從藥物的製程開發到生產的角度來看”整合型連續製造技術”的優點技術說明會 (12/28)

December 17th, 2015 | Categories: 2015, 小組活動 | Tags:

從藥物的製程開發到生產的角度來看整合型連續製造技術的優點技術說明會

 

The Benefits of Integrated Continuous Manufacturing – From Development to Manufacturing

 

The pharmaceutical industry employs batch manufacturing, an outdated process that is time-intensive and expensive ($50 B/year is wasted in inefficient drug manufacturing processes). This methodology suffers from a series of “stop-and-start”steps, which includes the isolation and transportation of intermediates across different unit operations and facilities. Consequently, lead times are very long and plant footprints are large. Analytical tests are performed on every batch (Quality by Testing), a suboptimal method of ensuring quality. As a result, quality issues and drug shortages have affected patient care.

To change this paradigm, Novartis invested $65 M in a ten-year joint research endeavor at MIT in 2007, to develop novel continuous flow manufacturing technologies for small-molecule pharmaceuticals. The project was successful, and led to the first pilot plant able to produce finished drug tablets from raw chemical ingredients through a fully automated, integrated continuous process (i.e. Integrated Continuous Manufacturing, ICM). ICM represents the ultimate state of lean manufacturing for pharmaceuticals. Consequently, Novartis has initiated the technology transfer to its novel “Technikum” Plant in Basel, Switzerland, with the aim of achieving commercial implementation beyond 2017. Similarly, in 2012, the Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing founded CONTINUUS Pharmaceuticals with the purpose of applying the technologies derived from this partnership to the broader pharmaceutical industry.

CONTINUUS Pharmaceuticals is an early stage drug manufacturing company that will enable companies to produce better quality medicines at ~ 50% reduced costs and >90% reduced lead times (MIT pilot plant reduced a 200 day process to 2 days), utilizing ICM technology. More specifically, CONTINUUS applies new state-of-the-art small-scale process technologies that are integrated into a seamless manufacturing process. In this way, raw materials are continuously transformed into finished tablets without interruption (24hrs/day), using a single plant with a footprint of 1/10 compared to existing batch plants. Also, CONTINUUS improves product quality with precise in-line monitoring and automated control of the entire process (Quality by Design). This ensures that medicines are within quality specifications throughout production, enabling real-time release.

Furthermore, CONTINUUS Pharmaceuticals will be able to provide value to its clients across the whole supply chain. For example, because of the reduced scale-up and the 24hr/day operation, the process of screening and testing reactions and other processes during technical development will be accelerated (faster to market). Downstream, distributors will not have to carry large amounts of inventory to achieve high service levels, as ICM will allow for significantly decreased work-in-progress and finished goods inventory. These, and other organizational changes afforded by this new continuous manufacturing process, will allow clients to run their manufacturing operations more efficiently.

In addition to the integrated end-to-end product offering, CONTINUUS offers targeted solutions to challenges encountered in batch manufacturing. More specifically, CONTINUUS’s novel continuous unit operations encompass continuous chemistry, continuous separation and purification including crystallization, and continuous drug product formation and coating.

 

主辦單位:Development Center for Biotechnology (DCB) / CONTINUUS Pharmaceuticals

   期:2015年12月28日(星期一) 13:30-15:20

    點:經濟部生技醫藥產業發展推動小組會議室 (台北市南港區園區街三號17樓A室)

    用:免費

報名網址:http://crm.biopharm.org.tw/news/1041208/

會議聯絡人:胡慶龍組長02-26558133 ext.120

 

 

議程(主辦單位保留修改議程之權利)

時間/Time

主題/Title

主講者/Speaker

13:00~13:30 報到/Registration  
13:30~13:40 引言/Opening Remark 生技醫藥產業發展推動小組 胡慶龍 組長
13:40~14:30 The Benefits of Integrated Continuous Manufacturing – From Development to Manufacturing Bayan Takizawa, MD, MBACo-Founder & Chief Business OfficerCONTINUUS Pharmaceuticals, Inc.
14:30~15:20 Q&A

 

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