BC6 RDNA CONSTRUCT ON CHROMOSOME 5Q3.4 IN 155-92 GOATS by LFB USA, Inc. Bc6 rDNA
BC6 RDNA CONSTRUCT ON CHROMOSOME 5Q3.4 IN 155-92 GOATS by
Drug Labeling and Warnings
BC6 RDNA CONSTRUCT ON CHROMOSOME 5Q3.4 IN 155-92 GOATS by is a Other medication manufactured, distributed, or labeled by LFB USA, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
BC6 RDNA CONSTRUCT ON CHROMOSOME 5Q3.4 IN 155-92 GOATS- bc6 rdna construct on chromosome 5q3.4 in 155-92 goats not applicable
LFB USA, Inc.
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Bc6 rDNA
Bc6rDNA CONSTRUCT ON CHROMOSOME 5q3.4 IN 155-92 GOATS
LFB USA, Inc.
Bc6 rDNA Construct on Chromosome 5q3.4 in 155-92 Goats
Heritable construct
1. DESCRIPTION
Bc6 rDNA construct integrated at a single site on chromosome 5q3.4 in a specific diploid line (155-92) of hemizygous and homozygous domestic goats (Capra aegagrus hircus) derived from the founder animal 155-92 directing the expression of the human gene for antithrombin in the mammary gland such that recombinant protein is present in the goat milk to enable purification of recombinant rhAT.
2. WARNINGS AND PRECAUTIONS
The 155-92 goats, or any materials derived from the 155-92 goats, are not intended to enter the human or animal food supply.
3. EFFECTIVENESS
Multiple generations of the 155-92 goats have demonstrated genetic stability as established through genetic tests for the presence of the Bc6 rDNA construct, Bc6rDNA sequence fidelity, and Bc6 construct integration site consistency. For each generation, phenotypic stability has been established based on the presence of recombinant antithrombin in the milk of the goats.
4. ANIMAL SAFETY
The health monitoring program for the goat population at the LFB USA facility follows standard operating procedures. The testing program characterizing the specific diseases and frequency that all the goats are tested for in the 155-92 genetically engineered (GE) and the general herd is listed in Table 1. Established procedures govern action and any follow-up response to the CVM in the event of confirmed positive results for agents on the Specific Pathogen Free (SPF) exclusion list.
Table 1. Testing On All Goats
| Disease | Testing Frequency |
| Caprine arthritis encephalitis | Annual – 10% Entire herd > 6 months of age |
| Johnes (ELISA) | Annual – 10% Entire herd > 6 months of age |
| Brucellosis | Annual – 10% Entire herd > 6 months of age |
| Neospora | Annual – 10% Entire herd > 6 months of age |
| CapHV-1 | Annual – 10% Entire herd > 6 months of age |
| Johnes (Culture) | As follow-up test to ELISA ≥ 2.0 only |
| Contagious ecthyma (Orf) | For cause testing |
| Ileo-cecal Valve | 10 % of animals > 6 months of age that are culled or die |
| Mesenteric Lymph Node Collection | 10 % of animals > 6 months of age that are culled or die |
Quarterly morbidity and mortality summaries are prepared and evaluated based on daily health observations of the 155-92 goat herd. The morbidity (see Table 2) and mortality (see Table 3) tables provide a data summary for the 155-92 GE goats and and all other goats at the facility.
Table 2. Quarterly Morbidity Summaries 2019 - Prevalence'
1Prevalence is expressed as a percentage of the rolling population (total number of animals) for a particular quarter.
22019 Q3 for Bc6 rCDA was a result of diarrhea cases due to animals escaping pen and ingesting grain free choice.
Table 3. Quarterly Mortality Summaries 2019 - Prevalence'
1Prevalence is expressed as a percentage of the rolling population (total number of animals) for a particular quarter.
| BC6 RDNA CONSTRUCT ON CHROMOSOME 5Q3.4 IN 155-92 GOATS
bc6 rdna construct on chromosome 5q3.4 in 155-92 goats not applicable |
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| Labeler - LFB USA, Inc. (079488639) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LFB USA, Inc. | 079488639 | analysis | |
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