Key Factors in Choosing the Right Biotech Contract Manufacturer
This post lays out qualifying factors for choosing a biotech contract manufacturer, with a notable argument in favor of dedicated contract-manufacturing specialists over product companies selling excess capacity.
How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016
This post explains the FDA’s move to harmonize its Quality System Regulation (QSR) with the international ISO 13485:2016 standard, and how device companies can prepare.
How to Compare Biotech Manufacturer Quotes — What You Need to Know
This post explains how to make a true ‘apples-to-apples’ comparison of manufacturing quotes, since headline prices often hide meaningful differences in scope
Increasing Lyophilization Process Efficiency (Part 2 of a Series)
The second post in the lyophilization series, focused on the elements that drive process efficiency and how efficiency gains affect both cost and diagnostic device performance.
How to Overcome Your Protein Lyophilization Roadblocks
This is one of the more technically substantive lyophilization posts, focused specifically on the difficulty of freeze-drying proteins (enzymes and antibodies) and how to overcome it.
Do You Know the Silent Killer of Biotech Supply Chain?
This post frames capital depreciation as the ‘silent killer’ of biotech supply chains and argues that contract manufacturing neutralizes it by converting fixed costs to variable costs.
