EXEGEN CLN3 MINISWINE- pcln3-neo excised not applicable 
Exemplar Genetics LLC (dba Precigen Exemplar)

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pCLN3 in miniswine

ExeGen CLN3 miniswine

ExeGen CLN3 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN3-Neo Excised which exhibit similar phenotypes to human patients with CLN3 disease. 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 homozygous offspring resulting from a heterozygous founder, in which the CLN3 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN3-PGK construct for use in biomedical research. The desirable animal will be a homozygote CLN3 Ex7-8del Neo Excised/Ex7-8del Neo Excised 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 CLN3 MINISWINE 
pcln3-neo excised not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2001
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE (UNII: E3SP91Q3EF) (CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE - UNII:E3SP91Q3EF) CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE1 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-2001-11 [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 (dba Precigen Exemplar) (958331121)
Registrant - Exemplar Genetics LLC (dba Precigen Exemplar) (958331121)
Establishment
NameAddressID/FEIBusiness Operations
Exemplar Genetics LLC (dba Precigen Exemplar)958331121manufacture

Revised: 1/2020
Document Id: 67171ff2-decc-4ad0-b57c-5c91f7a9782f
Set id: 20512e4e-c3ff-4025-be18-c634c3b6a49d
Version: 2
Effective Time: 20200115
 
Exemplar Genetics LLC (dba Precigen Exemplar)