So when do you start Quality by Design?

September 12th, 2011 by

After participating on a panel discussion at an IBC conference on Quality by Design (QbD) and the new Process Validation guidance issued earlier this year by FDA, I was approached by a process development scientist who asked my advise on the value of implementing  QbD in their company.

He explained that his company was extremely small and did not have a a large number of staff in his discipline or even other related ones such as quality and manufacturing.  In fact, he indicated that the clinical manufacture would be 100% outsourced. However, they were entering phase 1 soon and he was afraid to miss the opportunity to incorporate this new approach into their process development activity.

Over the next 20 minutes of discussion, the following points were raised which led to the following conclusions:

1.)  He was using a platform technology for the process to make clinical materials.
This platform would not be the process that they would commercialise by.  Therefore spending a lot of resources homing in on the role of inputs (raw materials), control points and control strategies did not make sense at this stage.  However, developing a set of critical quality attributes for the product did.  This would serve as a spring board
as they begin to develop their phase 3 process which would be the commercial one later in the cycle.  This commercial process may not look at all like the early clinical stage product.

2.)  These critical quality attributes would be important to have as early as possible for the drug product and the active pharmaceutical ingredient at least. This was particularly true for the biological product they were developing and would also be applicable to small molecular weight products as well.

This gave him quite a bit of relief that he had some time to work through the details before rushing headlong into the activity.

There was a question I posed to him that got him thinking and that was. “You are working for small company, highly outsourced.  Is you business model to take this product to market yourself or with a partner?  Or perhaps to get Phase 1/2 data and sell the product to a big Pharma?”

He responded “Why would it matter?”

“Because if you take it to market with or without a partner, you will need to begin the work on QbD as soon as you start the Phase 3 process development.  If you plan to sell it, the buyer will want to develop the process and they will do the QbD.  Any Phase 3 process work you do may not be valued by the buyer as much as the product, so your ROI on this work may not be as much as that for the product.”

So the take home messages are:  know your business model for your company and be sure to consider the ROI on the work you put into your product and processes.

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