In this n-Lorem podcast episode, Bottling Hope, host Stan Crook introduces guest Wayne Woodard, CEO of Argonaut. Wayne details his background in industrial technology, emphasizing the importance of operational roles in the supply chain. He then reveals factors that connect the growth of the electronics manufacturing industry with maturing phases in the diagnostics and life sciences sector, and how Argonaut contract manufacturing fits in this new type of ecosystem.
Sterile Fill Finish and GMP
In the n-Lorem podcast episode Stan and Wayne elaborate on the extensive process of drug discovery and development, illustrating by using the creation of an antisense oligonucleotide (ASO) in animal trials, to the critical stage of Good Manufacturing Practices (GMP) production, to the manufacture of a drug fit for clinical usage.
Wayne further delves into the process of Sterile Fill Finish, a process that takes place inside an automated isolator – a scaled-down robotic sterile environment, wherein the drug substance is filled into a vial, weight-checked for accuracy, stoppered, and completed. One step that is not automated is the final quality control where each vial undergoes visual inspection.
Emphasizing the focus on quality and patient safety, Wayne introduces Continuous Good Manufacturing Practice (cGMP) as a cornerstone of Argonaut. This ensures sterility and reduces the risk of endotoxins during the entire manufacturing process, resulting in the production of high-quality standards.
Stan goes on to thank Argonaut for their assistance in creating a streamlined process and that Argonaut donates potential profits, helping patients rather than improving commercial viability.
The podcast closes with a mention of Wayne’s involvement in the n-Lorem charity 5k walk, reaffirming his dedication to helping patients and further strengthening the bond between Argonaut and n-Lorem.
n-Lorem is a non-profit committed to providing personalized experimental treatments for patients with genetic diseases that affect one to thirty patients worldwide, often referred to as “Nano rare.”
How can Argonaut help you?
Argonaut serves the biopharma, life science, and molecular diagnostics industries, providing custom manufacturing and supply chain services for drug product aseptic fill & finish as well as for life sciences and in vitro diagnostics products with a spectrum of kitting capabilities. Argonaut is a leading provider of assay and reagent lyophilization services.
Contact us to learn more about how Argonaut can fill and finish your drug product.
Listen to the n-Lorem podcast episode here, or see this YouTube video: