Biomanufacturing in China: Technologies and Facility Design

Produced by: Associations:

International MarketingPartner:

www.biomanufacturing-asia.com

Increasing Production, Enhancing Quality & Optimizing Operations

Part of

PRODUCTION

BIOPHARMADEVELOPMENT &

WEEK

20 — 23 May 2014Grand Hyatt Shanghai, China

IBC LIFESCIENCES

PLUS:

• WUXI APPTEC • SANOFI • NOVARTIS

• TAKEDA PHARMACEUTICAL • BAXTER

& many more!

BIOBIO4TH ANNUAL

Jingrong Li

Executive Director, Biologics,SIMCERE PHARMACEUTICALS, CHINA

Key Conference Themes:• Regulations, GMP & Standards• Successful Partnerships, Investment

& Financing• Effective Planning, Facility Design &

Development• Improving Operations & Supply Chain

Management• Cost Effective Single-Use Systems &

Technology TransferSteven Lee

Global Head of Biologics Tech Operations &Managing Director,DR. REDDY’S LABORATORIES, SINGAPORE

THE 2014 NEW EXPERT FACULTY INCLUDES:

Ting Xu

Founder & CEO,ALPHAMAB, CHINA Racho Jordanov

President & CEO,JHL BIOTECH, TAIWAN

PRE-CONFERENCE WORKSHOP: 20 MAY 2014Biomanufacturing Technologies & Facility Design

POST-CONFERENCE WORKSHOP: 23 MAY 2014Meeting International Quality & Regulatory

Requirements in Biomanufacturing

Media Partners:

Jeremy Caudill

Global VP Business Development,SAMSUNG BIOLOGICS, KOREA

Darren Ji

Global Head, Asia Emerging Markets Partnering,F. HOFFMANN-LA ROCHE, CHINA

LifeSciences

REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.biomanufacturing-asia.com

12.50 Networking Lunch & VIP Tables

VIP Table 1: Jian Dong, Deputy General Manager, SHANGHAI UNITEDCELL BIOTECHNOLOGY, CHINA

VIP Table 2: Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS, KOREA

If you would like to be seated on a table with the above guests in anexclusive lunch setting, please register your interest [email protected]. Limited seats are available!

2.30 Examining the Impact of the US H.R. 3204 Drug Quality & SecurityAct in the Biomanufacturing Industry• What are the substandard or counterfeit medicines & where are

counterfeit medicines found?• To what extent could substandard medicine be considered as

counterfeit & what should be done to ensure the safety, efficacy &quality of medicines?

• Dealing with corruption & conflict of interest & what consumersshould do?

• How to boost security in the biopharmaceutical supply chain?• Understanding the effects of traceability requirement in the supply

chain partners & pharmaciesMasih Sabet, Associate Director, Quality Assurance, UCB, CHINA

PARTNERSHIPS, INVESTMENT & FINANCING

3.00 Critical Success Factors for Choosing the Right BiomanufacturingOutsourcing Partner• What are the essential partner attributes to look for when selecting

a partner?• Identifying the best technology capacity• Determining the partner’s expression platform• Maximizing the outsourcing opportunities in AsiaKang Li, Head of Biologics, BEIGENE, CHINA

3.30 Afternoon Networking & Refreshment Break

4.00 What do Investors Look for When Investing in BiologicsManufacturing?• Examining business models & growth strategies• Attracting foreign investors• Ensuring financial security in the biomanufacturing business• Selecting & managing partners

~ Prototyping~ Negotiating

Steven Lee, Global Head of Biologics Tech Operations & Managing Director,DR. REDDY’S LABORATORIES, SINGAPORE

4.30 Venture Capital & Private Equity in the Biomanufacturing Space –What are the Experiences & What is the Future for Investors?• Understanding the growing pipeline of biologics portfolio• What are the current trends in the biomanufacturing industry in

Asia?• What are the investment opportunities for entering the

biomanufacturing market in China as compared to other countriesin Asia?

• What are the risks involved in investing in the biomanufacturingindustry?

Panelists:Ramesh Rajentheran, Head of Asian Healthcare Investment Banking,BARCLAYS, HONG KONGNisa Leung, Managing Partner, QIMING VENTURE PARTNERS, CHINAJason Mann, Managing Director, FENEX CAPITAL MANAGEMENT,HONG KONG

5:30 Chairperson’s Summary of Day One

6.00 Speed Networking & Networking Cocktail

VIP 1: Atul Deshpande, Associate Director, Unit Strategy Officer,Asia Pacific, SANOFI, CHINA

VIP 2: Sune Duus Svenningsen, Head of Operations, Asia Pacific,NOVARTIS, CHINA

Exclusive to Registered Participants Only: Limited Spots Available!Participants have the chance to spend two minutes getting to knowthe below key experts in the Biopharma Industry! Secure your placetoday with [email protected]

7.00 End of Conference Day One

DAY ONE 21 May 2014 | Wednesday

08:00 Registration Opens & Morning Coffee

08:50 Welcome Address from IBC Asia & Ice Breaker

Exchange Business Cards & Get To Know Industry Peers

09:00 Chairperson’s Opening Remarks

BIOPHARMA VISIONARY KEYNOTE SESSIONS

09:05 Global Biopharma Outlook• Trends in the global biopharma industry• Priorities of investment in China & opportunities for growth• Challenges & opportunities in the Asian region• The role of Biosimilars in the region’s biopharma industry• Key criteria to further the development of the sector in China and

AsiaModerator:Scott Liu, CEO, HENLIUS PHARMACUETICALS, CHINAPanelists:Youling Wu, CEO, ZHEJIANG TERUISI, CHINAJianguo Yang, Principal Scientist, SANOFI GENZYME, USAJeremy Caudill, Global VP Business Development, SAMSUNGBIOLOGICS, KOREAAbdullah Baaj, CEO, BOSTON ONCOLOGY, USASameer Agarwal, Senior Vice President, Business Center StrategicMarketing, Business Unit Generic Drugs & Standard Solutions, FRESENIUSKABI DEUTSCHLAND GMBH, GERMANY

09:50 Biopharma Regulatory Updates & Development• Clinical approvals for biopharmaceuticals• Regulatory differences between the FDA/EMA/ICH & local agencies

in China & other emerging markets such as India & SEA• How to demonstrate process consistency & what is required?• Accelerating IND applications• Updates on Biosimilars guidelines in key Asian marketsPanelists:Victoria Elegant, Vice President, Medical & Regulatory Affairs, BAXTER,CHINAAndrea Laslop, Head of Scientific Office, AUSTRIAN AGENCY FORHEALTH AND FOOD SAFETY (AGES) PHARMMED, AUSTRIA & AustrianMember, Committee for Human Medicinal Products (CHMP), EUROPEANMEDICINES AGENCY (EMA), AUSTRIADr. Arvind Mishra, Global Head of Quality & Regulatory & Head of StrategicBusiness Unit, Biologicals, CADILLA PHARMACEUTICALS, INDIA

BIOPHARMA TECHNOLOGY SHOWCASE

10:30 Cutting Edge Solutions & Innovation in BiopharmaIf you have leading edge technology & solutions & would like toshowcase your innovation in front of biopharma industry stakeholders,please contact Yvonne Leong: [email protected]

11:00 Morning Networking & Refreshment Break

11.45 Chairperson’s Opening RemarksJeremy Caudill, Global VP Business Development, SAMSUNGBIOLOGICS, KOREA

QUALITY & GMP STANDARDS

11.50 Bridging the Quality Differences of China GMP Standards vs. Europe& the US• Examining the quality assurance procedures• Analyzing the facility requirements• Assessing differences in standards• Determining the effects vs. quality of products outsourced from

ChinaJingrong Li, Executive Director, Biologics, SIMCERE PHARMACEUTICALS,CHINA

12.10 Developing a Multiproduct Facility for Biosimilars According toGMP Standards• Risk management techniques during design• Does the multiproduct facility affect the product?• Cleaning validation study for multi-product equipment• Identifying the best multiproduct facility management strategiesShaligram Rane, Vice President, Quality, INTAS PHARMACEUTICALSLTD, INDIA

12.30 The US FDA Quality Inspection Standards for Biological ProductsManufactured in China• Examining the facility, management & control system• Ensuring the quality of the biological products manufactured in

China are up to US FDA standards• Comparing how the US FDA & CFDA define a state of control for:

~ Plant layout~ Smooth work flows~ Efficient documentation systems~ Well controlled processes

• What are the strategies on how to prepare for an inspection?• How to deal with the inspector? What to communicate & how to

communicate effectively with an inspector?Shaoyu Chen, Managing Director, China Food & Drug Practice,COVINGTON & BURLING LLP, CHINA & Former, Assistant Chief Counsel,FOOD AND DRUG ADMINISTRATION, USA

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12.00 Networking Luncheon & VIP Lunch Tables

VIP Table 1: Sune Duus Svenningsen, Head of Operations,Asia Pacific, NOVARTIS, CHINA

VIP Table 2: Darren Ji, Global Head, Asia & Emerging MarketsPartnering, F. HOFFMANN-LA ROCHE, CHINA

If you would like to be seated on a table with the above guests in anexclusive lunch setting, please register your interest [email protected]. Limited seats are available!

BIOMANUFACTURING TECHNOLOGIES & TECHNOLOGY TRANSFER

2.00 Developing a Robust Commercial Process for Technology Transfer:

Ensuring Product Comparability to Avoid Rejection

• Comparative protocols to demonstrate the same quality of productsproduced

• What could be the impact of technology transfer?~ Manpower~ Cost~ Quality

• To what extent can the R&D process be copied?Rajeev Soni, Associate Vice President, Research & Development, BIOCON,INDIA

3.00 Afternoon Networking & Refreshment Break

3.30 To What Extent Could Disposable Technologies Be a Commercial

Manufacturing Technology in China?

• What are the requirements from the government?• Examining the validation of lethable and extractable. Is it safe to

do?• Examining the growth potential & opportunity for disposable

technologiesPanelists:Lei Sun, Vice President, Technology & Manufacture, AUTEKBIO, CHINAJason Li, Senior Director, Downstream Processing, GENOR BIOPHARMA,CHINARacho Jordanov, President & CEO, JHL BIOTECH, TAIWANJimmy Li, Executive Director of Biologics & Bioprocesses, WUXI APPTEC,CHINA

ROUND TABLE DISCUSSIONS

4:30 Round Table Discussions

Financing & Investment Opportunities in the Biomanufacturing

Industry

Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT,HONGKONG

Examining Disposable Solutions

Jason Li, Senior Director, Downstream Processing, GENOR BIOPHARMA,CHINA

Optimizing Operations in Biomanufacturing

Sune Duus Svenningsen, Head of Operations, Asia Pacific, NOVARTIS,CHINA

Limited Seats Are Available! Secure your place [email protected]

5:30 Chairperson’s Summary of the Day & End of Conference


DAY TWO 22 May 2014 | Thursday

08.55 Chairperson’s Opening Remarks

Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS,KOREA

BIOMANUFACTURING PLANNING, FACILITY DESIGN & DEVELOPMENT

09.00 Setting up A Vaccine Manufacturing Facility in China: What to Do

& What to Expect?

• Overview of the China vaccine market• Identifying the key success factors to set up a vaccine business in

China• Understanding the business penetration model in China• What are the innovative approaches & best practices in vaccine

manufacturing?Homer He, Vice President, SHANGHAI LEIYUNSHANG WEST

PHARMACEUTICAL & General Manager, SHANGHAI JINGAN

PHARMACEUTICAL, CHINA

9.20 Biomanufactuing Production Capacity Planning, Scale Up &

Development

• Production capacity planning & considerations• Successful comparability study design between pilot scale &

commercial scale• Determining the proper commercial scale in biologics

~ Designing & planning procedures• Reducing animal source materials in biomanufacturingYong Ho Ahn, Vice President & Head of Biosimilar & Process Development,HANHWA BIOLOGICS, KOREA

9.40 Opportunities & Development for Follow-on Complex Biologics

Production

• In depth understanding of complex biologics, Abetacept• Understanding the development of Abetacept biosimilar• Analysing the QbD approach during Abatacept developmentTing Xu, CEO & President, ALPHAMAB, CHINA

10:00 Morning Networking & Refreshment Break

OPTIMIZING OPERATIONS & SUPPLY CHAIN MANAGEMENT

10.30 Improving Quality Control & Maintenance of Global Biological

Product Distribution

• Engaging the different distribution channels• Warehousing & distribution procedures• Appropriate storage condition• Engaging third party suppliersGalatia Chandra, Head of Sales & System, Global Operation,KALBE INTERNATIONAL PTE LTD, INDONESIA

11.00 Best Practices in Cold Chain Temperature Mapping for

Biopharmaceutical and Pharmaceutical Products

• Analyzing the importance of cold chain temperature mapping inbiomanufacturing

• Understanding complexities of the supply chain• Is there an overlap between GDP & GMP?• What are the bulk pharmaceutical shipment systems between

upstream & downstream processing facilities?Omar Tabanjeh, Associate Director, Head of Quality Assurance, MiddleEast, Turkey & Africa, TAKEDA PHARMACEUTICALS, UAE

11.30 Analyzing the Biomanufacturing Supply Chain Challenges &

Potential Solutions

• How regulatory challenges affect launching new products in termsof patency & GMP issues?

• What are the financial risky challenges that shape the supply chainstrategy in case of unexpected currency change rates?

• How politics influence the Supply Chain Manager’s decisions?• Contracting & importing biopharmaceuticalsMina Ghaly, Head of Procurement Office, EVA PHARMA, CHINA

Biomanufacturing Technologies & FacilityDesignThe purpose of this workshop is to acquaint the participant withcurrent technology trends in biomanufacturing and key facility designconcepts.

8.30 Registration

8.50 Introduction

9.00 Session 1: Biomanufacturing Landscape in China• Existing biomanufacturing facilities in China• Recent additions and on-going plans for new facilities

10.00 Session 2: Facility Size & Scales• Factors to consider in deciding manufacturing scales• Large vessel vs multiple smaller vessels?

10.45 Coffee Break

11.15 Session 3: Manufacturing Technologies: Disposable vs.Stainless Steel• Pros & cons of disposable & stainless steel facilities• How should the decision be made – factors to consider?

12.00 Networking Lunch Break

13.30 Session 4: Facility Design – Basic Concepts• Key concepts for facility design• Facility design steps & timelines

14.30 Session 5: Facility Design – Process Design Concepts• How should process design integrate with facility design?• Process design principles

15.00 Coffee Break

15.30 Session 6: Design of Drug Product (Fill Finish) Facility• Challenges in drug product facility design• Examples of a drug product facility

16.15 Session 7: Facility Start-Up & Commissioning• Key activities/milestones in facility start-up• Case study: 1st cGMP biologics facility start-up & commissioning

17.15 Closing Remarks & End of Workshop

Meeting International Quality & RegulatoryRequirements in BiomanufacturingThe purpose of this workshop is to acquaint the participant with astrong understanding of how to improve their regulatory submissions& quality systems, & how to successfully pass a foreign inspection.

8.30 Registration

8.50 Introduction

9.00 Session 1: Preparation of Clinical Trial Applications (CTA)• CTA & Investigational New Drug (IND) applications for Europe &

the US• Guide to the preparation of documents• Key issues and common pitfalls

10.00 Session 2: Good Record Keeping in Support of RegulatoryApplications• Understanding the value of development reports• Key writing skills for clear communication

10.30 Coffee Break

11.00 Session 3: Drug Master Files & Facility Registration• Types of drug master files in Europe and US• How to prepare & submit a master file?• How to register your facility?

12.00 Networking Lunch Break

13.30 Session 4: Quality Systems• Key Quality Systems for international cGMP• How to establish & organize your quality program?

14.30 Session 5: Current Quality Issues• Current topics in Quality Assurance• Examples & case studies of real problems

15.00 Coffee Break

15.30 Session 6: Preparing for Inspections & Audits• How to prepare your company for foreign inspections and audits?• How to work with inspectors & auditors?• How to reply to observations?

16.30 Session 7: cGMP Facility Design• Variations in requirements between different regulatory agencies• Basic principles for facility• Review of facility examples

17.30 Closing Remarks & End of Workshop


WORKSHOPS

PRE-CONFERENCE WORKSHOP: 20 MAY 2014 • Tuesday POST-CONFERENCE WORKSHOP: 23 MAY 2014 • FRIDAY

Jincai (Jimmy) Li

Executive Director of Biologics & Bioprocesses,WUXI APPTEC, CHINA

Scott M. Wheelwright

Co-Founder & Principal Consultant,COMPLY ASIA CO. LTD, CHINA

About Your Workshop Leader About Your Workshop Leader

Dr. Jincai (Jimmy) Li is responsible for cell culture process development as wellas operation of the non-GMP pilot plant. He has extended experience in bothmammalian cell culture and microbial fermentation. His expertise includesrecombinant protein, especially monoclonal antibody expression and processdevelopment, scale-up, technology transfer, process characterization andvalidation, as well as post-marketing process improvement. Before joiningWuxi, Dr. Li was Sr. Engineer and Group Leader at Genentech Inc., where heled a group responsible for cell culture process development. He participatedin multiple monoclonal antibody therapeutic projectsí cell culture processdevelopment, clinical material production, IND submission and also in severalPhase III as well as post-marketing products’ tech transfer and processcharacterization/validation work. In addition, Dr. Li was also a core memberof the team that developed Genentech’s next-generation chemically-definedcell culture medium and process platform, and his team developed the record9+ g/L cell culture process at Genentech. Before Genentech, Dr. Li also workedat Tanox, Inc., where he led the manufacturing sciences group supporting PhIIIproduction of a mAb product, and at Diversa Corporation (now Verenium), incharge of process development for multiple recombinant enzyme projects.Dr. Li is the author of over a dozen peer-reviewed publications and patents.

Dr. Wheelwright has 30 years of hands on expertise quality assurance, regulatory,manufacturing and process development. He has directly participated indeveloping oncology, infectious disease, cardiovascular, wound healing,angiogenesis, vaccine and diagnostic products. Dr. Wheelwright has been anexecutive officer in several biotech startups, and has supervised the areas ofmanufacturing, process development, compliance, quality assurance, qualitycontrol, validation, engineering and facilities. He has led the development ofseveral products that are now on the market and has led the construction ofmultiple manufacturing facilities that meet cGMP requirements. His corporateexperience includes Abbott, Chiron (now Novartis) and Scios (now J&J). Dr.Wheelwright served as the founding COO for Innovent, a biopharmaceuticalcompany in China, and is founder and president of Strategic ManufacturingWorldwide, Inc., a consulting firm that provides business and technical expertiseto biotech and related industries. Dr. Wheelwright obtained his PhD degreein chemical engineering from the University of California at Berkeley andperformed post-doctoral studies in biophysics at the Max Planck Institute inGermany. He is the author of a book on protein purification and has publishedmany papers on process design, manufacturing, and compliance forpharmaceuticals and biologics.

PRE-CONFERENCE WORKSHOP: 20 MAY 2014

POST-CONFERENCE WORKSHOP: 23 MAY 2014


About the BDP WeekThe Biopharma Development & Production Week isthe leading industry platform for pharma, biotech,CMOs, CROs, research institutes, investors and industrystakeholders to meet, network and discuss currentindustry trends, establish business partnershipsand be updated on investment opportunities inChina and surrounding Asia.

Visit www.biopharmaproduction.com for moreinformation.

Co-Located with:

30+ Top Level SpeakersNew Pre & Post Interactive Workshops4 Interactive Panel DiscussionsHot Topic Round Table DiscussionsMeet the Experts Via Specially Hosted VIP Lunch TablesSpeed Networking SessionsMorning Ice Breaker & Get to Know your PeersConference Cocktail

Acceleron Pharma • AlphaMab • Amgen • Autekbio • Bayer HealthCare • Berna Biotech Korea • Biopharm Services • BioPharmaNeer Alliance • BioprocessingTechnology Institute • Boehringer Ingelheim • Bristol-Myers Squibb • Celltrion Healthcare • Chugai Pharmaceutical • CMC Biologics • CMC Biologics •Compliance Concepts International • Daewoong Pharmaceutical • DMS Biotechnology • Dow Corning • ExcellGene • Genor Biopharma • Genzyme/Sanofi •Indian Immunologicals • Innobiologics • Innovent Biologics • Mass Biologics • Novasep • Pfizer Biotherapeutics • Sartorius Stedim Biotech • Saint Gobain •SFDA Training Center • Shanghai Henlius Biotech • Swiss Federal Institute of Technology • Wuxi Apptec • Yooyoung Pharmaceutical & many more

20 — 23 May 2014Grand Hyatt Shanghai, China

Part ofPRODUCTION

BIOPHARMADEVELOPMENT &

WEEK

Asian countries such as India, Singapore, South Korea& China are fast becoming biomanufacturing hubs.Biologics manufacturing is a huge investment & canamount to US10 million or more to construct, equip, &launch a successful certified GMP plant facility(Biospectrum Asia, 2013). With the intensifying growth& demand of biologics production, IBC’s 4th Annual

Biomanufacturing Conference provides a timelyplatform to explore the opportunities & challengesfaced in this sector including:

The investment opportunities for entering thebiomanufacturing market in China & the surroundingAsian region

Bridging the quality differences of China GMPStandards vs. Europe & the US

What is the growth potential & opportunity fordisposable technologies in biomanufacturing inChina?

Identifying the critical factors in choosing the rightoutsourcing partner

Developing a robust commercial process fortechnology transfer

Examining the impact of the US H.R. 3204 Drug Quality& Security Act in the biomanufacturing industry

For sponsorship opportunities, contact Yvonne Leong atTel: +65 6508 2489

Email: [email protected]

BY INDUSTRY■ Biopharmaceutical / Pharmaceutical /

Biotechnology 45%

■ Technology and Solution Service Providers 20%

■ CMO 15%

■ Research Institutes 10%

■ Government 10%

www.biosimilarasia.com

www.celllineasia.com

LIMITED SPONSORSHIP & EXHIBITION OPPORTUNITIES AVAILABLEDo you provide innovative technology to support the biomanufacturing Industry in Asia?

• Showcase the latest technology• Meet & network with senior decision makers in Asia• Position your brand as the market leader to stand out amidst

competition• Generate new business contacts & strengthen existing accounts

Who Should Attend

SNAPSHOT OF PAST ATTENDING COMPANIES INCLUDE:

Abundant Networking Opportunities &Interactive Formats!

An International EventChina, Taiwan, Hong Kong 55%

Europe 10%

USA 5%Australia 5%Southeast Asia 10%

Japan,Korea 10%

India 5%

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Biomanufacturing in China: Technologies and Facility Design

Health & Medicine

Transcript of Biomanufacturing in China: Technologies and Facility Design