Argonaut Manufacturing Services (‘Argonaut’), a leader in drug product and reagent kit manufacturing for therapeutics, life science and molecular diagnostics, today announced the successful completion of their first cGMP run. This news comes soon after the announcement that the Department of Public Health, Food and Drug Branch (FDB) had inspected and approved Argonaut’s state-of-the-art new Drug Product Manufacturing facility, permitting Argonaut to manufacture and ship pharmaceutical products. This formally cleared Argonaut’s new automated Bausch+Ströbel/SKAN isolator aseptic fill/finish line for clinical and commercial use.
The fill/finish line complements other Argonaut drug product services including formulation, and a full suite of onsite analytical support. With cGMP, FDA registration, and CFR820, 210, 211 and ISO 13485:2016 certifications, Argonaut’s team has the experience in drug product manufacturing for both clinical and commercial stage programs. Facilities include over 8000 sq.ft. of clean room (ISO 7&8) with all operations integrated into a validated enterprise quality management (EQM) system.
“Following approval by the FDB, we were able to quickly and efficiently complete our first cGMP run. The client came to us via Avid Bioservices, Inc, a key drug substance provider and a valued Argonaut ecosystem partner. The client was pleased with the availability in our schedule, the performance of our advanced fill/finish line, and the collaborative approach of our experienced team members. New clients can look forward to the same high quality fill/finish of their valuable product as well as effective communication throughout the strategic partnership” said Eric Blair, Chief Commercial Officer at Argonaut Manufacturing Services.
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. For more information, visit www.argonautms.com