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The Case for Qualification and Validation of Biological Material Storage and Transit Systems

How much is your lack of temperature control costing you? Too often vaccines and bio-therapeutics are destroyed because of improper storage and distribution. And lost inventory is only the beginning of the true cost of not maintaining cold chain. Meeting ever more stringent regulatory requirements will become more difficult without taking the steps needed to qualify or validate your storage and transit systems. If you get 99 percent of your cold chain right but miss on the final 1 percent, you still fail, especially where cell-based products are involved. And the reason is most likely excess complexity, which is especially true for managing newer biologics such as an autologous cell therapy that requires the patient's sample to formulate the final therapeutic agent. 

Topic: Qualification / Validation, Content: Blog

Qualification and Validation Webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics

As cold chain and ultra cold chain logistics have become an increasingly important element in the shipping of high volume medical, biologics, and other critical biological materials. The need to create an effective strategy to ensure packaging integrity has become a topic of great interest. 

Topic: Qualification / Validation, Content: Webina..........

Cold Chain Qualification : 5 Questions You Must Ask When Shipping Biologics

“Cold Chain” refers to the uninterrupted series of logistical activities (packaging, shipping, storage, distribution, handling) of products that must be maintained within a given temperature range. And as those of us in the bio-pharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products.

Topic: Qualification / Validation, Content: eBook