When is the Right Time to Select a Biotech Contract Manufacturer (CMO)?

By |October 22nd, 2019|Manufacturing, Useful Tips|

Every journey to contract manufacturing is unique. Some biotech companies know, at the start, they want to work with a contract manufacturing organization (CMO), while others choose to engage a CMO later in the product design process or even after pr [...]

Make Versus Buy: Evaluating your Aseptic Fill/Finish Manufacturing Strategy

By |October 9th, 2019|Drug Product Manufacturing, Useful Tips|

Every biopharma company is eventually faced with the “make versus buy” decision – should they fill/finish their drug product in-house or outsource? Complicating things further, a third option also exists to outsource a portion while retaining some i [...]

Scale-up and Automation Strategies in Life Science Manufacturing

By |September 17th, 2019|Manufacturing, Useful Tips|

Scale-up and automation in life science manufacturing is challenging. When picturing a manufacturing line, you likely conjure up images of automated multi-function equipment or deft robotic arms. However, for the vast majority of life science compani [...]

How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016

By |June 26th, 2019|Certifications, QA/QC, Useful Tips|

For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food and Drug Administration (FDA) has considered their Quality System Regulation (QSR) to be the minimum criteria for medical device manufacturing since [...]

Your Guide to Outsourcing Reagent & Assay Lyophilization

By |January 2nd, 2019|Lyophilization, Manufacturing, Useful Tips|

Upgrading your reagent or assay with lyophilization offers many advantages, but it can be difficult knowing how to start the process. At Argonaut we work with a wide range of clients, from the smallest startups to the largest biotechs. While these co [...]

Three Reasons Why Lyophilized Beads are the Next Big Thing in Assay Design

By |December 12th, 2018|Lyophilization, Useful Tips|

With multiple benefits including cost savings and reduced environmental impact, it is no wonder that companies are moving toward lyophilized beads in their product lineup. Bead-format lyophilization has significant advantages over traditional lyophil [...]

Key factors in choosing the right biotechnology contract manufacturer

By |May 1st, 2018|Manufacturing, Supply Chain, Useful Tips|

Choosing the right contract manufacturer to partner with is critical for your business success. Get it right, and a good contract manufacturer relationship gives you superior supply chain leverage. Choose the wrong contract manufacturer and you risk [...]

Looking to Gain Value in Your Drug Product or IVD? Level-Up Your QC Program

By |February 8th, 2018|Cost, QA/QC, Useful Tips|

Many organizations view their QC program as a necessary evil- required by regulatory bodies and useful primarily to release product. However, defining and building a solid Quality Control program can unlock great value. Setting aside the need for fin [...]