“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,> “Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,> Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.

1. Produced by:
International Marketing
Partner:
Gold Sponsor: Associate Sponsor: Exhibitors: Supporting Association:
Media Partners:
JX Nippon Oil & Energy
19 - 22 May 2015
Grand Hyatt Shanghai, China
Part of
www.biomanufacturing-asia.com
IBC
LIFE SCIENCES
Enhancing Scale-Up Capabilities in China
Expert Faculty Includes
Richard O’Keeffe
Executive Director,
International Quality – Japan-
Asia-Pacific (JAPAC) Regional
Quality Head,
Amgen, Singapore
Lars Dreesmann
Executive Director Upstream
Manufacturing&TechTransfer
H84 & PT&PE H84,
Boehringer Ingelheim
Pharma, Germany
Lei Sun
Vice President, Technology &
Manufacture,
AutekBio, China
Eric Morfin
Senior Director, Project
Management & Operational
Excellence,
Allergan Biologics, USA
Shou-Bai Chao
Senior Vice President, Bio
Ventures, Global Operations,
AstraZeneca, China
Michelle Yu Xia
Chairman, President
& CEO,
Akeso Biopharma, China
Cuihua (Chloe) Liu
Executive Vice President,
Quality & Regulatory Affairs,
Alphamab, China
Dmitry Samarsky
Executive Vice President,
Technology & Business
Development,
RiboBio, China
PRE-CONFERENCE WORKSHOP & SITE TOUR: 19 MAY 2015
Boehringer Ingelheim Biopharmaceuticals Move to China -
Operational Excellence & Experience in 30 years Commercial
Manufacturing
POST-CONFERENCE WORKSHOP: 22 MAY 2015
Best Corrective & Preventive Action (CAPA) & Root Cause
Analysis Practices for Biomanufacturing Excellence
What’s New for 2015?
Genor Biopharma’s New Antibody Facility in
China
Shanghai CP Guojian Pharmaceutical’s
Complex Biosimilars Development
RiboBio’s First Oligonucleotide cGMP Facility
in China
Jiangsu T-mab Biopharma’s Clinical Approval
& Production of TK006, a Denosumab
Biosimilar
Allergan’s Execution of New, Seismically Safe,
Medical Facilities
Shanghai Zerun Biotech’s Innovative Insect-
Cell Baculovirus System forVaccine Production
Gmax Biopharma’s Antibody Facility
Development
AstraZeneca’s EfficientTechnologyTransfer in
Asia Whilst Complying with cGMP
Amgen’s Insight on Supply Security & Quality
in a 21st Century Biotech
Boehringer Ingelheim’s New
Biopharmaceuticals Facility
– Shanghai, China
ExExclusivclusive Site Site Te TourourExclusive Site Tour
5TH ANNUAL
Life
Sciences

2. BIOBIO
5TH ANNUAL
CONFERENCE DAY ONE
20 May 2015 | Wednesday
08:00 Registration Opens & Morning Coffee
08:50 Welcome Address from IBC Asia & Speed Networking
09:00 Chairperson’s Opening Remarks
Abdullah Baaj, CEO, Boston Oncology, USA
Biopharma Visionary Keynote Sessions
09:05 Global Biopharma Outlook: Opportunities & Challenges
2015 & Beyond
• Macro-analysis of the current biopharma environment and market
drivers
• What are the constraints, opportunities and challenges?
• Innovation in the industry- who is taking the lead? Who are the
silent players?
• How is Big Pharma and Biologics Majors reacting to the Biosimilars
opportunity?
• Where are the Next Generation MaBs Biosimilars likely to come from?
• Is there money to be made from Biosimilars?
• Pros and cons of serving multiple growing markets
Moderator: Yariv Hefez, Vice President Business Development,
Portfolio Management, Strategy and Partnering, Biosimilars Unit,
Merck Serono, Switzerland
Panelists:
Abdullah Baaj, CEO, Boston Oncology, USA
Racho Jordanov, President & CEO, JHL Biotech, Taiwan
Richard O’Keeffe, Executive Director, International Quality –
Japan-Asia-Pacific (JAPAC) Regional Quality Head, Amgen,
Singapore
9.45 Cutting Edge Insights into China’s Growing Biotech Market
• Perspectives on China’s biotech policies, regulation and markets
• Can Chinese Biosmilar brands compete effectively against Indian
and Korean Biosimilars globally?
• Information on the local regulatory and Government policies
• Private vs publicly funded biopharma research and development
• Growth strategies and key for success in a highly competitive market
Moderator: Shou-Bai Chao, Senior Vice President, Bio Ventures,
Global Operations, AstraZeneca, China
Panelists:
Joe Zhou, CEO, Walvax Group, China
Li Shi, CEO, Shanghai Zerun Biotechnology, China
MichelleYu Xia, Chairman, President & CEO, Akeso Biopharma,
China
Scott Liu, President & CEO, Henlius Biopharmaceuticals, USA
10.25 China’s Evolving Biopharma Policies & Regulations
• Update on China’s Biosimilars guidelines and biologic regulations
• Biomanufacturing standards
• Testing, GMP Inspections and product quality
Senior Representative, China Food and Drug Administration
(CFDA), China
10.50 Morning Networking & Refreshment Break
Flexible Facilities & New
Biomanufacturing Technologies
11:30 Chairperson’s Opening Remarks
Lin Hong, AssociateDirector,RegulatoryAffairs,AsiaPacificRussia
CIS (APAC), Abbott, USA
11:40 Fast-Tracking an Efficient Upstream ProcessTransfer & Scale-
Up of Biopharmaceutical Processes
• Process transfer
• Large scale manufacturing
• Commercialization
• ‘Fast-to-market’/ ‘Smart-to-Launch’
Lars Dreesmann, Executive Director Upstream Manufacturing &
TechTransferH84&PT&PE H84, Boehringer Ingelheim Pharma,
Germany
GOVERNMENT
ADDRESS
KEYNOTEPANELCEOPANEL
12:10 Hybrid MAb Facilities: Combining Single Use Technology &
Stainless Steel for China MAb Facilities
• Typical hybrid MAb facility designs
• Flexibility of stainless steel
• Where can stainless steel best improve overall facility costs?
• Strategic use of single use technology
• Facility design, construction and validation strategies
Niels Guldager, Senior Technology Partner, NNE Pharmaplan,
Denmark
12:50 Networking Lunch & VIP Tables
VIP Table 1: Robin Tan, Head of Analytical Technologies,
Shanghai CP Guojian Pharmaceutical, China____________________________________________________________________________________________________
VIP Table 2: Shou-Bai Chao, SeniorVicePresident,BioVentures,
Global Operations, AstraZeneca, China____________________________________________________________________________________________________
VIP Table 3: Michelle Yu Xia, Chairman, President & CEO,
Akeso Biopharma, China____________________________________________________________________________________________________
Exchange business cards and have an informal chat with the above guests
during the networking lunch!
2:30 Roundtable Discussions
Each leader will facilitate the discussion for 45 minutes. Leaders will then
share key takeaways on the stage for 5 minutes each. Choose your table
now! Email Gladys.Landicho@ibcasia.com.sg
____________________________________________________________________________________________________
Roundtable 1: GMP Regulation
Lin Hong, AssociateDirector,RegulatoryAffairs,AsiaPacificRussia
CIS (APAC), Abbott, USA____________________________________________________________________________________________________
Roundtable 2: Quality by Design
Kevin Zen, Senior Manager, Biologics Development, Allergan,
USA____________________________________________________________________________________________________
Roundtable 3: R&D Investment & Development
Fei Jiang, Director, Business Development, 3SBio, China
3:30 Afternoon Networking & Refreshment Break
Commercialization & Scale-up Strategies
4:00 Manufacturing Complex Biosimilars
• Introducing Biosimilars in global markets
• Conducting rigorous upfront analysis to meet international standards
• Developing Biosimilars vs Follow on Biologics
• Divergence in biologics and biosimilars manufacturing
Hui Hu, Vice Director, CPGJ Research Institute, Shanghai CP
Guojian Pharmaceutical, China
4:40 Overcoming Challenges of Scale-Up: Moving Strains from
Bench to Large-Scale Fermentation & Product Recovery
• Scale-up strategies for solid state fermentation systems
• Overcoming production scale-up challenges
• Development of robust approaches for the design and construction
• Transfer of laboratory validated strains to commercial scale
Panelists:
Lei Sun, Vice President, Technology & Manufacture,
AutekBio, China
Weidong Jiang, Chief Scientific Officer & Senior Vice President,
Shanghai Henlius Biotech, China
Hung Fai Poon, R&D Director, Cell Culture,
Hisun Pharmaceutical, China
5:30 Chairperson’s Summary & End of Conference Day One
6.00 Networking Cocktail
VIP 1: Eric Morfin, Senior Director, Project Management and
Operational Excellence, Allergan Biologics, USA____________________________________________________________________________________________________
VIP 2: Lin Hong, Associate Director, Regulatory Affairs, Asia
Pacific Russia CIS (APAC), Abbott, USA____________________________________________________________________________________________________
VIP 3: Michael Grogan, Head of International Logistics &
Distribution, Technical Operations,
Shire Pharmaceuticals, Ireland____________________________________________________________________________________________________
Exchange business cards and visit the above guests during the
networking cocktail!
PANELDISCUSSION
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomanufacturing-asia.com

3. BIOBIO
5TH ANNUAL
CONFERENCE DAY TWO
21 May 2015 | Thursday
9:40 Disposable & Stainless Steel HybridTechnique Used for the
Implementation of a New Process
• Single-use technologies
• Flexible GMP manufacturing set-up
• Global manufacturing network
Johannes Salzbrunn, Head of GMP Downstream / Fill & Finish,
Boehringer Ingelheim Shanghai Pharmaceuticals, China
10:20 Morning Networking & Refreshment Break
Track A: Facilities Track B: Production
10:50 Defining Specific Critical Quality Attributes in Different R&D
Processes
• Purities vs. impurities
• Purification method
• Formulation and process development
Cuihua (Chloe) Liu, ExecutiveVicePresident,Quality&Regulatory
Affairs, Alphamab, China
11.30 Insect Cell-Baculovirus System for Innovative Vaccine
Production
• Benefits of insect cell-baculovirus system for vaccine production
• Commercial status of insect cell-baculovirus system
• Challenges and strategies for vaccine production
John Zeng, Executive Vice President, Product Development &
Clinical Manufacturing, Shanghai Zerun Biotech, China
12:10 Production, Quality Control & Clinical Approval Process of
TK006, A Denosumab Biosimilar
• Establishing a quality program for biosimilars
• Understanding documents and reports
• Clinical trial application process
Yan Shan Huang, Senior Vice President, Antibody Pharmaceutics,
Jiangsu T-mab Biopharma, China
New Projects Process & Quality
10:50 New Antibody Facility in China
• Addressing efficiency measures
• How to lower production cost
• Discussing technology platforms
• Future trends of Biomanufacturing
Jason Li, Senior Director, Downstream Processing,
Genor Biopharma, China
11:30 Building an Antibody Manufacturing Facility: Path of a Start-
Up Company
• Transition from research to development to Biomanufacturing
• Discussing difficulties vs. opportunities
~ Regulatory ~ Resources ~ Investment
• Examining the planning and implementation process
Cheng Zhang, Chief Scientific Technology Officer, Gmax
BioPharm, China
12:10 Manufacturing & Applications of Oligonucleotides for
Research, Diagnostics & Therapeutics in China
• Key trends and demands for oligonucleotides in China
• Principles of oligonucleotide synthesis and manufacturing
• Construction and utility of the first cGMP oligonucleotide CMO in
China
Dmitry Samarsky, ExecutiveVicePresident,Technology&Business
Development, RiboBio, China
9:00 Chairperson’s Opening Remarks
Lin Hong, AssociateDirector,RegulatoryAffairs,AsiaPacificRussia
CIS (APAC), Abbott, USA
Global Biotech Advances
9:10 Supply Security & Quality in a 21st Century Biotech
• General concepts of Supply Security in a global biotech
• Approaches for developing markets
• How to deal with the challenges of a high risk market
• What can the industry do to change the culture
Richard O'Keeffe, Executive Director, International Quality –
Japan-Asia-Pacific (JAPAC) Regional Quality Head, Amgen,
Singapore
12:50 Networking Luncheon & VIP Lunch Tables
VIP Table 1: Masih Sabet, Associate Director Quality Assurance, APAC Technology Operation, UCB, China_________________________________________________________________________________________________________________________________________________________________________________________________________________
VIP Table 2: Cuihua (Chloe) Liu, Executive Vice President, Quality & Regulatory Affairs, Alphamab, China_________________________________________________________________________________________________________________________________________________________________________________________________________________
VIP Table 3: Zhonghui Lian, Deputy Chief Engineer, Technical Service Department, Beijing Yizhuang Biomedical Park, China
Exchange business cards and have an informal chat with the above guests during the networking lunch!
Biomanufacturing Project Design & Planning 2:30 Successfully Applying Quality by Design (QbD) Concepts to
Develop a Robust Protein Therapeutic Formulation
• Design and execution processes
• Risk assessment
• Analytical method
• Acquisition of representative date and data analysis
Kevin Zen, Senior Manager, Biologics Development,
Allergan, USA
Technology Transfer & cGMP
Efficient Technology Transfer in Asia Whilst Complying
with cGMP
• Basic principles of GMP transfer of technology
• Defining GMP success and failure in a tech transfer project
• Best practices for technology transfer
~ Processing ~ Packaging ~ Cleaning
~ Analytical Methods ~ Documentation
Xiaoyong (Sam) Wu, OSD Technical Lead, Astrazeneca, China
3:50 Afternoon Networking & Refreshment Break
Biomanufacturing Supply Chain Efficiencies
4:20 Distributing Biologics in Multiple Growing Markets
Efficiently
• Tapping multiple growing markets at the same time
• Dealing with different national regulatory authorities
• Planning, manufacturing and distributing across multiple locations
Michael Grogan, Head of International Logistics & Distribution,
Technical Operations, Shire Pharmaceuticals, Ireland
5:00 Cold Chain Management from Manufacturing to
Distribution of Biologics
• Prioritising storage and distribution of biological drugs
• Achieving end to end cold chain visibility
• Choosing a qualified logistics company
• Discussing the transit process and temperature monitoring
Masih Sabet, Associate Director Quality Assurance, APAC
Technology Operation, UCB, China
2:30 Best Practices for Executing Seismically Safe Medical
Facilities
• Stakeholders’ management in the design phase. How to ensure a
common set of expectations?
• A critical path to construction and implementation
• Preventing potential implementation problems
• Key principles for stakeholders decision making success
Eric Morfin, SeniorDirector,ProjectManagementandOperational
Excellence, Allergan Biologics, USA
Biomanufacturing Finance & Investment
Financing&InvestinginBiomanufacturingFacilitiesinChina
• Getting the best deal from government -- incentives, tax holidays
and grants
• Financing a China bio-manufacturing facility – onshore or offshore
capital, debt or equity?
• China’s competitive advantages and constraints as a base for bio-
manufacturing production
Peter Fuhrman, Chairman & CEO, China First Capital, China
3:50 Afternoon Networking & Refreshment Break
4:20 Commercial Viability of Antibody Drug Investment &
Development
• Understanding commercial viability of antibody drugs
• Discussing stability, structure and efficacy
• Challenges in the development and manufacturing of antibody
drug
• Research and development
Green & Energy Efficient Biomanufacturing Facilities
5:00 Going Green in Biomanufacturing
• Discussing sustainable measures in Biomanufacturing
• Enabling an energy efficient and sustainable facility
• Green technology
• Green chemistry
5.40 Chairperson’s Summary & End of Conference
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomanufacturing-asia.com

4. BIOBIO
5TH ANNUAL
WORKSHOPS
Boehringer Ingelheim Biopharmaceuticals Move to China - Operational
Excellence & Experience in 30 years Commercial Manufacturing
PRE-CONFERENCE WORKSHOP: 19 MAY 2015 TUESDAY (9.00am - 4.00pm)
WORKSHOP A
Boehringer Ingelheim, one of the world’s largest manufacturers of biopharmaceuticals is building a biopharma manufacturing footprint for
high-quality and fast commercialization of products from mammalian cell culture for domestic and multinational companies in China.
Explore our biopharmaceutical development and manufacturing experience and learn from our experts in cell line development, process
science and manufacturing.
Exclusive Site Tour to Boehringer
Ingelheim’s New Biopharmaceuticals
Facility in Shanghai, China
(1.00pm - 4.00pm)
About Your Workshop Leader:
POST-CONFERENCE WORKSHOP: 22 MAY 2015 FRIDAY (9.00am - 4.00pm)
WORKSHOP B
Best Corrective & Preventive Action (CAPA) & Root Cause Analysis Practices
for Biomanufacturing Excellence
CAPA has been the #1 reason for 483 observations since 1997. The
FDA’s enforcement plan makes it clear: Developing a successful CAPA
program has never been more important. But creating an FDA-proof
CAPA isn't easy. Lack of Root Cause Analysis skills is the major contributor
to CAPA failures. If only drug and device makers could pick the brain
of someone who is coping successfully with CAPA, the best and the
brightest, an industry leader who has devised programs, procedures
and solutions that have put companies out in front with the FDA. Well
now you can by attending this workshop.
Key topics to be discussed include:
Gain valuable strategies for performing in-depth interviews and
determining individuals responsible for an event.
Discover best practices for training, assigning and managing your
lead investigators, using proven law enforcement techniques.
Benchmark current best practices in CAPA and investigations with
your peers.
Learn a systematic Root Cause Analysis process to be used in all
your CAPAs
Describe the Problem Phase
Teaches participants to confirm what kind of action is needed. When a
temporary fix is not appropriate and you need to select a permanent,
corrective action, you will need a logical step by step process to identify
root cause.This phase will help you describe the problem with factual data.
It will pinpoint what critical information might be missing as well as highlight
what information is irrelevant to the problem. This phase will allow for the
quick elimination of causes that have nothing to do with the problem.
Identify and Evaluate Possible Causes Phase
Participants learn how to identify the relevant changes. Things change
constantly, however, only certain changes are related to the problem.
Identify them will enable you to develop a small number of causes to test
against the factual information gathered in the previous phase. Causes are
developed and evaluated.
Confirm True Cause Phase
Participants learn how to confirm the root cause before making expensive
changes to the environment.The most likely cause is verified before moving
to the resolution stage. Proper documentation of the analysis as well as
the corrective action implemented is key to avoiding problems from
recurring.
About Your Workshop Leader:
Eric Morfin, Senior Director, Project Management and Operational Excellence, Allergan Biologics, USA
Eric Morfin is a partner with Critical Skills Inc. and the Clinical Excellence Research Institute and has over 27 years of leadership and managerial
experience in Life Sciences. Mr. Morfin has led many departments, such as Project Management, QA/QC, Data Management, Operations, Clinical
Trials and others for companies such as Merck, Novartis, Pfizer, GSK, Roche, Aventis, BMS, Amylin, the National Cancer Institute, Astrazeneca,
Quintiles and many others. He has worked with large pharmaceuticals, small biotech, medical devices companies and CROs around the world.
Over the past 10 years, Mr. Morfin has spent more than 50% of his time in Asia (Singapore, China, Taiwan, Malaysia, India, South Korea and Japan
mostly) and has consulted with many companies such as Roche Shanghai, Pfizer Asia Pacific, Novo Nordisk China, Hangzhou MSD, Kanghong
Pharmaceutical, Quintiles, Malaysia Biotech Corp, SFDA, CK Life Sciences, Otsuka and more.
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomanufacturing-asia.com
Dr. Jian Huang, Director, Business Development & Key Account Management, Boehringer Ingelheim Biopharmaceuticals, China
Dr. Huang currently works in Boehringer Ingelheim Biopharmaceuticals Contract Manufacturing Division for Business Development and Key
Account Management for China. She has more than 8 years of BD, sales & marketing experiences in life sciences and pharmaceutical industry.
Prior to BI, she worked in Life technologies (Invitrogen) with various sales & marketing functions. Dr. Huang was trained as a biologist from Johns
Hopkins University School of Medicine

5. Other issues with single-use include
standardization of systems, the
dependability to vendors, and the supply
chain and waste management but if we
can overcome extractables and
leachables, we will eventually be able
to scale up to many thousands of liters.
<Biopharma-Reporter.com, Nov 2014>
IBC’s 5th Annual Biomanufacturing Conference will examine the latest regulations, analyse new and existing facilities, introduce
cost saving technologies, and discuss best practices to meet the growth of biologic products in Asia. Key biological manufacturers
will share their learnings, challenges and strategies to both advance and refine this developing industry. This conference aims
to provide a platform for key industry experts to have in-depth discussions on biomanufacturing facilities, process and quality.
Who Should Attend
Why You Should Attend
Identify new trends and opportunities in biomanufacturing
developments in Asia
Learn from in-depth case studies on investment, construction
and successful operations in China
Gain insights from industry speakers from global and regional
pharma/biotech
Stay abreast of cutting edge technologies and flexible facilities
enhancing biomanufacturing capabilities
2015 Key Conference Themes
Flexible facilities & new biomanufacturing
technologies
Commercialization & scale-up strategies
Global biotech advances
New projects
Biomanufacturing project design & planning
Biomanufacturing finance & investment
Green & energy efficient biomanufacturing facilities
Production & quality
Technology transfer & cGMP
Biomanufacturing supply chain efficiencies
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.biomanufacturing-asia.com
SPONSORSHIP & EXHIBITION OPPORTUNITIES AVAILABLE
For sponsorship opportunities, contact
Yvonne Leong at
Tel: +65 6508 2489
Email: Yvonne.Leong@ibcasia.com.sg
• Showcase latest Biomanufacturing technology
• Meet & network with senior decision makers in Asia
• Position your brand as the market leader and stand out amidst competition
• Generate new business contacts & strengthen existing contacts
19 - 22 May 2015
Grand Hyatt Shanghai, China
Part of
BIOBIO
5TH ANNUAL
IBC
LIFE SCIENCES
BYJOBTITLE
CEOs / VPs / Directors / Heads of
• Manufacturing
• Operations
• Downstream Processing
• Technologies / Scientific Technology
• Biologics
• R&D
• Quality & Regulatory Affairs / Quality Assurance /
Quality Control
• Business Development / Product Development
BYINDUSTRY Biopharmaceutical /
Pharmaceutical /
Biotechnology
Technology and
Solution Providers
CMO
Research Institutes
Government
20%
10%
10%
15%
45%
A key source of growth in biologics over
the next several years will be
Biomanufacturing
<Outsourcing-Pharma.com, Nov 2014>
About the BDP Week
The Biopharma Development & Production Week is the leading
industry platform for pharma, biotech, CMOs, CROs, research
institutes, investors, technology and industry stakeholders to meet,
network and discuss current industry trends, establish business
partnerships and be updated on investment opportunities in
China and surrounding Asia.
BIOBIO3 Conferences
in 1 Location

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Grand Hyatt Shanghai, China
Jin Mao Tower, 88 Century Boulevard
Pudong, Shanghai 200121
Tel: +86 21 5049 1234 | Fax: +86 21 5049 8381
Contact Person: Judy Xu
Email: judy.xu@hyatt.com
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