Characterization of the transgenic production process should initially focus on:
1) The presence of known and potential human pathogens, (both adventitious and endogenous agents) in the source material.
2) The amount of immunogenic and toxic materials in the final product,
3) The batch-to-batch consistency of the products physicochemical propreties.

6-4.3.5 Batch release testing of the final product:

The purified product prior to final formulation should be characterized in a manner similar to other recombinant products. Contaminant levels in the final product that are acceptable for product release will be determined by preclinical studies, the dose and route of product administration, frequency and duration of product administration and the proposed patient population for the clinical study.

6-4.3.6 Preclinical safety evaluation

If there is similarity between the product and the naturally occurring molecules, it may still require limited toxicology studies. In vitro studies in animal models may be used to examine product efficacy and safety.

6-4.4 Application of Transgenic Animal Biopharming

6-4.4.1 Biomedical application:

To overcome the limitations of conventional recombinant production system of human therapeutic proteins, transgenic animals have been developed as bioreactor. 

6-4.4.1.1 Therapeutic protein production:

Several human therapeutic proteins were produced using transgenic livestock as bioreactor. Low cost, higher level of production and easy downstream processing make transgenic animal a better alternative to conventional production system. Table 6-4.4.1.1shows examples of some therapeutic proteins produced using transgenic animals.