P46351 7th Annual Cell Line Development and Engineering Asia 2018
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7th Annual Cell Line Development and Engineering Asia 2018

15 – 17 May 2018, Hilton Shanghai Hongqiao Hotel, China

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overview

IBC’s 7th Annual Cell Line Development and Engineering Asia is part of Biopharma Development and Production (BDP) Week 2018. The industry’s foremost event showcases the views of top technical professionals in both research and industry best practices in engineering and optimizing cell lines for low cost, high quality, high productivity and scalability. Benchmark R&D, regulatory and commercial considerations between China and the rest of the world, and network across multiple events to make the most of your investment.

Key highlights

  • 300+ Companies, 70+ speakers, 60+ Sessions
  • Unparalleled learning and targeted networking across three 3 co-located events
  • Innovative approaches in early cell line development
  • Revolution of Gene-editing tools in Cell Line Engineering
  • Optimizing Technologies for Antibody therapy
  • Scale-up and Process Development
  • Assuring High Yield and High Quality
  • Preview latest equipment and technologies and hear from top vendors on how they are partnering with your peers
  • Innovation in technologies and manufacturing process

Part of

Biopharma Development & Production >>

Co-Located Events

Biosimilars Asia >>
Cell Line Development and Engineering >>
Biomanufacturing >>

agenda

9:00 am

Analysis is critical in the assurance of quality and compatibility of protein pharmaceuticals, such as biosimilars.  However, given the complexity of biotherapeutic products and the analytical processes, analytical artifacts abound. Moreover, many of these artifacts have been overlooked, even the process and results are reproducible.  In this workshop, common and crucial artifacts will be reviewed, their mechanisms be discussed and potential solutions be proposed.

What You will learn:
Understanding various artifacts, both false positives and false negatives, exist in the analysis of protein pharmaceuticals.

With specific focus on following areas:

  • A highlight on attributes in relation to chemical transformations, e.g., deamidation and oxidation, during sample preparation.
  • The labile nature of certain protein modifications, such as glycation and trisulfide.
  • Some are attributed to unknown or not pre-defined proteins modifications, such as crosslinking.
  • Artifact of analytical methods

8:00 am

Day 1 Main Conference Registration Opens and Morning Coffee

9:00 am

Chairperson’s Opening Remarks

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS

9:10 am

 

  • Innovation in biopharma pipelines – what developments can we expect?
  • Recent regulatory developments – obstacle or opportunity?
  • How digitalization of the BioPharma industry is creating new value propositions
  • Biomanufacturing market snapshot in China 
  • Biosimilars market potential – what can we achieve?
  • New trends in cell line development   

More panellists to be confirmed.

 

9:50 am

  • Investment outlook and market drivers for biopharma investments in Asia
  • Taking advantage of a variety of innovative R&D financing and partnership models
  • Assessing current investment climate and its implications on Chinese biotech market

10:20 am

Transforming BioPharma with Technology and Digitalisation

Wang Honglou, CIO, livzon Pharmaceutical Group

10:50 am

Morning Networking and Refreshment Break.

END OF OPENING PLENARY AND CELL LINE DEVELOPMENT & ENGINEERING ASIA COMMENCES

11:20 am

Chairperson’s Opening Remarks

Zhaohui Sunny Zhou, Professor, Department of Chemistry and Chemical Biology Faculty Fellow, Barnett Institute of Chemical and Biological Analysis Northeastern University, Boston, Massachusetts

CLONE SELECTION STRATEGIES, ESTABLISHING CLONALITY AND STABILITY

11:30 am

  • FDA concerns regarding single cell cloning procedures and assurance of monoclonality
  • Expectations for clonal cell lines
  • Identifying alternative methods and control strategies for establishment of clonality

12:00 pm

 

  • Novel technologies engineered to provide process control while at the same time enabling optimal leverage of the cell factory using ChemStress fingerprinting
  • Utility of CHO cell factories derives from exploitation of their acquired genetic/functional variation, which enable industry to identify cell lineages with desirable manufacturing properties
  • Analyzing cell clone stability profiles using the ChemStress Fingerprint and product-specific algorithms – shortening clone stability assessment timelines and reducing costs

 

12:30 pm

  • Managing cell-line instability and its impact during cell-line development
  • Strategies for faster and more efficient selection of suitable clones
  • Ensuring cell-line stability and clonal heterogeneity

1:00 pm

Networking Lunch and VIP Tables

ADVANCEMENTS IN CELL LINE DEVELOPMENT TECHNIQUES

2:00 pm

  • Overview of the current regulatory position on monoclonality
  • A new, verified, analytical approach to the estimation of the probability of monoclonality that greatly improves the quality of monoclonality reporting in regulatory submissions.
  • Case studies covering the positive impact on workflow and laboratory efficiency
  • Application to CAR-T and targeted gene editing methods such as ZFNs, TALENS and CRISPR/Cas9

2:30 pm

  • Regulatory landscape for cell-line development process
  • Analytical challenges and platforms for characterization of engineered host cell line
  • Determining performance characteristics of engineered cell lines

3:00 pm

Afternoon Networking & Refreshment Break

3:30 pm

  • CFDA expectations for cell-line development process
  • Analytical requirements for proper characterization & optimization of host cell line
  • Determining performance characteristics of qualified cell lines

QBD, PAT AND EARLY INTERVENTION STRATEGIES

4:00 pm

  • Changes in cell culture conditions affect more than just product yield & glycosylation steps
  • Working to reduce post-translational modifications, which could severely impact drug product quality
  • Happy cells for happy products: metabolite profiling as an indicator of cell line “happiness”

4:30 pm

  • N-Glycans play a critical role in the pharmacology of biotherapeutics
  • N-Glycan analysis has traditionally been a tedious and time-consuming process
  • Next-generation sample preparation and analytical methods shorten time to results from days to hours

5:00 pm

  • Development of a “design space” for integrating CQAs, risk assessment/management and control strategies
  • Identifying process parameters and interactions that adversely affect cell culture performance and product attributes early on, to prevent problems at late-stage cell culture
  • Ensuring consistency in delivery of a cell culture process for therapeutic mAbs

5:30 pm

  • Cell line development as a process
  • How to monitor/control the process
  • Early predictors of final outcomes

6:00 pm

Networking Cocktails

8:55 am

Day 2 Main Conference

9:00 am

Chairperson’s Opening Remarks

Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

EMERGING CELL CULTURE TECHNOLOGIES AND APPLICATIONS

9:10 am

  • Currently there are no systematic analyses of small molecule function or platform technologies that permit cell culture engineers to rationally harness their potential to control manufacturing performance in a cell line and/or product specific manner
  • Development of a medium to high-throughput platform that enables rapid quantitative assessment of small molecules additives as a tool to create bespoke media environments designed to engineer cell factory function for optimal manufacturing performance

9:40 am

  • Impact of host cell line on product glycosylation
  • Using CRISPR-Cas9 technology to knockout GLUL from HEK293 cells
  • Production of rhEPO using engineered HEK293

10:10 am

Morning Networking and Refreshment Break

10:40 am

  • Importance of structuring appropriate antibody studies that are selective, specific & reproducible
  • Generating genetically humanized mouse models for preclinical antibody efficacy studies
  • Strategies for generating good evaluation data and pitfalls to avoid

THERAPEUTIC MAB INNOVATION AND DISCOVERY

11:10 am

  • Strategies for faster and more efficient selection of suitable clones
  • Ensuring cell-line monoclonality
  • Ensuring cell-line stability and clonal heterogeneity

11:40 am

  • Highlighting the potential to lead to a novel therapy principle for the treatment of diabesity, NASH
  • Dual activation of the GLP-1R and GCGR
  • A novel GLP-1/GCG chimeric peptide/Fc fusion protein – developed and exhibit potent body reduced effect, improvements in multiple metabolic parameters in DIO mouse

12:10 pm

Networking Lunch

NEXT GENERATION CELL LINE ENGINEERING AND EXPRESSION SYSTEMS

1:10 pm

  • Development of alternative expression systems especially for mAb variants without in vivo counterparts, new conjugated formats, or artificial molecules
  • Alternative expression systems offer biopharmaceutical manufacturers the chance to establish a stronger intellectual property position and improve their processes
  • Collaborating to advance novel expression technologies
  • Further advances and demonstration of utility

Moderator:
Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

 

1:50 pm

  • Novel NGS-integrated approach to identify transcriptionally active site(s) and beyond
  • Constructing landing pad for site specific integration via CRISPR/Cas9-mediated genome editing
  • Design and execute a pooled CRISPR/Cas9 screen using a knowledge-based focused library

2:20 pm

2:40 pm

  • 3D cell culture systems as a new utility tool for cancer stem cell research
  • Revealing a more realistic drug response in 3D culture systems as opposed to conventional culture methods
  • Generating significantly realistic results earlier in epigenetic experiments for more effective translational research

3:10 pm

Afternoon Networking & Refreshment Break

BIOPHARMA DEVELOPMENT & PRODUCTION 2018 CLOSING PLENARY SESSIONS

3:40 pm

4:20 pm

Chairperson’s Summary and End of Main Conference Day Two

pricing

Packages Price
2 Day ConferenceUS $1895US $1695Early BirdEarly Bird
Group Rate (2 or more delegates)US $1495Early Bird
Group Rate (4 or more delegates)US $1295Early Bird
Extras Price
Pre Conference Workshop US $300
Packages Price
2 Day ConferenceUS $977US $827Early BirdEarly Bird
Group Rate (2 or more delegates)US $752Early Bird
Group Rate (4 or more delegates)US $676Early Bird
Extras Price
Pre Conference Workshop US $150

 

  • Multiple Bookings Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR group rate.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • All delegates from Singapore-based companies are required to pay an additional 7% GST (SINGAPORE EVENTS ONLY)

Sponsorship

Partnership and Profile Building Opportunities are Now Available!
Contact us today to find out how you can position your company as a market leader at this event, and to explore the range of branding and marketing opportunities available.

View Sponsors and Exhibitors profile >>

speakers

Zhaohui Sunny Zhou

Professor, Department of Chemistry and Chemical Biology Faculty Fellow, Barnett Institute of Chemical and Biological Analysis Northeastern University, Boston, Massachusetts

Su Chen

Vice President Chengdu Kanghong Biotechnology Co Ltd

Xu Wei

Vice President, Manufacturing , Innovent Biologics

Abrar Mir

Managing Partner, Quadria Capital Investment Management Pte Ltd, Singapore

Wang Honglou

CIO, livzon Pharmaceutical Group

Jerry Clifford

Chief Operating Officer, Valitacell, Ireland

Dong Huifang

Director of Cell Line Development, WuXi Biologics, China

George Hutchinson

Head of Global Distribution, Solentim

Dr Zhang Peiqing

Analytical Science and Technology Coordinator, Novartis

Dr Jun Liu

Vice President, TOT Biopharma

Dr. John Yan

Applications Scientist, ProZyme

Hung Fai Poon

Chief Scientific Officer, Zhejiang Hisun Pharmaceutical Co., Ltd, China

Eric Chang

Head of Cell Line Development, JHL Biotech, Taiwan

Sam Zhang

Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

Prof. David James

University of Sheffield

Ng Say Kong

Staff Scientist, Animal Cell Technology 2, Bioprocessing Technology Institute, A*STAR

Qingcong Lin

Vice-President, Shenogen Pharma Group, China

Debby Chang

Associate Director – Cell Line Engineering and Development, Shanghai Hengrui Pharmaceutical, China

Shaoqing Yang

Vice President, Zhejiang Doer Biologics Co.

Sai Ling Liu

Chief Scientific Officer, Surfer Biotech, China

Dr Jun Yuan

R& D Director, Hisun Pharmaceutical Co. Ltd, China

Wen Zaiqing

Vice President of CMC, Generon Corpoation (Shanghai) Limited, China

Bo Qi

M.Sc. Vice President Head of CMC General Manager, Generon Beijing

Alvin Luk

Senior Vice President and Chief Medical Officer - Global Clinical Operations and Affairs, Shanghai Henlius Biotech Co Ltd, China

when & where

15 - 17 May 2018

Hilton Shanghai Hongqiao
No. 1116 Hong Song East Rd, Shanghai, 201103, China
Tel: +86-21-3323 6666

contact

Still have a question?

Speaking Opportunities
Win Min
+65-6508 2873
Win.Min@ibcasia.com.sg

Sponsorship Opportunities
Yvonne Leong
+65 6508 2489

Yvonne.Leong@ibcasia.com.sg

Media & Association Partnership Opportunities
June Tan
+65 6508 2465
June.Tan@ibcasia.com.sg

sponsors

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