A Systems Approach to Biotechnology Design Review


Zett, Mary L.   (1987, ASQC)   Ortho Pharmaceutical Corp., Raritan, NJ

41st Annual Quality Congress, May 1987, Minneapolis, MN    Vol. 41    No. 0
QICID: 3276    May 1987    pp. 58-64
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Article Abstract

The success and quality of biotechnology product development, in terms of effective transfer of technical information through the R&D program, may be facilitated by a systematic approach to design review -- a universal equation for excellence. Government regulatory guidelines, such as the guidelines for monoclonal antibody biological products by the Bureau of Biologics, provides us with the "unifying principle" for designing evaluation protocols for design review stages. There is a need for R&D facilitators to have working knowledge of government regulations and/or guidelines, as well as technical awareness of current technology.

Development team members must not only have strong technical and communication skills but a systematic review process that incorporates regulatory requirements at early prototype design stages. This smoothes the technical transfer of information, as well as builds the validity of experimental designs for product characteritzation and performance criteria.

The topic is approached by review of the current Guidelines for biotechnology. The system proposed provides a plan for technology transfer from research through product development into the marketplace. In each case, we will take the guidelines and translate them into a practical application as one would expect to use the regulatory information in a laboratory setting. The content of the presentation is technical to some extent. But the main thrust of the information is a management issue that emphasizes the regulatory aspect of developing a biotechnology product. Conformance to the Bureau of Biologics Guidelines makes good business sense and may save quality costs in the long term.

Results are presented as a case study of a development program for a monoclonal antibody reagent used in the enzyme linked immunoassay (ELISA) test systems. The universal equation of excellence is an integration of technical innovation and quality engineered design reviews backed by a working knowledge of regulatory requirements. The universal equation of excellence = a productive use of knowledge.


Research and development (R&D),Case study

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