How is clinical manufacturing different from commercial

September 10th, 2012 by

At a recent webinar presented by Tungsten Shield on the topic of the differences between Clinical Manufacturing and Commercial, one question perplexed me.  It went something like this:

You advocate using less resources to release a commercial lot of material than a clinical lot and you point to Risk Management techniques.  Surely, the commercial lot represents more value to the company and so shouldn’t you spend more resources?

My response went this way.

In the case of a commercial product where you are making the product round the clock, turning out perhaps a 100 lots a year, you expect operations or manufacturing to be highly experienced in making the product.  They have tremendous experience.  They should not be making mistakes.  The QA department are seeing lot packages continuously and know the weak points and strengths of the process, departments testing etc so know where the risks are.  Now the clinical lot, is probably very unique, maybe only made once and never the same twice since the process is changing.  Similarly, the testing is evolving. The documentation is changing and evolving.  So we do not have the history with the material. Add to that the lack of knowledge about the product particularly in early phase.  All of these add up to a higher risk of issues especially to the patient.  While the commercial lots do represent high value to the company, the clinical lots represent the future for the company where errors can result in products not making it through the clinic or causing delays in clinical programs and let’s not forget the impact on patients.

The questioner seemed fine with the response.

Leave a Reply

Your email address will not be published. Required fields are marked *