Argonaut Manufacturing Services Receives FDB Approval for Aseptic Drug Product Fill/Finish of Sterile Injectable Drugs
Carlsbad, California – Argonaut Manufacturing Services (‘Argonaut’) today announced the California Department of Public Health, Food and Drug Branch (FDB) has inspected and approved Argonaut’s state-of-the-art 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 is the newest and most advanced, particularly on the west coast of the United States, featuring:
- 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.”
The FDB approval for aseptic drug product fill/finish expands our very successful business in Life Science, Diagnostic, and Medical Device
Argonaut provides state-of-the-art 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.
Argonaut welcomes questions about how these new capabilities and the FDB Approval for Aseptic Drug Product Fill/Finish can impact pre-clinical to commercial product development plans. For more information contact us.
About Argonaut Manufacturing Services
Argonaut Manufacturing Services is an FDA registered, FDB approved, ISO 13485:2016 cGMP contract manufacturing organization dedicated to providing custom manufacturing and supply chain solutions for life science, molecular diagnostics, and biopharmaceutical companies. Life sciences and molecular diagnostics services include formulation, filling, lyophilization, and kitting, while biopharmaceutical services feature state-of-the-art automated aseptic fill-finish equipment for sterile injectable drugs. All projects are supported by a senior project management group, full analytical quality control service offering and global shipping logistics. From procurement through distribution, Argonaut provides a wide range of flexible solutions for diverse outsourcing needs. www.argonautms.com
Pharmaceutical Outsourcing: “Argonaut Manufacturing Services Receives FDB Approval for Aseptic Drug Product Fill/Finish of Sterile Injectable Drugs”