アジェンダ

1日目
 

2016年5月17日 (火)

7:00 to 8:30
規制機関の幹部を交えた朝食会
John Rasko, Immediate Past Chair, Advisory Committee on Biologicals, Therapeutic Goods Administration (TGA), Australia

8:00
メインカンファレンスの登録受付開始

8:50
IBC Asia代表による歓迎の挨拶

9:00
議長による開会の挨拶

生物医薬品業界のオピニオンリーダーによる基調セッション

(第6回Biosimilars Asia、第5回Biomanufacturingとの合同全体セッション)

9:10
基調講演:生物医薬品に関する世界各国の政策と市場のトレンド

  • Rapid growth in biopharma: Challenges and opportunities
  • Emerging trends in biopharmaceutical production
  • Where is biopharmaceutical manufacturing heading?

9:40
パネルディスカッション:中国の生物医薬品市場:ビジネスチャンスと最大の課題

  • Funding and investment difficulties in China are apparent, what are the reasons?
  • CFDA outlook
  • Review and approval speed of CFDA
  • How cGMP guidelines have been implicated in real time operation, not during audition
  • What it takes to get approval in US/EU from China?
  • Manufacturing sciences
  • GMP compliant manufacturing facility in China
  • Operation excellence and improvement
  • Product quality: how quality is evaluated by manufacturers?
  • Choosing the right partner - suppliers and CMO's
  • Different technologies: getting all the information required from the vendors

Panelists:
Claudia Lin, Vice President of Quality and Compliance, Innovent Biologics, China
Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China
Wenzhi Tian, Founder and President, ImmuneOnco Biopharma, China
Bai Xianhong, President, Biotech Pharmaceutical Co., Ltd, China

10.30
午前の休憩

治療用モノクローナル抗体のクローン性、スクリーニング、選定

11:25
議長の冒頭発言

11:30
治療用モノクローナル抗体を発現する細胞株のクローン性確立に関する規制面の課題

  • What clonality means for cell line development
  • The importance of ensuring the clonality of cell lines during drug development
  • Current cell line development technologies and imaging tools and their use in clonal cell selection

Audrey Jia, M.D., Ph.D, Former FDA biological product CMC Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, USFDA, USA

12:10
クローンの選定と時間短縮を可能にするコスト効率の高いハイスループットスクリーニング

  • Focusing on MoA for antibody Critical Quality Attributes during the selection process
  • Increase screening population to increase chances of higher product quality
  • Ensuring higher efficiency and viability of transfections to ensure faster screening
  • Cost-effective technologies to increase product pool during screening

Senior Representative, Lonza

12:50
関連企業の幹部を交えた昼食会

VIP 1 Quinn Yao, Director, Global Technical Operation, AstraZeneca Biologicals, USA
VIP 2 Qi Wei Wu, Vice President, Head of Biologics, Haixi Pharmaceuticals, China
VIP 3 Bruce Nian He Han, Chief Scientific Officer, NewBio Therapeutics, China

Exchange business cards and have an informal chat with the above guests during the networking lunch!

細胞株のキャラクタリゼーションプロセスの迅速化

2:00
ケーススタディ:生物学的医薬品製造に対応する効果的なCHO細胞株生成プロセスのキャラクタリゼーション

  • Optimizing the expression vectors
  • Minimizing resources and time during the selection
  • Balancing titer and stability vs. speed
  • Addressing protein quality during the process
  • Finding a robust upstream development process

Qi Wei Wu, Vice President, Head of Biologics, Haixi Pharmaceuticals, China

抗体のヒト化

2:40
パネルディスカッション:抗体のヒト化にまつわる課題と可能性

  • Use of CDR grafts vs phage display systems
  • Tackling patent issues for biobetters, biosuperiors etc        

Moderator:
Jeffrey Su, Executive Vice President and Chief Operation Officer, Sorrento Therapeutics, USA

Panelists:
Hung Fai Poon, R&D Director, Cell Culture, Hisun Pharma (Hangzhou) Co Ltd., China

3:20
午後の休憩

タンパク質の品質管理、分析テスト、キャラクタリゼーション

4:00
ケーススタディ:生物学的製剤の開発と商業化に対応する分析制御戦略

  • Critical Quality Attributes (CQA)
  • Platforms to optimize mAb production
  • Bringing product to quicker commercialization through effective analytical control strategy implementation

Quinn Yao, Director, Global Technical Operation, AstraZeneca Biologicals, USA

4.40
複数のアッセイプラットフォームを利用した各種抗体関連療法のエフェクター機能の評価

  • Bioanalytics regarding different antibody therapeutics formats
  • Evaluating assay analytical methods for whole IgG and Bispecific antibodies
  • Some assays related to emerging immunothereapy

Jingyi Xiang, Head of Bioanalytics, Eureka Therapeutics Inc., USA

5:20
グループ討論

ラウンドテーブル 1
生物学的医薬品のための細胞培養とバイオプロセス開発でのQbD戦略
Hung Fai Poon, R&D Director, Cell Culture, Hisun Pharma (Hangzhou) Co Ltd., China

ラウンドテーブル 2
哺乳類細胞株、微生物細胞株、代替細胞株
Doug Chen, Director of Process Development, Shanghai Benemae Pharmaceutical Co., China

ラウンドテーブル 3
グリコシル化の改善と適切なグリコシル化パターンの獲得

6:00
議長の総括、1日目終了

7:00
夕食会

 

2日目
 

2016年5月18日 (水)

8:00
メインカンファレンスの登録受付開始

9:00
議長の冒頭発言

Zhiwei Song, Principal Scientist, Expression Engineering, Bioprocessing Technology Institute, A*STAR, Singapore

注目を集める新たな標的、創薬、開発

9:10
Genentechでの開発:抗体抗生物質抱合体

  • Composition: Anti-S. aureus antibody conjugated to a highly efficacious antibiotic
  • Eliminating intracellular S. Aureus

John Flygare, Lecturer, Stanford University, Principal Scientist, Genentech, USA

9:50
基調講演:抗腫瘍免疫を強化するAnti-PD-L1抗体ベースの二機能性抗体とタンパク質

  • Building better monoclonal antibody-based therapeutics
  • Developing a novel anti-PDL1 bi-functional protein

Zhenping Zhu, Executive Vice President, Global Biologics R&D, Kadmon Pharmaceuticals, President & CEO, Kadmon China, China

10:30
午前の休憩

11.00
細胞株のトランスフェクション効率最適化による生物医薬品の創薬から開発までの期間短縮

  • Lipid-based transfection versus electroporation
  • Methods to check out transfection efficiency
  • Transfection methods evolving
  • High throughput transfection processes: efficiency vs product quality

Cheng Zhang, CSO, GMax Biopharm, China

11:40
ケーススタディ:CHO細胞の細胞株開発による新規二重特異性抗体の産生

  • Selection of a single clone (CHO-DG44) to produce a novel bispecific antibody by limiting dilution
  • Selection criteria for research cell bank (RCB) candidate
  • Development of research cell bank
  • Moving forward to GMP-grade manufacturing of master cell bank (MCB)

Weon-Kyoo You, Principal Research Scientist, Hanwha Chemical Bio R&D Center, Korea

新たな細胞株のエンジニアリングプラットフォームと発現系

12:20
ケーススタディ:発現困難なタンパク質に対応する細胞株の開発にまつわる課題の克服

  • Increasing expression efficiency and product quality for difficult to express proteins
  • Cell line development strategies and protein expression platforms for difficult to express mAbs
  • Integrated cell line and process development platforms

1:00
関連企業の幹部を交えた昼食会

VIP 1 Cheng Zhang, CSO, GMax Biopharm, China
VIP 2 Weidong Jiang, CSO and Vice President, Henlix Biopharmaceuticals, USA
VIP 3 Zhenping Zhu, Executive Vice President, Global Biologics R&D, Kadmon Pharmaceuticals, President & CEO, Kadmon China, China

Bring your questions and visit the above guests during the networking lunch!

2.30  
高品質のバイオシミラー開発を可能にする堅牢な細胞株開発プラットフォームの開発

  • Key consideration for cell line/cell culture development: Similarity, Stability, Reproducibility and Productivity
  • Evaluating the glycan profile of the biosimilar product
  • Process of clone selection to match the required quality profiles for the product

3.10 
抗体開発のための安定的発現細胞株と過渡的発現細胞株:中間的な細胞株の可能性

  • Introducing fed-batch process at an early stage
  • Modular approaches using transient and stable mammalian production
  • How to bridge longer time (stable) vs insufficient product quantity (transient)?
  • How to ensure a larger product pool from transient transfection?
  • How do you maintain quality in the production of your cell line yet ensuring high yield?

Moderator:
Weidong Jiang, CSO and Vice President, Henlix Biopharmaceuticals, USA
Panelists:
Changlin Dou, Deputy General Manager, BoAn Biotechnology Company (A Subsidiary of Luye Group), China

3:50
午後の休憩

スケールアップ時の品質と収率

4:20
細胞株の品質、生産性、拡張性の改善:品質と収率の両立

  • How do you maintain quality in the production of your cell line yet ensuring High yield?
  • Balancing quality and yield during scale up processes
  • How does it change during scale-up process?
  • What kind of method/model to use to prevent change of protein quality

5:00
議長の総括

 

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

Produced bySupporting Association  

 

 
Associate SponsorSession Spotlight SponsorExhibitor 
 
Media Partners   

IBC
 
International Marketing Partner  
   
Choose your language
Traditional Chinese
Simplified Chinese
Korean
English

SPONSORS & Exhibitors

SPONSORS

Exhibitors

Related Events




Catalog

イベントカレンダー
医薬品関連の国際会議