Argonaut website
Argonaut Manufacturing Services, a biopharma CDMO, has launched its new aseptic vial filling services. The custom Bausch + Ströbel VarioSys filling line has been designed to maximise yield of expensive biologics and other high-value drug substances.
Argonaut worked closely with the Bausch + Ströbel engineering team to design an optimal filling line for biologics.
The new line uses engineering innovation to minimise residual API volumes and optimise weight checks.
Working with equipment manufacturer Bausch + Ströbel, the team designed a fluid path utilising a single-hose peristaltic pump attached to a single-use needle. This design minimises both the overall length and internal diameter of tubing, creating less area where API can be retained. Similarly, filters were sized and optimised to minimise dead volumes. This all minimises residual API volumes.
To minimise API lost to weight checks, Argonaut designed their filling line with in-line, non-destructive 100% weight checks. Every vial is tared before filling and actively measured during the filling process. This allows the vial fill volume to be automatically corrected instead of being discarded.
The company also focused on improving sterility, selecting isolator technology with fully automated robotics in order to combat known contamination sources. In comparison to cleanroom filling and older technologies, closed systems such as restricted access barrier systems (RABS) and isolators reduce contamination risk from the environment and personnel. Combining robotics with isolator technology further reduces human intervention, perhaps the greatest source of contamination risk in aseptic filling.
“As drug substance values continue to rise, we saw a need in the market for fill/finish service providers to adapt. Our line incorporates technologies designed to maximise yield and minimise risk, in order to safeguard every drop of API,” said Chris Duffy, COO of Argonaut.
Key line features include robotics, isolator technology, minimal hold up volume, and in-line non-destructive 100% weight checks.
Eric Blair, CCO of Argonaut, said: “The ADVANCEDFill technology our line features is ideal in the areas of rare disease, orphan drugs, and other small-batch biologics applications. Personalised medicine is driving an industry need for our services, as we have the ability to provide the small batch throughput and near zero-loss yield needed for precious drug substance.”
Argonaut begins serving clinical phase customers in Q1 2020.