Within the small molecule field, there are typically large differences between Drug Substance (DS) and Drug Product (DP). However, given the biological origin of the therapeutic material used for Cell & Gene Therapy (CGT), are there any significant differences between the DS and DP in this case, other than the fill and finished process DS goes through to become the DP?
Thank you very much in advance.
Hello Sergio Lainez Vicente
There should not be much difference between Drug Substance (DS) and Drug Product (DP) as far as cell and gene therapy is concerned. The Drug Substance (DS) development includes the master and working cell bank development, manufacturing process development under GMP, and scale-up; and the Drug Product (DP) development, could include the filling of the drug substance into the primary container. If the primary container is a medical device, such as a prefilled syringe, then there is an additional step where the final drug product is placed into the final packaging tray or system to form the final combination product. In some cases, the last step may consist of formulation and filling of the drug product.
Best.
Hi Malcolm,
Thank you very much for your answer. Your very last sentence is the one that I am really interested at. If the DS is used for all the preclinical work and typically part of the clinical trilas, adding a "formulation" step to get the DP would raise regulatory concerns, since thre would be differences between the DS and DP ans therefore, some testing may be required, right?
Hi Sergio,
You could refer to the link below under the heading Drug Substance and Drug Product. This would perhaps answer your question.
https://clarkstonconsulting.com/insights/fda-gene-therapy-guidances/
Best.
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