Tuesday, March 4, 2014

How does one characterize critical quality attributes over the development lifecycle of an ADC?

We recently sat down with Biopharmaceutical Development and Production Week speaker Dr. Janet Wolfe, President and Chief Executive Officer, at Wolfe Laboratories to get a preview of her session later this month.

Janet started out by answering:
How does one characterize critical quality attributes over the development life cycle of an ADC?

So, one really needs to think about the development lifecycle and break it into parts and say that this is an example of two, three different stages.

At the discovery stage, one would have very limited material and in an antibody drug conjugate, there are a number of different variables that need to be considered – the antibody, the linker, the payload, the conjugation chemistry, the reaction in which its run and the formulation. All of these variables mean that a lot of different conditions need to be explored to identify what the molecule is that is going to be taken forward. As a result, there are always going to be limited amounts of antibody link or payload materials that are available.

So, one needs to have a high-throughput process, as well as a material starting approach so that one could rank order these resultant ADCs. And that rank ordering requires understanding what critical quality attributes might be at the discovery stage. Now in contrast, in the early development stage one needs to shift one’s focus and to look at more of a reasonable production process for the selected combination of antibody linker and payload and then identify what the formulation is going to be. Material availability becomes less of an issue and while time is always of the essence, it is also less of an issue because you’re focusing on the single molecule. So, what one will do at that point is develop the number of QC assays, as well as biophysical techniques that will identify what the problem spots are on the molecule and in a specific formulation.

Now, at the later stage when one is going into production, the focus shifts yet again. The molecules have been identified, the formulation has been identified and the focus shifts to controlling the production and the process. So, it requires that there are quality control tests and biophysical techniques that demonstrate comparability as one makes the product. These techniques are then also used to support stability studies.
So, as you consider the development lifecycle of an ADC, one needs to consider not only the molecule itself, but also the stage at which you are working because your focus is going to shift.

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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