7/28 Workshop Agenda     7/29 Main Agenda     報名表

2010 蛋白藥物發展關鍵技術論壇
Key Technology Forum in Protein Drug Development, Taiwan, 2010
July 28^th~ July 29^th, 2010

國際生技製藥產業將以蛋白質藥物為研發主流，已然成為不可逆之勢。但蛋白質藥物，特別是抗體藥物的研發，其所面臨的技術及法規門檻，卻是業界邁向是一領域的最大挑戰。
        為協助國內業界積極迎向是一挑戰，並為台灣的生技製藥略盡綿薄，台灣生技產業促進協會特別在本(99)年7月28、29日兩日，假台大國際會議中心，舉辦「2010年蛋白藥物發展關鍵技術論壇」。會中將邀請國際間知名生技製藥公司負責抗體藥物研發各項關鍵技術之人員來台，向業界作產業關鍵報告，並與國內業界代表就抗體藥物之研發流程，及各重要環節，進行面對面之研討，期對國內已參與是一領域或即將參與相關研發之業者，提供第一手經驗及最新之產業資訊。
        這項為期兩日之議程中，將對「蛋白質藥物開發與生產」(Drug Development and Manufacture)、「前後端產程開發」(Upstream and Downstream Process Development)、「分析方法以及製劑」(Analytical Method and Formulation Development)、「製程開發」(Facility Construction)、「品保法規」(QA and Regulatory) 等議題進行研論，會議首日並安排有專題研究會(workshop)，業者可依需要擇項或全程參與。
        台灣生技產業促進協會感謝行政院食品藥物管理局、經濟部工業局、國家衛生研究院、工研院生技所、經濟部生技產業推動小組、財團法人生物技術中心，對本研討會之支持。
        邀集國際抗體藥物開發首廠商中首屈一指之專家，為國內業者提共最新之蛋白質藥物發展資訊，確屬創舉，機會極為難得。敬邀各界先進把握機會，蒞臨指導，無勝感荷。
        Created through a sponsorship from the Taiwan BioTech Association, this inaugural symposium aims to highlight key innovative strategies and solutions that might help development and manufacturing of protein drugs in Taiwan. Subject matter experts from international protein drug community will gather together to present in the hopes of helping pharmaceutical industry in Taiwan to develop protein drugs that will ultimately benefit the greater community.
        In the coming Forum, we will focus on 1. upstream process development, 2. downstream process development, 3. analytical and bioassay method development, 4. formulation development and manufacturing, 5. facility construction, and 6. quality assurance and regulatory issues.
       

Secretariat, Taiwan Biotech Association
台灣生技產業促進協會秘書處

Scientific Advisory Board
Chris Hwang, Ph.D., Sr. Director, Genzyme
David Chang, Ph.D., Sr. Director, Genentech (Tentative)
Dennis Huang Ph.D., Vice President, Allergan
Ping Yeh, Ph.D., Director, Biogen-Idec

Invited Speakers
Wolfgang Berthold, Chief Technology Officer and SVP Technical Development of Biogen Idec International GmbH located in Zug
Weichang Zhou, Senior Director, Genzyme
Mindy Wan, Director, MedImmune
Curtis Monnig, Senior Director, Allergan
Ana Menendez, Senior Director, Catalent Pharma Solutions
Ping Yeh, Director, Biogen Idec
Chris Hwang, Senior Director, Genzyme
Terry Milby, Director, Genentech
Antonio Carion,Senior Engineer, Jacobs Engineering

活動時間：2010年7月28日- 7月29日（星期三、星期四）
Date：July 28 and 29 (Wed/Thu), 2010

活動地點：台大國際會議中心（台北市中正區徐州路2號)
Venue：National Taiwan University International Conference Center, Taipei, Taiwan

指導單位：行政院衛生署、經濟部工業局

主辦單位：台灣生技產業促進協會
Sponsor：Taiwan BioTech Association

協辦單位：經濟部生物技術與醫藥工業發展推動小組、財團法人生物技術開發中心、財團法人國家衛生研究院、工業研究院、中華民國藥品行銷暨管理協會。
贊助單位：台灣東洋藥品工業股份有限公司  

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2010/7/28 Pre-Conference One Day Training Course (Workshop)

生物檢定法的發展與確效  已額滿
Bioassay Method Development and Validation

Instructor： Ana T. Menendez, Ph.D. Sr. Director, Catalent Pharma Solutions
Registration： 8:30 am - 9:00 am

09:00 – 12:00 Morning Session: Bio-testing (potency assay) Workshop
13:30 – 17:30 Afternoon Session: Bio-safety (immunogenicity) Workshop
(詳細議程資料)

2010/7/29 Main Agenda 主要活動議程 尚有名額

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2010/7/28 Pre-Conference One Day Training Course

已額滿

生物檢定法的發展與確效
Bioassay Method Development and Validation
By Ana T. Menendez, Ph.D.

Introduction     Instructor Bio     Course Agenda

Sharpen your skills and make your assays robust by learning:

• Rational approaches to bioassay selection and optimization
• Transition of bioassays from early to late stage product development
• Strategies to increase accuracy and repeatability
• Techniques to avoid common technical problems
• Guidelines for bioassay validation and regulatory documentation

Course Description

Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The appropriate use of non-analytical immunological techniques (i.e., ELISA) is also critical during the detection and characterization of unwanted systemic responses to biological drugs (i.e., immunogenicity). The complexity of the matrices, materials and procedures involved in these unique technologies, however, results in significantly increased variability as compared to analytical methods if not developed correctly.

This course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. During this course students will also hear case studies that will add relevance to the lecture materials and provide a launch point for class discussion.

Benefits of Attending:

• Learn the Differences between GMP and GLP
• Gain understanding of the criteria for the selection of the appropriate bioassays to meet the regulatory requirements for your biopharmaceutical products
• Acquire insight into optimization strategies to reproducibly align your bioassay results to technical specifications
• Training in protocol design to successfully support your bioassay projects in pre-clinical feasibility studies, clinical qualification and pre-commercial validation
• Learn how to avoid common artifacts inherent in non-analytical assays
• Interact with bioassay development professionals to network and share scientific ideas
• Receive a comprehensive course book that serves as future reference

Who Should Attend:

• Bioassay, bioanalytical and immunogenicity scientists
• QA staff, validation specialists and regulatory personnel
• Clinical staff, pharmacologists and toxicologists
• Project Managers & outsourcing personnel

Course Instructor Bio

Ana T. Menendez, Ph.D., is Senior Director of Biotechnology at Catalent Pharma Solutions. She implemented various laboratories to verify the functionality, purity and safety of biotechnology products. The GLP/GMP biotesting services at Catalent consist of cellular, molecular, viral and immunological technologies.
Dr. Menendez obtained her Ph.D. in Microbiology/Immunology from NY Medical College and joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and worked on the development of Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Course Agenda

Morning Session

Introduction

• GMP and GLP Overview
• Phase-specific Industry Expectations

GMP Potency Bioassay

   Development

• Method Selection and Types of Assay
• Feasibility and Optimization Parameters
• Using a Design of Experiments Approach
• Critical Standards and Controls
• Preparation and Characterization of GMP Cell Banks
• Avoiding Edge and Hook Effects
• Setting System Suitability Criteria
• Implementing USP 1034: Parallelism versus Similarity

   Potency Bioassay Validation

• Pre-Validation
• Improving Ruggedness by Controlling Variability
• Setting Realistic Specs for Validation
• Differences between Phase I/II and Phase III validation
• Case Studies
• Developing the Validation Protocol
• Sample Analysis Expectation

Afternoon Session

GLP Immunogenicity Testing

   The immune response and the nature of antibodies

• Innate versus adaptive immune response
• Self versus non-self

   Regulatory Overview Immunogenicity

• FDA and EMEA Guidelines
• Non-clinical and clinical effects of Immunogenicity
• Risk-based strategies

   Screening Assays

• Selecting the correct method: ELISA, RIA, SPR or ECL
• Cut-Point determination
• Selectivity/Interference/Specificity/Sensitivity

   Additional Methods for Positive Samples

• Antibody Quantification
• Confirmatory Assays
• Neutralization Methods
• Characterization: Isotype and Idiotype

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Tentative Abstract

How to provide suitable and timely supply for biotech drug clinical testing and approval? Vagaries of facility utilization and costs during this development

Wolfgang Berthold Ph.D.
CTO Biogen Idec International GmbH
CH-6300 Zug, Switzerland

For the manufacturing of biotech drug candidates suitable for application in humans a number of requirements have to be fulfilled. The production process has to be defined and locked to be fitted into a facility of adequate size. Such Facility needs to be set up and run conscientiously under cGMP rules and has to be able to house this process for the generation of API or Bulk Drug Substance. The process lock down needs to include a meaningful formulation and delivery format of the dosage form. Sensitive analytical tests have to be in place to assess the suitability of process and product during the process and in the final container for consistency of both purity and stability and finally for a proper Quality release.
All these methods have to be established before the first patient can obtain a test sample under controlled, safe conditions. The management of a efficient and reliable execution of these diverse and demanding capabilities and their performance in appropriately controlled facilities and labs is a great challenge in itself but also for the economy of maintaining all these capacities and skilled staff. This is impacted by 3 major independent variables: Medical/Biological choices, the Bioprocess itself and Regulatory requirements including cGMP.
I will illustrate approaches and decision trees for such development and some perspectives provided by the more recent potential combination of high titer and single use equipment.

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Tentative Abstract

Intensifying cell culture process technology for manufacturing of biopharmaceuticals

Weichang Zhou, Ph.D.
Sr. Director, Genzyme, BioEngineering, Genzyme Corporation
45 New York Avenue, Framingham, MA 01701, USA

Over the last two decades, mammalian cell culture process technology has been matured and steadily intensified to produce increasing quantities of therapeutic proteins and antibodies. Fed-batch and perfusion cultures have evolved as the platform technologies for commercial manufacturing at scales of as large as 25,000L for fed-batch cultures and 4,000L for perfusion cultures. In addition to increasing bioreactor sizes, cell culture processes have been intensified by improving specific productivity of cell lines, culture media, optimization of process parameters, and feeding or perfusion strategies. As a result, very high cell concentrations and productivities have been achieved. In particular, cultures of myeloma and CHO cells have been yielding volumetric productivities, which are indicators of manufacturing capacities, from less than 50 mg/L-day in the early 1990s to more than 500 mg/L-day now for production of monoclonal antibodies. It is not uncommon nowadays that a fed-batch cell culture batch with a duration of less than 2 weeks can deliver as many as hundreds of kilograms of proteins for purification. This presentation will discuss approaches and challenges related to cell culture process intensifications, and provide considerations necessary to achieve robust manufacturing.

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Tentative Abstract

From Clinical to Commercial: Opportunities and Challenges in Downstream Process

Mindy Wan, Ph.D.
Director, Manufacturing Sciences and Technology (MS&T), MedImmune, Frederick Manufacturing Center (FMC)

Biotechnology drugs comprise the fastest-growing sector in drug development, and they are expected to account for more than 50 percent of all new product approvals by 2015. However, it is a long journey to bring a biological molecule to market. Downstream process plays a critical role in this journey duo to the complexity of its unit operations and constantly facing the challenges from upstream and clinical trials. Some industry case studies will be presented to illustrate the downstream process focuses at early stage development for clinical material manufacturing, late stage development to assure the quality of the product for phase III clinical trials and to get ready for commercial launch, and at commercial stage continuous improvements to bring the robust process, cost savings and smooth tech transfer to different manufacturing sites throughout the product life cycle management.

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Tentative Abstract

The Role of State-of-the-Art Analytical Characterization in the Development of Protein Biopharmaceticals

Curtis Monnig Ph.D.
Sr. Director, Biopharmaceutical Analytical Development, Allergan
Irvine, California USA

The rapid and efficient development of new biopharmaceutical drugs requires timely information about the structure and behavior of drug candidates under often widely varying conditions associated with its manufacture and clinical use. Recent advances in the analytical sciences are providing opportunities to quickly obtain information that was previously considered difficult if not impossible to acquire. Several examples utilizing these new technologies will be presented to illustrate the role and significance of analytical characterization in early relative to late stage clinical material development. Particular emphasis will be placed on utilization of this information to accelerate process and formulation development activities.

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Tentative Abstract

Effective Method Transfer of Complex Bioassays

Ana T. Menendez, Ph.D.
Senior Director, Bioassays & Biosafety Testing
Catalent Pharma Solutions

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Tentative Abstract

Integrating formulation and drug product development for therapeutic proteins

Ping Yeh, Ph.D.
Director, Protein Pharmaceutical Development,
biogen idec
Pharmaceutical Operation and Technology

Biopharmaceutical proteins are exposed to variety of solution conditions, solid-liquid and liquid-gas interfaces during their manufacture and final storage condition. Understanding how processing conditions and the final drug product container closure system affect the quality and stability of formulated protein can improve the robustness of the formulation selection process. Case studies are presented that highlight the advantages of integrating formulation and process development, thereby helping to avoid problems that occur during the manufacture and final storage of the drug product.

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Tentative Abstract

From Process Development to Commercialization - Role of Technology Transfer and Life Cycle Management

Christopher Hwang, Ph.D.
Sr. Director, Technology Development, Genzyme Corporation,
New York Avenue, Framingham, MA 01701

Biotechnology industry has been very successful over the past three decades in coming up with innovative drugs to make significant positive impact in the lives of many patients. While accelerating time to market also provides both competitive and financial benefits to the company; it must be balanced with investment needed for the overall lifecycle for the drug development. Much has been emphasized on the need to develop robust processes and analytics to help ensure consistent and high yield production in manufacturing, less has been focused on technology transfer which is needed to realize and demonstrate to both sending and receiving units, as well as regulatory authorities, that the technology transferred can be operated as it is intended and can consistently and predictably manufacture high quality product for the patients and the market. By employing a discipline and systematic approach to technology transfer, it will minimize issues to be resolved during and post transfer, maximize the likelihood of “right first time” Process Validation, ensure full compliance while building confidence with regulatory authorities, and meet timeline and budget goals.
This presentation will provide an overview of the business process of technology transfer and keys for success. Specifically, details and key points to consider for process readiness and various stages of transfer (planning, execution, monitoring, and closure) will be discussed, as well as common pitfalls or challenges and approaches to address them. The focus will be on transfer from Development to Manufacturing and Manufacturing Site to Site transfers.

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Tentative Abstract

Typical Drug Development Challenges for a Global Development Program

Terry Milby
Director, Genentech

Abstract (TBA in June)

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Tentative Abstract

Single-Use Bioreactor Facility Design Considerations

Antonio Carion
Senior Engineer, Jacobs Engineering

Process improvements and new technologies allow new opportunities for the design of Clinical Manufacturing Facilities. High Titers, Alternative Expression Systems and Improved Pharmacology require that future Clinical Manufacturing Facilities be highly flexible. Flexibility is required in both the technologies that are supported by these new facilities and in the Construction and Delivery of these facilities. This presentation will review the advantages of single use systems vs. traditional systems, emerging opportunities for single use systems, and will share case studies where the use of single use technologies have been successfully implemented.

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