hLAL rDNA Construct in SBC LAL-C Chickens by is a Other medication manufactured, distributed, or labeled by Alexion Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.
hLAL rDNA construct integrated at a single site (the SYN LAL-C site in chromosome 6) as a single copy, in a specific, diploid line (SBC LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus) derived from the lineage progenitor XLL 109, expressing a human lysosomal acid lipase (rhLAL) encoding gene such that rhLAL protein (intended for the treatment of humans) is present in their egg whites.
2. WARNINGS AND PRECAUTIONS
SBC LAL-C animals, or any materials derived from the SBC LAL-C animals, are not intended to enter the human or animal food supply.
Multiple generations of the SBC LAL-C line have demonstrated genetic consistency as established through genetic tests for the presence of the hLAL rDNA construct, hLAL rDNA DNA sequence fidelity and hLAL rDNA construct integration site consistency. For each generation, phenotypic consistency has been established based on the presence of recombinant human LAL enzyme activity in egg white.
4. ANIMAL SAFETY
Data from the following comparisons of SBC LAL-C to non-GE animals demonstrated a lack of adverse effect for the rDNA construct, or the recombinant human LAL protein, on the SBC LAL-C line:
|Avg. Weekly Mortality (%)||Standard Deviation||Range (%)|
|Overall for SBC LAL-C||0.45||0.40||0-1.74|
|LINE||18 Weeks of Age Body Weight|
|23 Weeks of Age Body Weight|
|28 Weeks of Age Body Weight
|Mean||Standard Deviation||Mean||Standard Deviation||Mean||Standard Deviation|
|SBC LAL-C Hens|
|SBC LAL-C Males|
|Hen Age (weeks)||25||30||35||40||45||50||55||60||65||70|
|SBC LAL-C Hens:|
|Non-GE Hens Facility 1||31||63||93||118||147||173||198||222||248||274|
The data for SBC LAL-C compared to non-GE animals demonstrates no significant differences in body weight, mortality, general health status or egg production.
5. LIMITATIONS OF USE
The SBC LAL-C line must be housed in only those Alexion Pharmaceutical, Inc. facilities specified in the approved application.
Alexion Pharmaceuticals, Inc.
33 Hayden Avenue
Lexington, MA 02421
[version 001 /2015]
|HLAL RDNA CONSTRUCT IN SBC LAL-C CHICKENS
hlal rdna construct in sbc lal-c chicken not applicable
|Labeler - Alexion Pharmaceuticals, Inc. (789359510)|