製藥業連續製程可行性之外部環境評估

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阮健銘(Jian-Ming Ruan) 查詢紙本館藏

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工業管理研究所在職專班

論文名稱

製藥業連續製程可行性之外部環境評估
(Assessing the Impacts of External Environments on the Feasibility of Continuous Manufacturing in the Pharmaceutical Industry)

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至系統瀏覽論文 (2029-7-31以後開放)

摘要(中)

因應疫後復甦及地緣政治導致的去全球化影響，生物科技快速發展。CDMO成為生物科技領域的關鍵環節，為製藥公司提供委外服務。2021年研究發現製藥業的碳排放量高於汽車產業55%，年碳足跡約1.97億噸二氧化碳當量。為了減少碳排放，製藥業採取節能製造流程、使用再生資源及減少化學品使用等方式。創新和改革使生技製藥公司在環保方面扮演積極角色，推動全球永續發展。
為提高產量和品質，製藥業逐漸轉為連續製程，簡化流程，減少異常，縮短週期，降低錯誤風險。連續製程在永續發展推動下成為主流趨勢，降低碳排放、減少廢棄物並提高能源效率。然而，技術轉換成本、人員訓練及品質控管挑戰使製程轉換困難。PESTEL模型可從政治、經濟、社會、技術、環境及法律六個層面探討這些影響，為長期策略制定提供方向。
本研究使用PESTEL模型評估疫情（COVID-19, 2019~2023）後復甦、人口老齡化及國際地緣政治變化對製藥業製程改善的影響。政治上，政府支持技術發展降低企業風險及成本；經濟上，去全球化促使強化供應鏈合作應對貿易戰及地緣政治風險；社會上，製藥業需符合社會責任及品牌形象期望；科技上，連續製程需更多資源，企業需提升創新能力、研發技術及生產效率；環境上，推動技術創新及承擔社會責任是未來趨勢；法律上，中美貿易戰及美國法案降低藥價影響企業成本及獲利，《生技醫藥產業發展條例》促進風險分散及多元化發展。綜合來看，製程變更為連續製程是一個合適選擇。

摘要(英)

In response to post-pandemic recovery, aging of population and the de-globalization effects caused by geopolitical factors, the biotechnology sector is rapidly developing. CDMOs have become a crucial component in biotechnology, providing outsourcing services for pharmaceutical companies. A 2021 study indicated that the pharmaceutical industry’s carbon emissions are 55% higher than those of the automotive industry, with an annual carbon footprint of approximately 197 million tons of CO2 equivalent. To reduce carbon emissions, the pharmaceutical industry is adopting energy-efficient manufacturing processes, using renewable resources, and reducing the use of chemicals. Innovations and reforms are enabling biotech pharmaceutical companies to play an active role in environmental protection, promoting global sustainable development.
To increase production and quality, the pharmaceutical industry is gradually transitioning to continuous manufacturing, which simplifies processes, reduces anomalies, shortens cycles, and lowers the risk of errors. Continuous manufacturing is becoming a mainstream trend, reducing carbon emissions, minimizing waste, and improving energy efficiency. However, the challenges of technological transition costs, personnel training, and quality control make process conversion difficult. The PESTEL model can be used to explore these impacts from six aspects: Political, Economic, Social, Technological, Environmental, and Legal, providing direction for long-term strategy formulation.
This study uses the PESTEL model to evaluate the impact of post-pandemic recovery (COVID-19, 2019~2023) and geopolitical changes on process improvements in the pharmaceutical industry. Politically, government support for technological development reduces corporate risks and costs. Economically, de-globalization strengthens supply chain cooperation to cope with trade wars and geopolitical risks. Socially, the pharmaceutical industry needs to meet social responsibility and brand image expectations. Technologically, continuous manufacturing requires more resources, and companies need to enhance innovation capabilities, R&D technology, and production efficiency. Environmentally, promoting technological innovation and taking on social responsibility are future trends. Legally, the China-US trade war and US legislation to lower prescription drug prices impact corporate costs and profits. The "Act for the Development of Biotech and Pharmaceutical Industry" promotes risk diversification and diversified development. Overall, the shift to continuous manufacturing is a suitable choice. This study provides a clear analysis of the external environment, aiding future decision-making for companies.

關鍵字(中)

★ 外部環境
★ 連續製程
★ PESTEL模型
★ 製藥製程
★ 永續規劃

關鍵字(英)

★ External environment
★ Continuous manufacturing
★ PESTEL model
★ Pharmaceutical process
★ Sustainable planning

論文目次

摘要…………………………………....……………………………………………………....i
Abstract……………………………………………………………………………………....ii
致謝………....……………………………………………………………………………..iv
目錄……………………………………………………………………………………..…....v
圖目錄…...……………………………………………………………………………..…...vii
表目錄……...……………………………………………………………………………....viii
1第一章研究問題 1
1.1 製藥產業 1
1.2 研究動機 3
1.3 問題描述 8
2第二章文獻探討 10
2.1 製藥永續研究 10
2.2 製藥製程精進發展 11
2.3 製藥連續製程品管相關研究 12
2.4 PEST模型探討 13
3第三章研究方法 15
3.1問題分析 15
3.2 PESTEL模型 16
3.2.1 政治因素(Political) 16
3.2.2 經濟因素(Economic) 17
3.2.3 社會因素(Social) 19
3.2.4 科技因素(Technological) 20
3.2.5 環境因素(Environmental) 21
3.2.6 法律因素(Legal) 22
4第四章研究結果與分析 24
4.1 外部環境對製藥產業製程的影響 24
4.1.1 政治因素(Political) 24
4.1.2 經濟因素(Economic) 26
4.1.3 社會因素(Social) 28
4.1.4 科技因素(Technological) 30
4.1.5 環境因素(Environmental) 33
4.1.6 法律因素(Legal) 34
4.2 分析發現 37
5第五章結論與建議 39
5.1 研究結論 39
5.2 後續研究 40
6參考文獻 41

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指導教授

王啓泰(Chi-Tai Wang)

審核日期

2024-7-23

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