Biotechnology: Products work

Safety of Biotechnology Products

Medicines based on the application of recombinant technology are relatively new to the therapeutics industry. This chapter will focus specifically on purified and recombinant proteins, collectively termed protein therapeutic agents (Gallupi et al., 2001), used in the treatment of disease that are able to affect the growth or metabolism of cells in vivo. This rather broad definition includes pro...

Risk assessment of biotechnology products

A number of crop products generated by using biotechnology have been introduced to the marketplace. These biotechnology products have been carefully evaluated for their overall safety from an agronomic, environmental, performance, and equivalence perspective, and the safety of the newly expressed protein(s). One aspect of the safety evaluation is the question concerning potential allergenicity....

Biotechnology for porcine products and its effect on meat products

Recombinant DNA technology has provided a mechanism for large scale production of somatotropin (growth hormone). There is no question that exogenous administration of somatotropin (ST) to pigs significantly improves efficiency of growth and carcass composition. Microinjecting foreign DNA into the pronucleus of fertilized ova is the predominant method employed to produce transgenic animals. The ...

Managing the Analytical Lifecycle for Biotechnology Products

Biotechnology pipelines have demonstrated significant growth over the past decade, with many therapeutic candidates evolving in a single class of protein molecules: the monoclonal antibodies (MAbs). To develop such therapeutic candidates, a scalable drug development process must leverage in-house and industry-wide knowledge so biotechnology companies can address the economic and medical needs o...

1 Downstream Processing of Biotechnology Products