cutting-edge advances in target discovery, cell line ... · audrey jia, m.d., ph.d, former fda...

IBCLIFE SCIENCES

Produced by:

International Marketing Partner:

LifeSciences

Associate Sponsor:

16 - 19 May 2016Grand Hyatt Shanghai, China

A Part of

Cutting-Edge Advances in Target Discovery,Cell Line & Antibody Development !

Featuring Insights From: BRAND NEWTOPICS FOR 2016!

Co-located with:7TH ANNUAL 6TH ANNUAL

Audrey JiaFormer FDA BiologicalProduct CMC Reviewer,Division of MonoclonalAntibodies, Office ofBiotechnology Products,CDER, USFDA, USA

John FlygarePrincipal Scientist,Genentech, USA

Qi Wei WuVice President, Head ofBiologics,Haixi Pharmaceuticals,China

Weon-Kyoo YouPrincipal Research Scientist,Hanwha Chemical Bio R&D

Center, Korea

Quinn YaoDirector, Global TechnicalOperation,AstraZeneca

Biologicals, USA

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

5TH ANNUAL

DEVELOPMENT & ENGINEERING ASIA

Pre-Conference Workshop, 16 May 2016WORKSHOP A: 9:00am - 4:00pmAntibody Discovery Forum

Post-Conference Workshops, 19 May 2016WORKSHOP B: 9:00am - 12:00pmMaking a Better Bispecific or Multispecific Antibody

WORKSHOP C: 1:00pm - 4:00pmControlling CHO Cell Glycosylation for Cell LineDevelopment

SupportingAssociation:

Session Spotlight Sponsor:

www.celllineasia.com

New target discovery and development:ADC and Bi-Specific case studies fromglobal leadersProtein quality control, analytical testing& accelerated characterizationInternational regulatory guidelines forestablishing cell line clonalityHumanization of antibodiesAnalytical control strategies for biologicsdevelopmentOptimizing transfection efficiency forcell lines, ensuring biopharmaceuticalquality and productivityTransient vs Stable vs Intermediateexpression systemsNew cell line engineering platforms &expression systemsProduct quality optimization: CriticalQuality Attributes (CQA)implementation strategies

Media Partners:

Exhibitor:

5TH ANNUAL


CONFERENCE DAY ONE17 MAY 2016 TUESDAY

7:00 to Breakfast Meet & Greet8:30 John Rasko, Immediate Past Chair, Advisory

Committee on Biologicals, Therapeutic GoodsAdministration (TGA), Australia

8:00 Registration & Morning Coffee

8:50 Welcome Address from IBC Asia & Ice Breaker

9:00 Chairperson’s Opening Remarks

Biopharma Visionary Keynote Sessions

9:10 Global Biopharma Policy & Market Trends• Rapid growth in biopharma: Challenges and opportunities• Emerging trends in biopharmaceutical production• Where is biopharmaceutical manufacturing heading?

9:40 China’s Biopharma: Opportunities & Biggest Challenges• 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 CMOís

• Different technologies: getting all the information required fromthe vendors

Panelists:Claudia Lin, Vice President of Quality and Compliance,Innovent Biologics, ChinaJoe Zhou, CEO, Genor Biopharma & Vice President,Walvax Group, ChinaWenzhi Tian, Founder and President, ImmuneOncoBiopharma, ChinaBai Xianhong, President, Biotech Pharmaceutical Co., Ltd,China

10.30 Morning Networking & Refreshment Break

Clonality, Screening & Selection forCell Lines

11:30 Regulatory Considerations in Establishing Clonality forCell lines Expressing Therapeutic Monoclonal Antibodies• 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 selectionAudrey Jia, M.D., Ph.D, Former FDA biological product CMCReviewer, Division of Monoclonal Antibodies, Office ofBiotechnology Products, CDER, USFDA, USA

12:10 Cost-Effective High Throughput Screening to SelectClones & Reduce Timelines• 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

screeningSenior Representative, Lonza

12:50 Networking Lunch & VIP Tables__________________________________________________________________________

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 aboveguests during the networking lunch!

Accelerating Characterization Processfor Cell Lines

2:00 Characterization of an Effective CHO Cell Line GenerationProcess for Biopharmaceutical Production• 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 processQi Wei Wu, Vice President, Head of Biologics,Haixi Pharmaceuticals, China

Humanization of Antibodies

2:40 Challenges and Opportunities for Humanization ofAntibodies• Use of CDR grafts vs phage display systems• Tackling patent issues for biobetters, biosuperiors etcModerator:Jeffrey Su, Executive Vice President and Chief Operation Officer,Sorrento Therapeutics, USAPanelists:Hung Fai Poon, R&D Director, Cell Culture, Hisun Pharma(Hangzhou) Co Ltd., China

3:20 Afternoon Networking & Refreshment Break

Protein Quality Control, Analytical Testing& Characterization

4:00 Analytical Control Strategy for Biological ProductDevelopment and Commercialization• Critical Quality Attributes (CQA)• Platforms to optimize mAb production• Bringing product to quicker commercialization through effective

analytical control strategy implementationQuinn Yao, Director, Global Technical Operation,AstraZeneca Biologicals, USA

4:40 Assessment of Effector Function of Different AntibodyRelated Therapeutics Via Multiple Assay Platforms• Bioanalytics regarding different antibody therapeutics formats• Evaluating assay analytical methods for whole IgG and Bispecific

antibodies• Some assays related to emerging immunothereapyJingyi Xiang, Head of Bioanalytics, Eureka TherapeuticsInc., USA

Interactive Roundtable Discussions

5:20 • Moderator will kick-start the session with (10 min)opening/introduction of the topic/issue discussed and raiserelated concerns/challenges

• Participants will form a discussion to identify the top 3solutions/strategies to resolve the challenge/issues (30 mins)

• Moderator will in between digest and summarise the keyoutcomes and strategies taking into account feasibility of thesolution presented (5 min each Moderator)

__________________________________________________________________________

Roundtable 1: QbD Strategies in Cell Culture andBioprocess Development for BiopharmaceuticalsHung Fai Poon, R&D Director, Cell Culture, Hisun Pharma(Hangzhou) Co Ltd., China__________________________________________________________________________

Roundtable 2: Mammalian Vs Microbial Vs AlternativeCell LinesDoug Chen, Director of Process Development, ShanghaiBenemae Pharmaceutical Co., China__________________________________________________________________________

Roundtable 3: Improving Glycosylation and Getting theRight Glycosylation Patterns

6:00 Chairperson’s Summary & End of Conference Day One

7:00 Networking Dinner

PAN

EL D

ISCU

SSIO

N

PAN

EL D

ISCU

SSIO

N

BOOKSEPARATELY

BOOKSEPARATELY

KEYN

OTE

AD

DRE

SS

REGISTER TODAY! +65 6508 2401 [email protected] www.celllinesasia.com

REG

ULA

TORY

AD

DRE

SS

5TH ANNUAL


CONFERENCE DAY TWO18 MAY 2016 WEDNESDAY

8:00 Main Conference Registration Opens & Morning Coffee

9:00 Chairperson’s Opening Remarks

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

Hot New Targets, Biologic Drug Discoveryand Development

9:10 Development at Genentech: Novel Anitbody-Antibiotic

Conjugate

• Composition: Anti-S. aureus antibody conjugated to a highlyefficacious antibiotic

• Eliminating intracellular S. AureusJohn Flygare, Principal Scientist, Genentech, USA

9:50 Anti-PDL1 Antibody-Based Bifunctional

Antibody/Protein for Enhanced Antitumor Immunity

• Building better monoclonal antibody-based therapeutics• Developing a novel anti-PDL1 bi-functional proteinZhenping Zhu, Executive Vice President, Global Biologics R&D,Kadmon Pharmaceuticals, President & CEO, Kadmon China,China

10:30 Morning Networking & Refreshment Break

11.00 Optimizing Transfection Efficiency for Cell Lines to

Accelerate Biopharmaceutical Discovery to Development

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

qualityCheng Zhang, CSO, GMax Biopharm, China

11:40 Cell Line Development of CHO Cells to Produce a Novel

Bispecific Antibody

• Selection of a single clone (CHO-DG44) to produce a novelbispecific 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

New Cell line Engineering Platforms &Expression Systems

12:20 Overcoming the Challenges for Cell Line Development

for Difficult to Express Proteins

• Increasing expression efficiency and product quality for difficultto express proteins

• Cell line development strategies and protein expression platformsfor difficult to express mAbs

• Integrated cell line and process development platforms

KEYN

OTE

AD

DRE

SS

1:00 Networking Luncheon & VIP Lunch Tables__________________________________________________________________________

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 BiologicsR&D, Kadmon Pharmaceuticals, President & CEO,Kadmon China, China__________________________________________________________________________

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

2.30 Developing a Robust Cell Line Development Platform

for High Quality Biosimilar Development• 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 productJian Ni, CEO, The National Engineering Research Center

of Antibody Medicine (CMAB), China

3.10 Stable Cell Lines Vs Transient Cell Lines for Antibody

Development: Is There an Intermediate?• 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


Quality and Yield During Scale Up

4:20 Improving Quality, Productivity and Scalability of Cell

Lines: Can We Have Both Quality and Yield?• 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 Chairperson’s Summary & End Of Conference

PAN

EL D

ISCU

SSIO

N

NEW

DAT

A


“The conference is fantastic and I gained a lotfrom the talks. I would like to recommend myco-workers to attend”Zhejiang Teruisi Pharmaceuticals

5TH ANNUAL

DEVELOPMENT & ENGINEERING ASIA WORKSHOPSPre-Conference Workshop, 16 May 2016, Monday FOCUS DAY A: 9:00am - 4:00pm

Antibody Discovery Forum12:15 Networking Luncheon

1.30 Optimizing Linker-Payload Compatibility of ADCs• Challenges in target selection, the impact of linker chemistry,

target-independent toxicity and drug resistance• Improving potency & stability of Antibody Drug Conjugates• Overcoming the limitations of heterogeneous conjugationBruce Nian He Han, Chief Scientific Officer,NewBio Therapeutics, China


3.00 Novel Site-Specific Conjugation Tools for ADCs• Established ADC tools including monoclonal antibody formats,

linkers and payloads• Introducing site-specific tools for conjugation of antibody• Evaluating pharmacokinetics for the site specific conjugation

4:00 Chairperson’s Summary

8:00 Pre-Conference Registration Opens & Morning Coffee

9:00 Chairperson’s Opening RemarksMoana Tercel, Senior Research Fellow, Auckland Cancer SocietyResearch Centre, Faculty of Medical and Health Sciences,The University of Auckland, New Zealand

9:10 Development of Multiple Antibody-Drug Conjugates forTargeting Different Types of Antigens• Trends and overview in global ADC development• Where are the opportunities?• Novel linker drugs for use in ADCs• In-depth review of ADCs being developed to target various

antigensSheldon Cao, CEO, Zova Biotherapeutics Inc., China

10:10 Morning Networking & Refreshment Break

11.00 Improving Potency and Stability of ADCs• How to generate high loaded ADCs?• Factors for improved stability, manufacturing & widening

therapeutic window• Analyzing ADC performance- in vitro potency versus in vivo

efficacy, and safety considerationsMoana Tercel, Senior Research Fellow, Auckland Cancer SocietyResearch Centre, Faculty of Medical and Health Sciences,The University of Auckland, New Zealand

Post-Conference Workshop, 19 May 2016, Thursday WORKSHOP B: 9:00am - 12:00pm

Making a Better Bispecific or Multispecific AntibodyThis interactive workshop is aimed at all professionals with interestin exploring engineering and production of Bi-Specific antibodies.

By attending this half-day workshop, participants will shareexperience and gain insights into:

Challenges for making a better bispecific or multispecific antibodybispecific or multispecific antibody clinical studiesHow to improve the productivity of a bispecific antibody?(Focusing on case study)How to address the quality and activity of a bispecific antibody?(Focusing on case study)

ABOUT YOUR WORKSHOP LEADER:

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


Dr. Zhiwei Song obtained his Ph.D. degree in Biochemistry from the Universityof Michigan where he studied protein glycosylation under the supervision ofDr. Irwin J. Goldstein. His post-doc work was completed in the BiologyDepartment at MIT in Dr. Hermann Stellerís lab where he studied the geneticcontrol of apoptosis using Drosophila as a genetic model system. He thenworked in Dr. Daniel I.C. Wangís lab at MIT for one and a half years. In 2002, Dr.Song moved to Singapore. Now he is a Principal Scientist at the BioprocessingTechnology Institute (BTI) of A*STAR. His research has been focused on proteinglycosylation, production of recombinant antibodies using CHO cells andapoptotic cell death in cultured mammalian cells.

Post-Conference Workshop, 19 May 2016, Thursday WORKSHOP C: 1:00Pm - 4:00pm

Controlling CHO Cell Glycosylation for Cell Line DevelopmentThis interactive workshop is aimed at all professionals with interestin exploring glycosylation control, characterization and potentialapplications of CHO glycosylation mutants in biopharmaceuticalproducts.

By attending this half-day workshop, participants will shareexperience and gain insights into:

Impact of glycosylation on therapeutic efficacy of recombinantbiologics, including mAbsIsolation and generation of CHO cell glycosylation mutants withcytotoxic lectins and genome editing technologiesAnalytical methods for characterizing protein glycosylationPotential applications of CHO glycosylation mutants in biotech

ABOUT YOUR WORKSHOP LEADER:

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

Weon-Kyoo You received his PhD in Biochemistry at Yonsei University in 2004.He worked as a postdoctoral fellow at UC San Francisco, and as a researcherat Sanford-Burnham Prebys Medical Discovery Institute from 2004 to 2012. Hewas successfully performed several research projects to test efficacy of variousangiogenesis inhibitors, small molecule compounds as well as biologics, usingpreclinical cancer animal models. Some tested small molecules and antibodydrugs have been approved by the FDA as anti-cancer drugs. Currently, hefocused on developing a bispecific antibody as more efficient anti-angiogenesisdrugs at Hanwha Chemical, which is in front of Phase I study.


IBCLIFE SCIENCES

16 - 19 May 2016Grand Hyatt Shanghai, China

A Part of

Cutting-Edge Advances in Target Discovery,Cell Line & Antibody Development

5TH ANNUAL


IBC Asia’s 5th Annual Cell Line Development and Engineering conference, provides a platformfor industry leaders from pharma/biotech, research institutes and technology providers to discussthe challenges, trends and collaboration opportunities in conducting new target discovery andcell line development in Asia.

In 2016, Cell Line Development & Engineering Asia will highlight exciting developments in newtarget and therapeutic antibody discovery, cell line engineering, explore efficient best practicesin scaling up and product quality all under-one-roof!

Discover and Develop robust cell lines with maximum quality, productivity and efficiency forscalability in production. Glean effective cell line engineering techniques, and also gain the latestupdates in antibody development with bispecifics, ADCs, and boosting therapeutic efficiencies.

An Under-One-Roof Approach!

5TH ANNUAL

7TH ANNUAL

6TH ANNUAL

Who Will Attend:

Why You Should AttendNew focus on target discovery, antibody development andachieving optimum protein qualityLatest technologies to accelerate the cell line developmentprocessEnhance cell line development in the early stages withoptimizing your cell culture, enhancing productivity yet ensuringqualityHear case studies from global pharma leaders on newtherapeutic compounds and novel cell linesLearn best practices in antibody development – effectivescreening strategies for target discovery and developingantibodies with enhanced properties for therapeuticsNetwork with industry leaders from two other co-located eventsBiomanufacturing & Biosimilars

BY GEOGRAPHY■ China 50%

■ Japan, Korea, Hong Kong, Taiwan 15%

■ US 10%

■ Europe 10%

■ Southeast Asia 10%

■ Rest of the World 5%

INDUSTRY BREAKDOWN■ Pharmaceuticals/Biotech 55%

■ Research Institutes/Universities 15%

■ CMOs 5%

■ Technology Solution Providers 20%

■ CROs 5%

WHY YOU SHOULD SPONSOR:Position your company as a market leader at this event and our customized Sponsorship & Exhibitionpackage offers prime exposure to key decision-makers and exceptional branding. To explore the rangeof thought leadership, speaking, branding and marketing opportunities available, please contactYvonne Leong • Tel: +65-6508-2489 • Email: [email protected]

SPONSORSHIPOPPORTUNITIES

“This has been a great conference and I enjoyed

the conference a lot. The quality of the talks are

high and the discussions were very dynamic”WuXi apptec

The Biopharma Development & Production Week 2016 isthe leading industry platform for pharma, biotech, CMOs,CROs, research institutes, investors, technology and industrystakeholders to meet, network and discuss current industrytrends, establish business partnerships and be updated oninvestment opportunities in China and surrounding Asia.

“It’s a wonderful meeting and I obtained much

new knowledge and I recommend it next year”Shanghai Hengrui Pharmaceutical Co., Ltd

Raise awareness for your servicesavailable to Early Discovery andCell Line Development valuechain in Asia!

cutting-edge advances in target discovery, cell line ... · audrey jia, m.d., ph.d, former fda...

Documents