FDB Approves Argonaut’s Facility

The California Department of Public Health, Food and Drug Branch (FDB) has inspected and approved Argonaut Manufacturing Services’ new Drug Product Manufacturing facility, permitting Argonaut to manufacture and ship pharmaceutical products. The FDB approval formally clears Argonaut’s new automated Bausch+Ströbel/SKAN isolator aseptic fill/finish line for clinical and commercial use.

On September 30, 2020, the FDB completed a comprehensive cGMP inspection of the facility with a clean report, no findings, and awarded Argonaut a license for drug product manufacturing. The Agency immediately notified Argonaut of the successful outcome of the inspection, with the approval to commence drug product manufacturing.

The Argonaut fill/finish line features:

• Minimal drug substance loss at the start and end of production.

• Reduced risk from particulates and human intervention.

• In-line, non-destructive 100% weight checks.

• Single-use disposable fluid path.

The fill/finish line complements other Argonaut drug services including formulation and a full suite of onsite analytical support.

“Argonaut’s focus is on providing drug product manufacturing services to innovative companies requiring the highest quality manufacturing for the sponsors and their patients,” said Eric Blair, chief commercial officer at Argonaut Manufacturing Services. “This expands our very successful business in Life Science, Diagnostic, and Medical Device and now opens our second business unit, focused specifically on Drug Product Manufacturing. We will be reinforcing our partnerships with drug substance providers such as Avid, and announcing large contracts to produce both clinical and commercial products. Our clients find Argonaut delivers premier service, support, and expertise in Biologics and high value drug product manufacturing.”

Argonaut provides Drug Product manufacturing with highly trained staff and experienced leadership, regulatory support, a full analytical laboratory, and storage services. The new facility also has capabilities beyond drug product manufacturing in the area of reagent kit manufacturing for Life Science and Molecular Diagnostic reagent production and global distribution. This includes combination products of medical device with parenteral therapeutics and drug substances.