EXEGEN PKD MINISWINE- ppkd-blast excised not applicable 
Exemplar Genetics, Llc

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pPKD-Blast in miniswine

ExeGen PKD miniswine

ExeGen PKD miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pPKD-Blast which exhibit similar phenotypes to human patients with PKD. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization and the carcasses and all materials generated from these animals will be destroyed by incineration.

Product Definition: A specific line of Yucatan miniature pigs (Sus scrofa domesticus), including heterozygous offspring resulting from a heterozygous founder, in which the PKD1 gene has been disrupted by the homologous recombination of a single copy of a mutated PKD1-PGK construct resulting in a point mutation for use in biomedical research. The desirable animal will be a heterozygote PKD1 +/R3277C Blast miniswine.

Warning: This product is from a genetically engineered animal and may contain an investigational new animal drug. It is for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration. In case of emergency or release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.

warning label

EXEGEN PKD MINISWINE 
ppkd-blast excised not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2002
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HETEROZYGOUS YUCATAN MINIATURE PKD MUTATED GENE DISRUPTED BY A PKD-BLAST RDNA CONSTRUCT RESULTING IN MUTATION R3278C (UNII: E3SP91Q3EF) (pPKD-BLAST Excised - UNII:E3SP91Q3EF) HETEROZYGOUS YUCATAN MINIATURE PKD MUTATED GENE DISRUPTED BY A PKD-BLAST RDNA CONSTRUCT RESULTING IN MUTATION R3278C1 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-2002-11 [arb'U] in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2020
Labeler - Exemplar Genetics, Llc (958331121)
Registrant - Exemplar Genetics, Llc (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics, Llc958331121manufacture

Revised: 2/2020
Document Id: 9237a8ba-a25b-4b01-804d-0d1c08209016
Set id: be7fe49c-ba35-4218-b828-ec10e71e9ec8
Version: 1
Effective Time: 20200212
 
Exemplar Genetics, Llc