Wednesday, March 5, 2014

Are there key critical quality attributes that can be identified early to inform developability and risk assessment?

Today, we continue our interview with Dr. Janet Wolfe, President and Chief Executive Officer Wolfe Laboratories.  Yesterday, she look at how to characterize the quality attribute over the development life cycle of an ADC.

Today, we look at:
Are there key critical quality attributes that can be identified early to inform developability and risk assessment?

Absolutely, there are key critical quality attributes. For any molecule, there are going to be a number of quality attributes. However, you really need to understand which ones will be most informative.

Now, antibody drug conjugates are very complex macro molecules. And there is a fine balance that is required to achieve the optimal chemical, colloidal and conformational stability. As always, you’re going to have to compromise a bit in each one of these traits to identify the most stabilized conditions. Aggregation tends to be a very common problem and it occurs by a lot of different mechanisms. So, what you need to do is understand what the underlying mechanisms are that are causing aggregation in a particular circumstance and then you can identify mechanistically a way to counter that degradation or aggregation mechanism from occurring. This is how one can approach formulation development, as well as process development, to stabilize the antibody drug conjugate.

Each molecule is going to have unique attributes, so it’s difficult to generalize and say: “Yes, these are the same key critical quality attributes every time.” But, as a class, antibody drug conjugates do share certain traits that can be evaluated. What I mean by that is if you consider a certain payload class, the payload will have --- for a given payload, it will have specific attributes that will be shown to be problematic or not for a specific type of antibody drug conjugate. However, if you change to a completely different molecule as a payload, the critical quality attributes can shift. So, that’s just an example of how changing one variable per payload can cause a shift in what your key critical quality attributes would be.

Throughout her interview, Janet also examines key critical quality attributes, manufacturing, and the discovery/development continuum.  Download her full interview here.

Janet will be presenting Key Attributes and Considerations for Developing Antibody Drug Conjugate Formulations on Thursday, March 27 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.

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