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Product and Process Innovation in the Development Cycle of Biopharmaceuticals

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Abstract

Purpose

The biopharmaceutical market has shown continuous growth under the intensive focus of the pharmaceutical industry. The processes for R&D and production of biopharmaceuticals are significantly more complex compared to those associated with small-molecule drugs. The complex structures of protein molecules make achieving successful development while meeting quality requirements challenging. We aimed to elucidate differences in patterns of product and process innovations between the biopharmaceutical and chemical-based pharmaceutical industries.

Methods

We tracked, categorized, and compared patented pharmaceutical and biopharmaceutical technologies along development cycles using International Patent Classification (IPC) codes.

Results

Our analyses illustrate patterns of product and process innovations in the biopharmaceutical industry and show how they differ from those of the chemical pharmaceutical industry.

Conclusions

Our study builds on the latest research on innovation theories to provide empirical evidence that demonstrates reshaping of innovation processes through utilization of scientific knowledge.

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Notes

  1. University of California, San Francisco, USA

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Author information

Authors and Affiliations

  1. Product Development Department, LG Life Science, 58, Saemunan-ro, Jongno-gu, Seoul, 110-061, South Korea

    Su Young Lim

  2. Graduate School of Technology & Innovation Management, Hanyang University, 222, Wangsimni-ro, Seongdong-gu, Seoul, 133-791, South Korea

    Su Young Lim & Minsuk Suh

Authors
  1. Su Young Lim
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  2. Minsuk Suh
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Corresponding author

Correspondence to Minsuk Suh.

Additional information

Summary: Compared to small-molecule drugs, biopharmaceuticals require significantly more complex processes for R&D and production. In this work, we tracked and categorized patented biopharmaceutical technologies along the innovation cycles timeline using International Patent Classification (IPC) codes to show that the biopharmaceutical R&D process has been evolving from the conventional pattern of innovation. Our study builds on the latest research on innovation theories to provide empirical evidence that demonstrates reshaping of innovation processes through utilization of scientific knowledge. Based on our results, we provide strategic perspectives on the biopharmaceutical industry.

Teaser: We tracked and categorized patented biopharmaceutical technologies along the innovation cycle timeline using IPC codes to show that the biopharmaceutical R&D process has been evolving from the conventional innovation pattern.

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Lim, S.Y., Suh, M. Product and Process Innovation in the Development Cycle of Biopharmaceuticals. J Pharm Innov 10, 156–165 (2015). https://doi.org/10.1007/s12247-015-9214-9

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  • DOI: https://doi.org/10.1007/s12247-015-9214-9

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