As we approach the second half of 2008, is your understanding of the industry buzz word, Quality by Design (QbD), better than it was this time last year?
Posted by: Gemma Burns in Quality by DesignHi my name is Gemma and I produced our Quality by Design track.
* Quality by Design * Process Analytical Technologies * Design Space * Systems Biology * Manufacturing Space * Quality Risk Management
With many of these concepts being relatively new to the biopharmaceutical industry one question that arose continuously throughout my research was:
How do all these fit together?
Harmonising these concepts is an extremely challenging task but it is one that I think industry are beginning to have to face. They know that the quality outcome must be designed into the process itself rather than relying on final product testing. This means that manufacturers are having to make larger investments earlier in the product life cycle during process development, in advance of approved commercial operations. It is clearly an important issue that, if implemented correctly could help to save valuable resources.
The single hottest topic from my research on Quality by Design was design space and upstream processing. What are the best ways to classify the parameters and control terminology? How does your company establish the appropriate design space during upstream processing and what are the advantages of this?
I hope that some of you will share your thoughts and discuss ideas for moving forward with process design and control.
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