QbD is Coming! 05/02/2016 17:43 Good news of course. A quality driven understanding of every aspect of your process will assure a higher standard of drugs, treatment and diagnostics. But with it comes the need to evaluate, understand and control the sources of degradation, variability and inefficiency at every step in your process. With estimates claiming that one out of three clinical errors originate from preclinical handling errors, heavy scrutiny will undoubtedly be applied in these areas. Thawing has long been overlooked as a source of such errors. Yet recent studies reveal what we all could have guessed: Degradation and variability can be introduced through haphazardly transitioning samples from deep freeze to working temperatures. Both time and temperature have a range of measurable impacts. Using water baths can introduce pathogens and contamination. Furthermore they introduce random and potentially harmful heat cycles in the process of trying to hold in a bath full of frozen samples at set temperature. Heat blocks pose similar risks. And the old "tube in the pocket" method, well, that's not going to make the cut either.
