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RE: cGMP grade Plasmid 

21-May-2019 12:00
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guidance - cGMP for phase 1 investigational drug.pdf   91 KB   1 version
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guideline on the preparation of IND products (human and a....pdf   795 KB   1 version
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21-May-2019 14:27

Thank you and I completely understand how cGMP is defined and completely agree with you; however gene therapy being so new, currently most companies are defining plasmids as a raw material and because there are so few companies that produce plasmids most companies until recently have been accepting use of research grade, highly documented plasmids, GMP-like plasmids but not actually fully compliant to cGMP. Scientifically, I don't agree that it is just a raw material since it is the  vector for coding the gene therapy. FDA recently released 6 new guidances on gene therapy but there is still nothing specific regarding compliance standards for plasmid.

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