EXEGEN LDLR MINISWINE- pldlr-neo not applicable 
Exemplar Genetics, LLC

----------

pLDLR-Neo in miniswine

ExeGen LDLR miniswine

ExeGen LDLR miniswine are genetically engineered yucatan miniature swine containing the rDNA contruct pLDLR-Neo which exhibit similar phenotypes to human patients in which the same LDLR gene is non-funtional. Phenotypes include severely elevated serum cholesterol (total cholesterol and LDL) and atherocsclerosis. These pigs are intended to be used as large animla models of human disease. We will not be requesting a food use authorization and the carcasses and all materials feneated from these animals will be destroyed by incineration.


Product Definition: A specific lin of Yucatan miniatue pigs (Sus scrofa domesticus), indlucing both homozygous and heterozygous offspring resulting from a heterozygous founder, in which the LDLR (low-density lipoprotein receptor) gene has been disrupted by the homologuous recombination of a single copy of a pLDLR-Neo contruct in exon 4, for use in biomedical research.


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 ro 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 LDLR MINISWINE 
pldlr-neo not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-1901
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
YUCATAN MINIATURE PIG LDLR GENE DISRUPTED BY A LDLR-NEO RDNA CONSTRUCT IN EXON 4 (UNII: D2J8YIK6U6) (pLDLR-Neo - UNII:D2J8YIK6U6) YUCATAN MINIATURE PIG LDLR GENE DISRUPTED BY A LDLR-NEO RDNA CONSTRUCT IN EXON 4 1 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-1901-11 [arb'U] in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/05/2019
Labeler - Exemplar Genetics, LLC (958331121)
Registrant - Exemplar Genetics, LLC (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics, LLC958331121manufacture

Revised: 8/2019
Document Id: e112edb7-aa72-4bb0-b51d-1cabaae74148
Set id: 55dba434-9a73-4693-96b2-0074b2add069
Version: 5
Effective Time: 20190830
 
Exemplar Genetics, LLC