由於藥物研究開發的成本提高，由單一生技製藥公司完成藥品開發日漸困難，將產品線委外研究生產已然成為生技製藥產業的趨勢。目前全球前十大暢銷藥物之中，就有八項是生物藥品，生物藥品由於其結構複雜，在製程開發建立上更為困難，因此技術上的進步能夠大幅地降低藥物開發成本與減少藥品上市的時間。台灣在半導體接受委外生產已行之有年，但生物製造領域尚在起步階段，如何急起直追為一大挑戰，因此本論文就以製程技術為基礎，討論該領域廠商所掌握的技術，總結出全球的生產趨勢。
論文首先會在第二章說明委外生產的行業概況，並定義委外製造組織在整個生技製藥產業價值鏈中的位置，接著在第三章化學製造管制敘述製程建立的流程，並於第四章整理出目前全球的生產趨勢，最後在第五章介紹全球指標性的CMO廠商，第六章總結CMO行業趨勢並對台灣產業提出一些個人建議。
Due to the rising cost of drug research and development, it is becoming increasingly difficult for a single pharmaceutical company to complete the drug development. Outsourcing the pipeline has became a trend in biotech and pharmaceutical industry. At present, among the top 10 best-selling drugs in the world, eight are biopharmaceuticals. Because of the complex structure, biopharmaceuticals are more difficult to establish the chemistry, manufacturing and controls of process. As a result, technological advances can drastically reduce the cost of drug development and the time to market. Taiwan has been conducting outsourcing in the semiconductor industry for many years. However, the field of bio-manufacturing is still in the early stage. How to catch up the trends is one of the major challenges. Therefore, this paper based on the process technology, and discusses the technologies owned by manufacturers in this field and summarizes global production trends.
In the first chapter, this paper described the industry profile of contract manufacturing and define the position of contract manufacturing organization in the entire value chain of the biotech pharmaceutical industry. Then, in the third chapter, establishing the chemistry, manufacturing and controls of process is described. Chapter 4 listed the current global production trends and introduced several well-known CMOs in Chapter 5. Chapter 6 summarized the trends and make suggestions to Taiwanese manufacturers.
