PIC/S GMP廠房設計暨國際最新製程技術介紹與案例分享(11/13-14)

November 4th, 2014 | Categories: 2014, 其他廣宣 | Tags:

生物製劑製程之完整解决方案

PIC/S GMP廠房設計暨國際最新製程技術介紹與案例分享

The total Solution of Biologics Manufacturing Process—PIC/S GMP Facility Design, Innovative Bioprocess Technologies and Case Study

 

        因應國內生技醫藥產業快速發展之需求,此課程針對國際目前生技製程發展的最新技術與法規作完整的介紹。由`生技醫藥產業趨勢分析'導入,橫跨`PIC/S GMP生技藥品廠房設計/法規/建置/驗收',結合`microbioreactorDOE/MV軟體應用於上游製程最適化'到`下游製程新一代純化、病毒與黴漿菌(mycoplasma)去除之最新技術/法規'。

除此之外,有鑑於`單次使用技術'於國際上日益流行,會中亦針對此議題進行深入探討,同時以`風險評估之概念強化單次使用之袋子與濾心確效'上之重要性,並以`生技藥品之大規模冷凍/解凍技術'與`產品之無菌檢測技術與法規'作總結。

 

本次研討會除邀請來自Sartorius 德國原廠之專家擔任講員外,特邀請國內醣基生醫、健亞生技與丹麥NNE PharmaPlan專家主講相關議題,並於各訓練議題之間穿插相關設備之展示與實作,相信參與本次訓練課程的學員絕對能有滿滿的收穫。

 

主辦單位:財團法人生物技術開發中心DCB ( Development Center for Biotechnology)

協辦單位:台灣莎多利斯有限公司 (Sartonets Taiwan., Ltd)

日    期:1031113日(週四)1114日(週五)

時    間:9:00 – 17:00

地    點:台北市三重路19-11號E棟4樓443會議室(南港軟體園區一期南軟育成中心)

費    用:4,500元、10/31前完成報名匯款,享早鳥優惠價4,000元。(含講義及餐點)

報名方式(網路報名):http://www.dcb.org.tw/en_msg.aspx?a=2&i=949

匯款帳號:017兆豐銀行南台北分行 03009006136

抬頭:財團法人生物技術開發中心

 

聯絡窗口:

報名事宜生技中心鍾小姐02-26558133分機117  jrjong@dcb.org.tw

課程內容莎多利斯巫博士02-26988188分機205 jonathan.wu@sartorius-stedim.com.tw

講員資料請點此

※如有未盡事宜,煩請來電或是email,謝謝您!

 

議程(主要以英文演講)

  1. 第一天(11/13)

時間

講題

單位/主講人

8:40-9:00

報到

9:00-9:10

Opening Remark Development Center for Biotechnology \ Chien-Hsin Daniel Cheng

9:10-9:40

The Current Status of Biologic Drugs The senior Vice President of CHO Pharma\Jeff Wang

9:40-11:00

Design of Biotech facilities Head of the Vaccine Design group in NNE PharmaPlan\Klaus Hermansen

11:00-12:20

The integrated Solution for fully single-use/hybrid cGMP facility and process equipment design Senior PM of Sartorius Integrated Solution team\Michael Koch

12:20-14:00

Lunch and Demonstration

14:00-15:00

The use of factorial design on ambr platforms for rapid bioprocess development Bioprocess Product Specialist of Ambr system\Sunil Chhatre

15:00-15:15

Coffee break

15:15-16:15

Design of Experiment (DoE) and Multivariate Data Analysis (MVDA) as Fundamental Blocks of Process Understanding, Optimization, Predictive Monitoring and Control Senior Application Specialist at MKS Umetrics in DOE &MVA \David Wang

16:15-17:00

Demonstration

 

  1. 第二天(11/14)

時間

講題

單位/主講人

8:40-9:00

報到

9:00-10:00

Mycoplasma Retentive Filtration – Newly developed Membrane Filters Sartorius Global Product Manager Process Filtration\Braeutigam Ulrich

10:00-11:00

3rd Generation Virus and Contaminant Clearance Concepts- Peace of Mind with Triple-A Polishing Technologies Sartorius project manager of downstream process in Asia-Pacific \ Chen Yu

11:00-12:00

Wide application of single-Use technology in biopharma manufacturingprocess Head of Sartorius Fluid Management Technologies in Asia Pacific \ Nishant Soni

12:00-13:20

Lunch and Demonstration

13:20-14:20

Large Scale Cryopreservation of Biopharmaceutical Drug Product CEO of VLW Associates, Inc.\Vincent L. Wu

14:20-15:20

Pharmaceutical Sterility Testing Manager of Genovate Biotechnology Co, Ltd.\ Hou Ya-Wen

15:20-15:40

Coffee break

14:40-15:40

Risk Assessment Approach forFilter and Bag Validation Studies Sartorius Project Manager Validation Services Asia Pacific\Christian Boecking

15:40-

Demonstration

 

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