Transgenic have been produced in a variety of animal species e.g., mice, rabbits, swine, sheep, goat, cattle, poultry, fish, amphibians, insects and nematodes to produce therapeutic proteins against osteoporosis, cystic fibrosis, hemophilia, malaria, arthritis, HIV etc. Transgenic animals have also been developed to produce monoclonal antibodies (therapeutic antibodies against disease proteins) which are used in vaccine development. Other than being used as bioreactor, transgenic animals are also used as disease models and for improving livestock.

6-4.2 Advantages of Using Transgenic Animal in Biopharming:

• Protein function and activity depends on the three dimensional structure achieved by post-translational modification. The post-translational modification machinery is absent in bacteria (like E. coli) and plants have significantly different machinery than animals. To produce complex human therapeutic proteins, nothing can be better than animal livestock.
  
  
• Animal pharming does not require constant monitoring and sampling.
  
  
• Animal pharming is cost effective as it does not require substantial plant machinery which has to be purchased and maintained otherwise.
  
  
• Purification of proteins from an animal’s secretary or excretory gland products (milk, body fluid, urine etc) is simpler.
  
  
• Scale-up of production of a recombinant protein is easier with animal livestock.

6-4.3 Purification and Characterization of Transgenic Product:

6-4.3.1 Product recovery from the transgenic animals:

Recovery can be done by milking, exsanguinations (process of blood collection), surgical excision of tissues, or other methods as applicable. The recovery procedure should be designed to maximize the safety, sterility, potency, and purity of the product. The collection facilities should be maintained at the best possible hygiene condition to reduce any contamination.

6-4.3.2 Quality of a production batch:

Monitoring the quality of the product and the manufacturing processes require the purity of the product to be determined at multiple points during the production process. The tests found to be most sensitive to changes in product structure and/or potency should be validated and then incorporated as part of the batch release protocol. Conditions and criteria by which a production batch is defined (e.g., animals used, batch size, collection storage times, the time before sterile filtering and acceptance criteria for source material and product pooling) should be provided.