First Pass Yield or Quality Yield, Wait… What’s the Difference?
Manufacturing-related quality statistics aren’t normally associated with biorepositories, but the world of statistical process improvement tools can be very useful for biobanking. One such case is the difference between two basic statistical metrics — Quality Yield and First Pass Yield. I'd like to shed some light on both metrics starting with their definition, then propose a recommendation of which to use in a biorepository setting, and conclude with a proposed performance target level.
First Pass Yield vs. Quality Yield
Quality Yield (QY), also known as Final Yield (FY)1 represents the acceptable pieces at the very end of a process divided by the original number of pieces fed into the process. In a manufacturing setting, this tells you the overall proportion of acceptable results; if the number of units of acceptable quality at the end of the process is the same as what can be expected given what is fed into the process, then you have achieved a 100% Quality Yield.1
Topic: Biobanking and Biorepository, Topic: Qualif..........
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