ABSTRACT
Macromolecules derived through biotechnology are expected to challenge the immune system of the laboratory animal used for toxicological testing protocols. Although biotechnology has been used for centuries, only has it been applied to more complex molecular structures such as in the genetic manipulation of both plant and animal cells. The introduction of transgene technologies, which involve the transfer of a gene from one species to another species, has occurred along with other advances in recombinant deoxyribonucleic acid methodologies or genetic engineering. The creation of laboratory mouse models for biomedical research has progressed rapidly, and so-called designer mice are being used to study immune deficiencies, cancer, and developmental biology. Historically, the regulatory approval of genetically engineered products has varied widely. The safety and regulatory approval of therapeutic proteins has generally proceeded without any major impediments. Several countries have well-established regulatory groups for biotechnology-derived-drugs or therapeutic proteins.
