9th Annual Biomanufacturing 2019
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9th Annual Biomanufacturing 2019

14 – 16 May 2019, China

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LOCAL CHINA COMPANIES RATES AVAILABLE. 中国企业可享有独家优惠价!
SPECIAL GROUP RATES FOR 2 OR MORE. 2名及以上代表注册立享团队优惠价。SEE PRICING BELOW.

overview

Part of the Biopharma Development & Production Week (BDP), IBC’s 8th Annual Biomanufacturing Conference provides a timely platform for industry experts to have in-depth discussions on new biomanufacturing technologies, latest regulations, and ways to improve the speed, cost, quality of your process development and manufacturing efforts. Gain insights from top CMOs and Pharma on their challenges, learnings and strategies to improve competitiveness in this evolving industry.

2018 Attendees List

View list >>

Highlights

  • 300+ Companies, 70+ speakers, 60+ Sessions
  • Unparalleled learning and targeted networking across three (3) co-located events
  • Discover application of new disruptive technologies and how they are improving process development
  • Explore trends in facilities of the future and how to implement them
  • Challenges and opportunities in the increasing use of single use technologies
  • Learn from real world case studies on achieving operational, quality and cost effectiveness
  • CMO Selection and Oversight strategies
  • Preview latest equipment and technologies and hear from top vendors on how they are partnering with your peers

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Part of

Biopharma Development & Production >>

Co-Located Events

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

agenda

8:00 am

Registration Opens and Morning Coffee

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS 2018生物制药研发制造大会开幕全体会议

9:00 am

Chairperson’s Opening Remarks

10:10 am

[Industry Address] Global M&A Trends and Deal Flow in the Outsourced Pharma Manufacturing Services Sector

Andrew Huntley, Senior Managing Director, BDA Partners, UK

10:50 am

Morning Networking and Refreshment Break

END OF OPENING PLENARY AND BIOMANUFACTURING CONFERENCE COMMENCES

11:20 am

Chairperson’s Opening Remarks

Xu Wei, Vice President, Manufacturing, Innovent Biologics, China

THE MARKETING AUTHORIZATION HOLDER (MAH) REGIME 药品上市许可人制度

11:25 am

  • General requirements for manufacturing of biotech products: current FDA guidances
  • What should be submitted in BLA for US FDA for biotech products including biosimilar products
  • FDA Pre-license inspection coverages: three objectives

12:30 pm

Networking Lunch

UTILITY EFFICENCY AND OPTIMIZATION 设施有效性及优化

1:30 pm

  • It is crucial to ensure that a process developed is transferable anywhere
  • Process template transfer from Bordeaux to Shanghai
  • From the lab design to the first process comparisons
  • Use of single use technologies was key in this achievement

2:00 pm

  • The needs to optimize bioproduction and improve facility utilization
  • Modular continuous processing skids
  • Smart automation enable integrated continuous processing

2:30 pm

Case Study: Building a World-Class Highly Flexible Continuous Manufacturing Facility and Quality System in China

Dr. Frank Ye, SVP of Manufacturing and Quality, Hangzhou Just Biotherapeutics Co., Ltd., China

3:00 pm

Afternoon Teabreak

3:30 pm

Case study: Scale-up of Continuous Capture Chromatography

Johnson David M, Senior Global Product Manager, Continuous Purification, Pall Life Sciences, U.K.

4:00 pm

Innovation in Chromatograpy Platform: Lattice Supported Modular Chromatography using Conventional Resin Enabling Flexible Operations, Linear Scalability & Hyper-Productive Processes

Masayoshi Nagaya, Sr. Global Technology Manager, JSR Life Sciences

4:30 pm

Current Challenges of Biologics Manufacturing in China 中国生物制剂制造面临的挑战

Xu Wei, Vice President, Manufacturing, Innovent Biologics, China

5:00 pm

Efficacy of Insulation Systems in Aseptic Areas and Facilities: A Practical Guide to Facility Cost Reduction

David Sadler, President & CEO, Kunshan Zotek Kinglai Co. Ltd. U.K.

5:30 pm

From Process Development to cGMP Manufacturing - Process Control Strategy

Zack Zheng, Ph.D. VP of Process Development (Wuhan), JHL BioTech, China

5:55 pm

Chairperson’s Summary and End of Main Conference Day One followed by Networking Cocktail

8:50 am

Chairperson’s Opening Remarks

Yun Kang, Vice President of Manufacturing, Generon Beijing, China

INNOVATIONS IN MANUFACTURING SCIENCE TECHNOLOGY 制造科技的创新

9:00 am

  • Racing to clinical trials is crucial for startup biotech survival.
  • CMC development is one of the most critical IND enabling deliverables.
  • Leverage phase- and region- appropriate strategies is the key to expedite CMC development and IND filings

9:20 am

Rapid Microbiological Methods: Current Endotoxin/Sterility/Bacterial ID Applications in Bio Pharmaceutical Operations

John Dubczak, Director of Operations, Charles River Laboratories, U.S.

9:50 am

Multi-column, Parallelized Unit Operations Using a Single-skid for Intensified DSP at Pilot Scale

Nicolas-Julian Hilbold, DSP Innovation Specialist, Merck KGaA (sponsored by Novasep)

10:20 am

New Challenge by Samsung BioLogics in Biopharmaceutical Development and Manufacturing

Eun Young Yang, Executive Director, Head of CDO Business Development Team, Samsung BioLogics

10:40 am

Morning Tea Break

10:50 am

COLD CHAIN MANAGEMENT 冷链管理

11:10 am

Designing and Developing a Quality Driven Process to Mitigate Risk in Delivering Temperature Sensitive Biopharmaceuticals to Market

Iris Desiree Sioson, Reliability Manager, APAC, Envirotainer, Singapore

QUALITY COMPLIANCE AND SYSTEMS 质量合规和系统

11:40 am

Strategic Practice in Building Quality Management Systems (QMS) in China Facilities

Dr. Dennis Yu Xia, Vice President of Manufacturing and Quality, Akeso Bio, China

12:10 pm

Networking Lunch

1:10 pm

The Practice and Challenge of MAH Pilot Program under Current CFDA Regulation

Dr. Jiali Luo, General Manager of Boehringer Ingelheim Biopharmaceuticals China

FACILITIES AS COMPETITIVE ADVANTAGE

2:30 pm

  • Biopharmaceuticals booming in marketplace
  • Biomanufacturing facilities sprouting in China
  • Facility design/operation challenging to meet both CFDA and FDA/EMA requirements
  • Examples to illustrate cultural difference as reason

3:10 pm

  • Risk based microbial control strategy
  • Identification and implementation of measures to control the sources of microorganisms and the conditions that promote their survival and persistence
  • Monitoring of the facility, equipment, personnel, process, product and their interactions
  • Intervening or remediating when there is a drift from established controls

3:40 pm

Afternoon Networking and Refreshment Break

BIOPHARMA DEVELOPMENT & PRODUCTION 2018 CLOSING PLENARY SESSIONS

5:00 pm

Chairperson’s Summary of the Day and End of Conference

9:00 am

Pall has built the capability to offer End 2 End solution for monoclonal antibody manufacturing, both in batch processing and in continuous processing. This workshop will help you to update the newest strategy to build a pilot or commercial facility for Mab manufacturing.

 

4:00 pm

End of workshop

pricing

Packages Price
2 Day Conference - International Companies, Global HQ Located Outside ChinaUS $1895US $1695Early BirdEarly Bird
2 Day Conference - Local China CompaniesUS $977US $827Early BirdEarly Bird
Group of 2 or more delegates - Local China CompaniesUS $752Early Bird
Group of 2 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1495Early Bird
Group of 4 or more delegates - Local China CompaniesUS $676Early Bird
Group of 4 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1295Early Bird
Extras Price
Pre Conference Workshop - International Companies, Global HQ Located Outside China US $300
Pre Conference Workshop - Local China Companies 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 >>

VIP Programme

Become a VIP!
IBC Asia’s VIP Programme is an invitation only based network of the absolute top decision makers across specific industries. Our VIPs get an exclusively designed and tailored programme that enables them to network, indulge and enjoy, whilst experiencing a premium service for the duration of this event.

Dedicated to helping you find the most effective way of engaging with professionals and industry solution providers at our event, and scheduled alongside the main event line-up, it gives you an opportunity to glean benefits from the conference as well, and ensures that you get the most of your time on site with us.

Benefits of becoming a VIP:

  • 1-2-1 Meeting Service (Pre-scheduling meetings with your peers, speakers and other participants you may want to meet)
  • Closed Door Think Tank (An invitation-only forum headlined by an exclusive keynote address)
  • The VIP Lounge
  • Opening Ceremony (Access priority seats and be the first to engage with key speakers and other top decision makers)
  • Your Interview, Promoted Exclusively

A personalized VIP agenda will be sent to you via email upon receiving the confirmation of your registration.

To find out more, please contact:
Angeline Tan, VIP Relations Manager
Email: Angeline.Tan.SG1@ibcasia.com.sg
Phone: +65 6508 2874

Download VIP Programme brochure »

speakers

Dr. Ming Wang

President and Chief Executive Officer, Phanes Biopharmaceuticals, China

Xiao Zhi Hua

Chief Executive Officer, OPM Biosciences, China

Xu Wei

Vice President, Manufacturing, Innovent Biologics, China

Jerry Yang

SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd., China

Dr Jun Liu

Vice President, TOT Biopharma, China

Yanshan Huang

Chief Executive Officer, DOER Biologics, China

Andrew Huntley

Senior Managing Director, BDA Partners, UK

Zhihao (Peter) Qiu

Branch Chief, Division of Inspectional Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality, CDER, FDA, U.S.

Zack Zheng

Ph.D. VP of Process Development (Wuhan), JHL BioTech, China

Aurore Lahille

Head of EMEA E2E Process Development, Merck, France

Swee Nguan Lim

Director of Asia Pacific Sales, Finesse, part of Thermo Fisher Scientific, Singapore

Dr. Frank Ye

SVP of Manufacturing and Quality, Hangzhou Just Biotherapeutics Co., Ltd., China

Johnson David M

Senior Global Product Manager, Continuous Purification, Pall Life Sciences, U.K.

Masayoshi Nagaya

Sr. Global Technology Manager, JSR Life Sciences

David Sadler

President & CEO, Kunshan Zotek Kinglai Co. Ltd. U.K.

Yun Kang

Vice President of Manufacturing, Generon Beijing, China

John Dubczak

Director of Operations, Charles River Laboratories, U.S.

Nicolas-Julian Hilbold

DSP Innovation Specialist, Merck KGaA (sponsored by Novasep)

Eun Young Yang

Executive Director, Head of CDO Business Development Team, Samsung BioLogics

Iris Desiree Sioson

Reliability Manager, APAC, Envirotainer, Singapore

Dr. Dennis Yu Xia

Vice President of Manufacturing and Quality, Akeso Bio, China

Dr. Jiali Luo

General Manager of Boehringer Ingelheim Biopharmaceuticals China

Dr. John Zeng

Executive Vice President, Bioprocess Development & Pilot Plant Manufacturing, Shanghai Zerun Biotech Co Ltd, China

Dr. Jinyou Zhang

Senior Vice President/Head, Bio Development and Manufacturing, BeiGene Co. Ltd., China

Hui Cai

Head of QC Laboratory 2 & Head of Microbial Control Team, WuXi Biologics, China

Dr. Alvin Luk

Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., China

Zheru Zhang

President, I-Mab Biopharma, China

Shaoqing Yang

Vice President, Zhejiang Doer Biologics Co.

Noel Rob

Business Development Manager, Pall Life Sciences, UK

when & where

14 - 16 May 2019

contact

Still have a question?

Speaking Opportunities
Sophia Zhao
+65-6508 2491
 
sophia.zhao@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

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