生物製劑先導工廠-製程空間生物安全防護要項之研究

Abstract

生技新藥產業是知識密集的產業，重視創新與發明，研發期程往往需達5-10年以上的時間，其間所需資本與遭遇風險較高，但成功後報酬率大，產品生命週期亦長。生技新藥產業發展模式不同於代工製造為主的產業，涉及知識研發、執行法規、支援設施及基礎環境等。生物科技產業發展逐漸重要的同時，將使得「生技產業類建築」成為一高度專業知識的建築領域，尤其生物科技發展對製程環境之空間配置亦產生極大影響，無論在法令規範、硬體設施、人員施作經驗或是相關資訊上，該類建築的規劃設計、空間配置、確效管理及查廠等均是值得國內建築業發展的領域；此新的衝擊，將可使台灣的產業實力從加工製造業向上提升到研發產業。 建造「生物製劑先導工廠」，必須符合國內外相關cGMP及生物安全第三等級實驗室相關法規規定，且須能通過確效及查廠。基於上述法令條款要求嚴謹及相關資料短缺，使成為本文研究探討之目的。 「生物製劑先導工廠」於新藥研發時，對產品品質要求嚴謹、製程過程的環境要求嚴格，製程空間需求皆須為無菌潔淨環境。國內對生技製程BSL3實驗空間的研究資料不足，案例亦過於稀少，使得國內建築規劃設計者對實驗室空間配置所需相關知識相當模糊，為因應下一波生物科技產業革命，對生技建築先導工廠空間規劃之研究更刻不容緩。本研究主要探討製程空間於規劃設計時的主要需求項目，並以不同實驗空間的製程流程，反映至空間動線，成為規劃設計時的優先考量項目，設計者可透過本研究建立之檢核要項掌握生物製劑製程空間明確需求，建立正確的設計程序，並提供設計者作為同類型建築空間設計之參考依據。

The biopharmaceutical industry is a knowledge-intensive industry that values innovation and invention. Although capital costs and risks are high during the research and development stage, which can last from five to ten years, successful products offer high returns and their life cycles are long. The development model for the biopharmaceutical industry differs from that of the contract manufacturing industry. It involves researching and developing new knowledge, adhering to laws and regulations, establishing support facilities, and creating the underlying environment. As the biotechnology industry becomes increasingly valuable, biotechnology construction has become a highly specialized subfield of construction. In particular, advancements in biotechnology substantially impacted the configuration of space in a manufacturing environment. Areas worthy of further advancement in Taiwan’s construction industry include planning and design, space configuration, validation management, and plant inspections associated with biotechnology construction; specifically, the results of developing these areas can contribute to relevant laws and regulations, equipment and facilities, personnel experience. The impact of this new industry can upgrade Taiwan’s contract manufacturing industry to one with research and development capabilities. The construction of a biologics pilot plant must comply with both the domestic and international Current Good Manufacturing Practice regulations and Safety Guidelines for Biosafety Level 3 Laboratory. A pilot plant must also be validated and properly inspected. The aforementioned laws and regulations involve stringent requirements but information about these laws and regulations is lacking. Therefore, the objective of the present study was to examine these laws and regulations. The development of a new drug at a biologics pilot plant involves rigorous requirements for product quality and the environment of biologics production; a production space must be a sterile cleanroom. In Taiwan, research data regarding biosafety level 3 laboratories are inadequate and examples of these laboratories are sparse, causing domestic architects and building planners to have limited knowledge about laboratory space configurations. To face the next wave of revolution in biotechnology industry, there is a pressing need for research into the space planning of biotechnology pilot plants. In this study, we identified the key requirements for planning and designing a production space and used production processes required in various laboratory spaces to identify the optimal flows within the space of the laboratory. These requirements can be regarded as the priority requirements for planning and design a laboratory space. By utilizing the key requirements identified by this study, designers can gain a thorough understanding of the requirements for an adequate biologics production space and establish an appropriate set of procedures for designing such spaces. The results of the study can serve as a reference for the design of similar spaces.