EDITORIAL
Quality Control in Biotechnology As noted in several previous editorials, ANALYTICAL CHEMISTRY
has initiated
an effort to encourage greater involvement of our readers in the emerging field of analytical biotechnology. Our goal is to stimulate greater participation in the field by analytical chemists and to encourage those scientists in the field of analytical biotechnology who are publishing elsewhere to contribute research papers to our J O U R N A L . To assist in this ambitious task, we appointed (in 1987) John Smith of the Harvard Medical School as our first associate editor in the area of analytical biotechnology. In July 1988 he was succeeded by Walter C. Herlihy, vice-president and director of research of the Repligen Corporation in Cambridge, MA. In this issue, we begin a new series of articles entitled "Perspectives" that is initially intended to highlight important ! areas in analytical biotechnology. The first, by R. L. Garnick, N. J. Solli, and P. A. Papa of Genentech, Inc. (San Francisco, CA), is entitled "The Role of Quality Control in Biotechnology: An Analytical Perspective." The use of living organisms for the manufacture of pharmaceutical products and the complexity, size, and structure of these products are presented as
the underlying reasons for the significance of quality control in the evolving biotechnology industry. Because of the uniqueness of the industry, along with stringent regulatory conditions imposed by the Food and Drug Administration, analytical methods applied to quality control procedures play a critical role in biotechnology. The authors point out that the quality control of biotechnology products is somewhat different than quality control of traditional products because it is dictated not only by the production process but by the product itself. Quality control systems must be capable of providing lot-to-lot consistency, purity, and stability to ensure the safety of the product. The authors review the fundamentals of biotechnology along with the analytical systems currently in use, emphasizing the need for further development in analytical methodology. This first perspective represents an excellent start in our campaign for greater involvement in the biotechnology field by members of our analytical community.
ANALYTICAL CHEMISTRY, VOL. 60, NO. 23, DECEMBER 1, 1988 · 1319 A
