EXEGEN CLN2 MINISWINE- pcln2-blast excised not applicable 
Exemplar Genetics LLC (dba Precigen Exemplar)

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pCLN2 in miniswine

ExeGen CLN2 miniswine

ExeGen CLN2 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN2 which exhibit similar phenotypes to human patients with CLN2 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 and heterozygous offspring resulting from a heterozygous founder, in which the CLN2 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN2-PGK construct in exon 6 for use in biomedical research. The desirable animal will be a homozygote CLN2 R208X Blast Excised/R208X Blast 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 CLN2 MINISWINE 
pcln2-blast excised not applicable
Product Information
Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86093-2004
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE (UNII: 6J81TO7Z9U) (CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE - UNII:6J81TO7Z9U) CLN2 RDNA CONSTRUCT DISRUPTING EXON 6 OF CLN2 GENE IN YUCATAN MINIATURE SWINE1 [arb'U]  in 1 [arb'U]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86093-2004-11 [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: 4/2020
Document Id: 98381d6d-2abc-4a58-bf50-659925f594e6
Set id: 89d301a6-fc07-488d-876d-bccf92995d3f
Version: 2
Effective Time: 20200413
 
Exemplar Genetics LLC (dba Precigen Exemplar)