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Article Title

Regulatory aspects of living biological material

Abstract

Any living biological material is, in effect, a biotechnology factory complete with sophisticated process designs and its own source of venture capital. Biotechnology is the application of living material and its process system to obtain useful products or services. It is not limited to the recent developments in recombinant DNA techniques, monoclonal antibodies, and related processes and products, aspects with which it is most often identified, but includes the manufacture of nonrecombinant biological material, such as microorganisms and plants and animals from traditional breeding methods; biologically active compounds; and a variety of foods and drugs. Due to complex economic, social, and technological changes, biotechnology is in a state of transition from a knowledge-building science to a new industry. Among the many issues and concerns contributing to this is the emergence of ownership and intellectual property rights of biological material. Since the biotechnology industry is becoming increasingly global in nature, competition in world markets requires that special attention be paid to regulations concerning deposit requirements for patent purposes, transfer agreements, and the packing and shipping of biological material, both nationally and internationally.

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