Bc6 rDNA Construct in LFB USA 155-92 Goats

Bc6 rDNA 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

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 (Cap r a 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.  

The 155-92 goats, or any materials derived from the 155-92 goats, are not intended to enter the human or animal food supply.

Multiple generations of the 155-92 goats have demonstrated genetic stability as established through genetic tests for the presence of the Bc6 rDNA construct, Bc6  rDNA 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.

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

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'

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'

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.

The 155-92 goats in the United States must be housed in only the LFB USA facility specified in the approved application.

Manufactured by:
LFB USA, Inc.
175 Crossing Boulevard
Framingham, MA 01702

Approved by FDA under NADA 141-294

Not Applicable