New Containers Protect Bulk Frozen Biopharmaceuticals
2019-04-10 09:39 Wednesday
The growing pharmaceutical industry has led to the development of new high-performance bags that address the mechanical and purity challenges faced by liquid biologics or vaccines that require cryogenic packaging. Gore Sta-Pure Flexible Freeze Container 86 ℃ below zero(123 °F) in the frozen maintain the integrity of the packaging, and as a result its durable design minimizes the damage caused by packaging failure.
The company claims the sterile bags can withstand temperatures found "at the equator of Mars", "at the South Pole" or "at the top of mount Everest".
How is that possible? After 5 years of development, the Gore Sta-Pure Flexible Freeze Container is made of a patented biocompatible fluoropolymer composite membrane with extremely low extractive capacity. In addition, the sterile bag itself is designed for extra strength.
Since biopharmaceuticals are not currently shipped to Mars, Antarctica or Everest, why do they need this? There are two reasons:
The first is the development trend of biological drugs, whose nature requires cold chain treatment to maintain stability and effectiveness. According to a 2018 Frost & Sullivan report, 49% of all new drugs and vaccines approved by the Food and Drug Administration (FDA) in 2017 were temperature-sensitive products.
The second reason is that the market tends to concentrate on active ingredients, which usually means shipping them in bulk to a single place to make the final drug. By doing so, sterile bags can speed up the distribution of key drugs (such as vaccines), allow the bulk of active ingredients to be packed into final drug containers in smaller sizes and improves the economics of the product.
Both trends mean there is a strong demand for packaging that can store and safely transport frozen biological drugs and vaccines.
But polymer-based packaging faces challenges at low temperatures, such as becoming brittle and fractured - causing costly damage and product losses. But trying to solve this problem by adding layer upon layer of packaging is expensive and inefficient. The Gore Sta-Pure Flexible Freeze Container can solve the above problem technically.