Argonaut Manufacturing announced the California Department of Public Health, Food and Drug Branch (FDB) has inspected and approved Argonaut’s 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 fill/finish line complements other Argonaut drug services including formulation and a full suite of onsite analytical support.
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“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.”