BioProcess International China Conference & Exhibition

Process Development and Manufacturing Strategies for Biotherapeutics throughout the Product Lifecycle

August 12-13, 2015 · Grand Hyatt Shanghai · Shanghai, China

아젠다

2015년 8월 12일(수)

7:30
등록 및 커피, 전시회 및 포스터 발표 관람

8:20
의장 인사
Chengbin Wu, Ph.D., Chief Scientific Officer, President of R&D, Shanghai CP Guojian Pharmaceutical Co. Ltd., China

기조 강연

8:30
Robert Friesen, Ph.D. 새로운 구조를 이용한 다특이성 생물제제의 우수한 활성
Therapeutic Biologics designed to bind to multiple targets drastically alter the landscape of drug development by achieving previously unattainable levels of affinity and specificity. Antibodies and alternative scaffolds that bind to respective antigens individually are being used to create novel architectures capable of manipulating complex biological systems and delivering novel activities that are found only when binding to two or more targets simultaneously. We also engineer properties such as solubility, pharmacokinetics, and Fc effector function that can be critical to the clinical efficacy of a protein therapeutic molecule. This talk will highlight recent examples of how novel architecture of multi-specific biologics can be used to design highly potent molecules with sometimes unexpected activities.
Robert Friesen, Ph.D., Vice President and Global Head of Biologics Research, Biotechnology Center of Excellence, Janssen R&D, LLC (Johnson & Johnson), USA

9:00
Rene Hoet, Ph.D. 리드 항체의 발견과 최적화에 대한 Bayer의 혁신 전략
This presentation will discuss some of the innovative strategies we are using for antibody lead discovery using in vitro display technologies, high-throughput IgG screening to select functional, biological active antibodies early in the discovery process, phenotypic cell selection and screening to expand the target space and optimization for activity, reducing immunogenicity and improving CMC properties of antibodies.
Rene Hoet, Ph.D., Vice President Global Biologics, Antibody Lead Discovery, Bayer Healthcare, Germany

9:30
휴식시간, 전시회 및 포스터 발표 관람

10:10
의장 발언
H. Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China

업스트림 공정 개발:세포주와 세포 배양
프로세스

10:15
푸코오스 및 갈락토오스 불포함 항체 치료제의 생산을 위한 CHO 글리코실화 돌연변이체
Removal of core fucose from IgG1 antibodies is able to increase its affinity for FcgRIII and enhance ADCC. The galactose content of the N-glycans from different antibody products can vary significantly which is a critical quality attribute to batch-to-batch consistency. To address these industry-specific needs, we have created CHO mutants for producing fucose-free and galactose-free antibodies.
Zhiwei Song, Ph.D., Principal Scientist, Expression Engineering, Bioprocessing Technology Institute, Singapore

10:45
세포 배양에서의 단백질의 번역후 변형
This presentation will discuss the mechanics of cell culture process development. It will also provide perspectives on evaluating post-translational modifications of proteins in cell culture and offer new strategies for doing so.
Yanrong Dong, M.D., Senior Scientist/Group Leader, Cell Biology, AlphaMab Co. Ltd., China

11:15
고품질 바이오시밀러 개발을 위한 견고한 플랫폼
Case Study
Bringing biosimilars market currently requires large investments of money and there are high regulatory hurdles to obtain interchangeability, which biosimilars will need to compete with their reference product on the basis of quality, manufacturing time and cost. This talk will explore how steps in the generation of mammalian cell lines were optimized to make a process more efficient and certain considerations that were taken to balance the titer and stability vs. quality. A case study of our current cost-effective approach that consistently yields clonal lines and upstream culture conditions that result in 2.0 g/L antibody production in 12-day will be presented.
Qiwei Wu, Ph.D., Vice President, Head of Biologics, Haixi Pharmaceutical Inc., China

11:45
기술 프레젠테이션 모집중

10:10
의장 발언
Junyan Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical R&D, Genentech, a member of the Roche Group, USA

분석 전략과 처방 전략

10:15
임상개발 단계에서 단백질 치료제용 어세이 개선
Case Study
Assay improvement (or change) is common in the CMC development of biological products, as developers gain a more comprehensive understanding of the product quality and assay performance along the process development from early clinical development to product launch. This presentation will discuss the potential causes triggering assay redevelopment and the considerations for the activities that would be needed to support an assay change at clinical development stage. A few case studies (e.g., HPLC assays) will be used to demonstrate the technical rationale in the assay design as to how technical issues with old assays can be resolved in the new ones. Due to the complexity of biological product development, the solution for each case of assay change has to be product-specific and phase-appropriate.
Weijun Li, Ph.D., Senior Staff Development Scientist, Analytical Development and Support, Global Biological Development, Bayer HealthCare LLC, USA

10:45
조기 단계에서 상업화 단계까지 ADC 처방 개발의 문제
Junyan Ji, Ph.D., Senior Scientist, Late Stage Pharmaceutical R&D, Genentech, a member of the Roche Group, USA

11:15
단백질 제제에서 발생하는 응집 원인, 검출, 제어
Proteins have highly ordered three-dimensional structure which is critical for its bioactivity. Environmental changes during involved in formulation process may lead to generation of aggregates. Protein aggregates present challenges not only to the manufacturer but also to the patients. The current presentation provides an insight into origin of protein aggregates and how to detect as well as control them during formulation processes using multiple advanced techniques.
Paresh N. Vadgama, Research Scientist, Biotech Division, Lupin Limited, India

11:45
기술 프레젠테이션 모집중

12:15
네트워킹 런치, 전시회 및 포스터 발표 관람

1:30
다변량분석을 이용한 스케일업 세포 배양 모델의 개발
Case Study
Since there are geometric differences between scales, bioreactors at manufacturing scale often vary from bench scale performance. Such differences are typically manifested in different cell growth, protein productivity, and/or protein quality. Here, we describe a case study in which a scale up cell culture process model is developed to mimic historical bench scale performance using multivariate analysis. We identify gaps between scales and process adjustments were then implemented at manufacturing scale. This resulted in a successful scaled-up cell culture process.
H. Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China

2:00
최신 연구에 관한 프레젠테이션 모집중

2:30
세포 배양과 업스트림 프로세스
Abstract not available at time of print.
Changlin Dou, Ph.D., Deputy General Manager, BoAn Biotechnology Company, A Subsidiary of Luye Pharma Group, China

3:00
기술 프레젠테이션 모집중

품질관리, 품질 보증, QbD

1:30
생물의약품 GMP 기반 품질관리 미코플라스마 검출을 위한 qPCR 어세이 개발
Mycoplasma detection is one of the most time consuming assays in biopharmaceutical GMP QC. It takes twenty eight days with four subcultures; it is very labor intensive and highly costly due to special media required. qPCR is fast, cost efficient, and highly specific. Assay development results with several biopharmaceutical products will be presented. Assay specificity, accuracy, limit of detection, robustness, ruggedness, and most importantly comparability with existing point-to-consider assay will be discussed.
Gene Zhang, Ph.D., Senior Specialist, Quality Control, Bayer HealthCare, USA

2:00
품질면의 문제:GMP, 품질보증, 운영에 관한 검사 준비, 문서작성, 훈련
In this presentation we review current quality issues experienced by companies in China, focusing on actual examples from FDA records. We explain how many of these issues can be dealt with through proper preparation of documentation and through training. Attendees will have an opportunity to participate in a training example that enhances the learning experience and strengthens retention.
Scott M. Wheelwright, Ph.D., Founder and Principal Consultant, Complya Asia Co., Ltd., China

2:30
분석법 개발과 검증을 위한 QbD 어프로치
This presentation discusses the essential concepts associated with method develop including method characterization, risk assessment, robustness, stability and control. Further the presentation demonstrates DOE study design approaches to efficiently meet ICHQ2 and USP 1033 requirements for Method Validation. Best practices and analytical approaches for Specificity, Linearity, Range, Repeatability, Accuracy, Intermediate Precision, Limit of Detection, Limit of Determination and Limit of Blank will be presented.
Thomas A. Little, Ph.D., President, Thomas A. Little Consulting, USA

3:00
기술 프레젠테이션 모집중

3:30
휴식시간, 전시회 및 포스터 발표 관람

중국 국가식품약품감독관리국(CFDA) 및 미국 식품의약국(FDA)과의 규제에 관한
교섭 방법:사례 연구와 현재까지 얻은 정보

4:15
미국에서 생물의약품 개발 각 단계의 CMC와 GMP에 관한 규제면의 관점
Abstract not available at time of print.
Duu-Gong Wu, Ph.D., Director/Senior Consultant, PPD Regulatory Consulting and Former Deputy Division Director, Division of New Drug Chemistry, US FDA/FDER, USA

4:45
바이오베터 개발과 생산에 관한 CMC 전략과 규제 문제
Case Study
While biosimilar development represents the first wave, biobetter development through scientific and technical innovations ensues as the next wave of biopharmaceutical development in China. For antibody therapeutics, biobetters are designed to improve safety, efficacy, product stability, and/or convenience of use through humanization, affinity optimization, modulation of Fc effector functions by protein or host engineering, and/or process and formulation changes. Unlike biosimilar development, the focus of biobetter development is not on product comparability, but on demonstration of the superiority of key product characteristics. In China, biobetters with new molecular entities are considered as innovative drug candidates. As such, CMC strategies and regulatory considerations are different from biosimilars. Shanghai JMT-Bio focuses on biobetter and innovative drug development, our approaches and challenges will be discussed with case studies.
Minmin Qin, Ph.D., Chief Technology Officer and Senior Vice President, Shanghai JMT-Bio Inc., China

5:15
중국에서 생물제제의 상업 생산용 일회용(Single-Use) 바이오리액터 도입을 위한 검증 전략
Case Study
The Presentation will focus on the regulatory challenges that biologics manufacturers in China are facing for adopting SUBs for commercial manufacturing. It will also provide possible strategies and approaches to overcome those challenges and obtain regulatory approvals in a timely fashion. As a case study, the strategies and approaches adopted and being executed by Henlius Biopharmaceuticals will be introduced.
Scott Liu, President and CEO, Shanghai Henlius Biotech, China

5:45
첫째날 종료

2015년 8월 13일(목)

7:45
등록 및 커피, 전시회 및 포스터 발표 관람

8:25
의장 인사
Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

중국의 혁신적인 항체와 생물제제 연구개발에 관한 포트폴리오의 최신 정보

8:30
암치료용 생물제제의 Discovery와 개발
Different modalities of biologics such as monoclonal antibodies, antibody-drug conjugates (ADC), immunotoxins and cytokine-mimics have been developed or approved for cancer treatment. This presentation will focus on the discovery and development of our proprietary antibodies targeting the immune checkpoint for unleashing anticancer immunity and a few novel ADCs. The preclinical data of these molecules will be discussed.
Weikang Tao, M.D., Ph.D., CEO, The R&D Center, Shanghai HengRui Medicine Co. Ltd., China

9:00
중국의 치료용 항체 개발:바이오시밀러와 혁신적인 생물제제
The success of CP GuoJian, a China-based antibody development company, has demonstrated the fast growth of biologics R&D in China over the past 10 years. China has its unique strength in discovery and clinical research, and the bioprocess and manufacturing industry has matured rapidly. Although the earlier antibody development focused mostly on biosimilars, many companies are moving towards developing second generation and novel biologics products. This talk will address innovative biologics development capabilities and pipeline strategies at CP Guojian, including our work with ADCs and other modalities.
Chengbin Wu, Ph.D., Chief Scientific Officer, President of R&D, Shanghai CP Guojian Pharmaceutical Co. Ltd., China

기조 강연

9:30
Sherry Guo, Ph.D. 제1상 시험에서 승인후까지의 분석 관리 시스템 전략
A risk-based phase-appropriate analytical control system strategy for biologics products will be discussed and illustrated by examples of control systems in clinical and BLA stages. Practical approaches and risk assessment system following ICH guidance Q8, Q9 and Q9 will also be shared.
Sherry Guo, Ph.D., Head, Global MMTech Analytical Chemistry and Life Cycle Management, Biologics QC Network (PTQBQ), F. Hoffmann-La Roche Ltd., USA

10:00
휴식시간, 전시회 및 포스터 발표 관람

다운스트림 공정 개발:회수와 정제

Chairperson: Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

10:30
포유류 및 미생물 유래 바이오테크놀러지 의약품용 정제 프로세스 개발
The presentation will address factors, similarity and differences to consider for successful recovery and purification process development for mammalian or microbial-based biotechnology therapeutics manufacturing during the clinical development to commercial phase. The focus will be on ensuring manufacturing continuum from Phase 1 to Phase 3 clinical to product commercialization.
Suketu Desai, Ph.D., Vice President, Biologics Development, Drug Substance and Drug Product, Allergan, Inc., USA

11:00
최신 연구에 관한 프레젠테이션 모집중

11:30
프로테인 A:비화
Protein A is not as simple as it has been considered. Chromatin heteroaggregates accumulate on the resin surface during loading; interfere with pore access, and depress binding capacity. IgG is conformationally modified by protein A at this stage. Elution conditions maintain the conformationally modified form of IgG, promote contaminant leaching, and promote associations that cause aggregate formation and loss of IgG. pH neutralization of eluted IgG dissociates it from leached chromatin and promotes formation of chromatin particles that create turbidity.
Richard Nian, Ph.D., Research Scientist, Downstream Processing Group, BioProcessing Technology Institute, Singapore

12:00
기술 프레젠테이션 모집중

바이오매뉴팩처링, 설비 대응능력,
GMP 준수

Chairperson: Wen Ryan, Ph.D., Vice President of Technical Operations, Livzon Mabpharma, Inc., China

10:30
항체약물결합체(ADC)의 GMP 기반 생산
MabPlex has established an ADC manufacturing facility that includes GMP production units for antibody expression, small molecule synthesis, ADC conjugation, and filling/finishing. We developed various processes and quality standards to ADC drug manufacturing in large scale and have already supported an IND filing with CFDA for an innovative ADC drug.
Qibin Liang, Chief Operation Officer, MabPlex International, China

11:00
기술적 업무의 질
The therapeutic values of biologics have been increasingly recognized by the Chinese healthcare community. With the advent of biosimilars, the economical values have become ever more compelling. To realize the full medical potential, there must be genuine appreciation for the risks and benefits of biologics in that the safety and efficacy of a drug go hand in hand with Quality of Technical Operations - including Process Development, Clinical Manufacturing, Commercial Manufacturing, etc. This presentation will discuss the integration of key operational elements to enhance Quality of Technical Operations with an emphasis on biosimilarity and comparability.
Wen Ryan, Ph.D., Vice President of Technical Operations, Livzon Mabpharma, Inc., China

11:30
프레젠테이션 타이틀 미정
Speaker TBA, GE Healthcare

12:00
기술 프레젠테이션 모집중

12:15
네트워킹 런치, 전시회 및 포스터 발표 관람

바이러스 안전성과 바이러스 제거

1:30
바이오리액터 바이러스 안전성에 관한 기술개발
Abstract not available at time of print.
Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Global Biologics Development, Bayer Healthcare Pharmaceuticals, USA

2:00
바로 사용할 수 있는 일회용(Single Use) 크로마토그래피 칼럼을 이용한 바이러스 제거 검증 기술
Risk management for viral clearance goes along with the process chain. For removal of adventitious viruses derived from host cell, raw materials, employees and HVAC systems, in DSP different clearance steps such low pH, nano-filtration and chromatography steps have to be validated by spiking different types of model viruses. Preferentially ready-to-process single use chromatography columns are used as consistent and standardized down scale models for the commercial process. All these clearance steps have to be considered in early process development.
Rolf G. Werner, Ph.D., Professor, Industrial Biotechnology, University of Tuebingen, Germany

2:30
모노클로널 항체 기반 치료제의 생산에 대한 다운스트림 공정과 바이러스 안전성에 관한 문제
Development and commercialization of mAb innovative and biosimilar therapeutics is becoming a clear trend in the pharmaceutical industry because of patent expiration and clinical safety/efficacy profile of these blockbuster molecules and their extremely huge market potential globally. Recent clinical validation and demonstration of immunotherapeutic molecules such as PD-1 and PD-L1 mAbs illustrated much longer patient survivals, indicating the excellent potential of these molecules in oncology at a low dose with a high potency. Downstream processing and viral safety are key considerations after the right clone is selected for mAb production. In this presentation, after a brief introduction of global trends of mAb therapeutics and basic requirements of clone selection for commercial usage, challenges of downstream process development for mAb production is discussed. Strategic approaches for viral clearance are presented while current VC practices of Chinese CFDA and US FDA requirement is compared.
Joe Zhou, Ph.D., CEO, Genor, Walvax Bio Group and Visiting Professor, Peking University, China

3:00
기술 프레젠테이션 모집중

바이오시밀러 개발:규제면의 경험과 리스크 기반 전략

1:30
바이오시밀러 연구와 개발
Abstract not available at time of print.
Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China

2:00
중국에서 바이오시밀러/바이오베터 항체 치료제의 개발 진행시 품질과 동등성/동질성에 관한 실무적 문제
Abstract not available at time of print.
Feng Li, Ph.D., Chief Executive Officer, Beijing Mab-Works, Inc., China

2:30
모노클로널 항체 기반 바이오시밀러에 관한 사례 연구
Case Study
Abstract not available at time of print.
Zheru Zhang, Ph.D., CEO, Shanghai JMT-bio Inc., China

3:00
기술 프레젠테이션 모집중

3:30
휴식시간, 포스터 발표 및 전시회 관람

4:00
리스크에 중점을 둔 바이오시밀러의 개발과 관리
Quality and safety of drugs is a crucial topic for both the public and pharmaceutical companies, especially when biologics and biosimilars become the mainstream of drug development. This presentation will review the quality and safety risks associated with biologics and analyze their reasons, risk monitoring strategies and control processes. A risk-targeted biosimilar development and management strategy is proposed.
Jinhai Shi, M.D., Ph.D., Vice President, Tianjin Joint Academy of Biomedicine (TJAB), China

패널 디스커션

4:30
중국과 아시아 각국에서 연구개발을 추진하기 위한 제휴 전략
  • Collaboration strategies along the R&D value chain
  • Collaboration models (risk sharing, co-development, options, etc.)
  • Innovation strategies to boost China as a global R&D center
  • The role of MNCs in developing China as a global R&D source
  • China as a leading global R&D center in 2025: Reality or fiction?
Moderator:
Yariv Hefez, Vice President Business Development, Portfolio Management, Strategy and Partnering Biosimilars Unit, Merck
Panelists:
Scott Liu, President and CEO, Shanghai Henlius Biotech, China
Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd., China

5:30
컨퍼런스 폐막

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.