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The role of standardization at the interface of product and process development in biotechnology

Author

Listed:
  • Annika Lorenz

    (Universiteit Utrecht
    Technische Universität Berlin)

  • Michael Raven

    (Technische Universität Berlin
    European School of Management and Technology)

  • Knut Blind

    (Technische Universität Berlin
    Fraunhofer FOKUS)

Abstract

R&D stands for Research and Development and while research is essential for new product development in biotechnology, the development and its integration with research (the transfer from research to development) is underexplored. Without efficient and successful process development, biotech companies would not sustain in the long run as process development is a necessary condition en route to industrial commercialization. Based on qualitative interviews with 31 biotech companies and experts, we test a framework with technological, operational and organizational boundary conditions influencing the transfer between product and process development. Our results uncover two additional dimensions: relational and market determinants. We further identify uncertainties in the transfer and investigate if standardization can mitigate these uncertainties and eventually facilitate the integration of product and process development. We find that standardization is a beneficial mechanism for successful integration of the front end of process development activities. The present investigation contributes to the understanding of standards as a knowledge and technology transfer instrument for complex and critical development activities.

Suggested Citation

  • Annika Lorenz & Michael Raven & Knut Blind, 2019. "The role of standardization at the interface of product and process development in biotechnology," The Journal of Technology Transfer, Springer, vol. 44(4), pages 1097-1133, August.
    • Handle: RePEc:kap:jtecht:v:44:y:2019:i:4:d:10.1007_s10961-017-9644-2
    DOI: 10.1007/s10961-017-9644-2
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    More about this item

    Keywords

    New product development; Process development; Biotechnology; Standardization; Integrated product development; Uncertainty;
    All these keywords.

    JEL classification:

    • L15 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Information and Product Quality
    • L23 - Industrial Organization - - Firm Objectives, Organization, and Behavior - - - Organization of Production
    • L65 - Industrial Organization - - Industry Studies: Manufacturing - - - Chemicals; Rubber; Drugs; Biotechnology; Plastics
    • O31 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Innovation and Invention: Processes and Incentives
    • O32 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Management of Technological Innovation and R&D

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