BC2371 RDNA CONSTRUCT ON CHROMOSOME 3P1.1-2 IN R69 NEW ZEALAND WHITE RABBITS not applicable

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

BC2371 RDNA CONSTRUCT ON CHROMOSOME 3P1.1-2 IN R69 NEW ZEALAND WHITE RABBITS (UNII: 00PR6AZ7SU) (BC2371 RDNA CONSTRUCT ON CHROMOSOME 3P1.1-2 IN R69 NEW ZEALAND WHITE RABBITS - UNII:00PR6AZ7SU)

Inapatikana kutoka:

LFB USA, Inc.

Njia ya uendeshaji:

NOT APPLICABLE

Matibabu dalili:

The R69 line of New Zealand white rabbits in the United States must be housed in only the LFB USA, Inc. facilities specified in the approved application. Manufactured by: LFB USA 175 Crossing Boulevard Framingham, MA 01702 Approved by FDA under NADA 141-511

Idhini hali ya:

New Animal Drug Application

Tabia za bidhaa

BC2371 RDNA CONSTRUCT ON CHROMOSOME 3P1.1-2 IN R69 NEW ZEALAND WHITE
RABBITS- BC2371 RDNA CONSTRUCT ON CHROMOSOME 3P1.1-2 IN R69 NEW
ZEALAND WHITE RABBITS NOT
APPLICABLE
LFB USA, INC.
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BC2371 RDNA
_BC2371_ RDNA CONSTRUCT IN R69 NEW ZEALAND WHITE RABBITS
LFB USA, INC.
_BC2371_ RDNA CONSTRUCT IN R69 NEW ZEALAND WHITE RABBITS, EXPRESSING
RECOMBINANT HUMAN
FACTOR VII (RHFVII IN THE MAMMARY GLAND).
Heritable construct
1. DESCRIPTION
A single copy of the rDNA construct (designated _Bc2371_) for human
Factor VII (hFVII) has been
integrated into the genome, on chromosome 3p1.1-2, of a specific,
diploid line (designated R69) of
hemizygous and homozygous New Zealand white rabbits (_Oryctolagus
cuniculus_). This rDNA construct
includes a chicken β-globin insulator sequence, the goat β-casein
promoter at its 5’ end, and the goat β-
casein sequences at its 3’ end. The integrated rDNA construct drives
the expression of the rhFVII
protein in the milk of R69 rabbits. The milk obtained from these
rabbits is processed in order to purify
and activate the rhFVII to rhFVIIa, which is then intended for use as
a therapeutic for human hemophilia
A or B patients with inhibitors to Factors VIII and IX.
2. WARNINGS AND PRECAUTIONS
R69 rabbits, or any materials derived from R69 rabbits, are not
intended to enter the human or animal
food supply.
3. EFFECTIVENESS
Multiple generations of the R69 line have demonstrated genetic
stability as established through genetic
tests for the presence of the _Bc2371_ rDNA construct, _Bc2371_ rDNA
sequence fidelity, and _Bc2371_
construct integration site consistency. For each generation,
phenotypic stability has been established
based on the presence of recombinant hFVII zymogen in the milk of R69
line rabbits.
4. ANIMAL SAFETY
The health monitoring program for the rabbit population at the LFB
USA’s facility follows standardized
operation procedures. The testing program characterizing the Specific
Pathogen Free (SPF) status of
the colony has been instituted based in part on the Federatio