Tips and Tricks

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

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

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, Tips and Tricks|

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, Tips and Tricks|

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, Tips and Tricks|

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, Tips and Tricks|

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 [...]

Variabilization: Pivotal in your Biotech Reagent and Diagnostic Operations

By |October 30th, 2017|Cost, Operations, Tips and Tricks|

The concept of variabilization, a willful shift from fixed to variable costs, has been around since the late 1990s. First-in-class companies have moved from a fixed cost model to a variable model, primarily to enhance their agility, responsiveness, a [...]

Learn how to keep your manufacturing train from derailing

By |May 23rd, 2017|Manufacturing, News and Announcements, Tips and Tricks|

This animated video explains how biotech and diagnostic companies can reduce manufacturing risk while getting to market faster. The manufacturing journey doesn't have to be hard. If you want reagents, made right, watch this video. Want to learn more [...]