With a loaded 2020, it was easy to miss events close to home that can impact your business. Here are two top milestone developments in Drug Discovery services at Argonaut. With these milestones completed, sterile fill/finish in one of the most advanced facilities is now ready for your small molecule project.
Along with the sterile fill/finish milestones, did you catch our most popular post of the year, “Bringing Manufacturing Back to the US”? This post made the rounds on LinkedIn, generating praise while cutting against conventional wisdom. Check it out below.
Successful completion of the first cGMP run
In October, we completed the first successful cGMP run soon after the new automated Bausch+Ströbel/SKAN isolator aseptic fill/finish line was cleared for clinical and commercial use. With cGMP, FDA registration, and CFR820, 210, 211 and ISO 13485:2016 certifications, support for clinical and commercial stage programs is in full swing!
Look back at Argonaut’s first cGMP run here.
FDB Approval for Fill/Finish of Sterile Injectable Drugs
Earlier this year, the site was thoroughly inspected by the California Department of Public Health Food and Drug Branch (FDB) and approved for the manufacturing and shipping of pharmaceutical products. With a clean report and not a single finding, we were awarded a license for drug product manufacturing in September.
Read all about the FDB approval here.
Bringing Manufacturing Back to the US
Look back at CEO Wayne Woodard’s take on the renaissance of American manufacturing and take a deeper look at why arguments like cost savings and ease of offshoring manufacturing may not hold up. There is no arguing that countries that attract companies to their shores realize the value of the investments needed to maintain a manufacturing sector in their economies.
Read what it takes to return drug and diagnostic manufacturing to the US here.
You can check out all Argonaut’s news and blogs for 2020 here.
We’d like to hear from you. What would you like to read about from Argonaut in 2021? Leave your thoughts here.
