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The landscape of biopharmaceutical manufacturing has evolved significantly since 1982, moving from scaling up processes to focusing on quality by design initiatives for ensuring product quality and consistency. A pivotal aspect of this evolution is the technology transfer (TT), a complex, multifaceted process integral to the rapid production and distribution of life-saving drugs. This manuscript presents a novel approach to overcoming one of the key challenges in TT: replicating manufacturing conditions across different sites. Our research group has developed a suitcase-sized portable flow microreactor (FMR), whose optimized design includes a feedback mechanism based on flow versus pressure or viscosity measurements. This innovation significantly simplifies the replication of manufacturing conditions, thereby reducing the duration and complexity of TT. We detail the successful application of this strategy in a case study where interleukin-6 refolding processes were transferred from a site in Japan to the United States using the portable FMR. This paper not only discusses the technological advancements of the portable FMR but also explores its implications for future technology transfers in the biopharmaceutical industry, emphasizing its potential to enhance efficiency and streamline operations in a sector where time and accuracy are paramount.
Nakahara et al. (Fri,) studied this question.
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