4th Annual Bioprocess and Technology 2018

2018年10月31日-11月2日 • 新加坡,One Farrer Hotel & Spa

概要

重新思考技術創新及導入顛覆性製造技術的需求,迫使生物醫藥產業擴大推動業務改善。本會議將討論生物製程未來的疾病或傳染病為基礎的樣貌、以及決定產業新方向的趨勢等議題。第4屆Bioprocess and Technology將齊聚藥廠及技術提供商代表,分享其對生物製程管理整體樣貌及製造領域趨勢的看法。

學會重點

  • 亞洲生物醫藥製造商之製程管理、疫苗製造、營運、品質保證/品質管理等案例分享。
  • 連續生產之技術及投資報酬評估;與傳統批量基礎處理的比較。
  • 聚焦品質和整合性標準,討論平衡各種基準、產品開發策略、CGMP的方法。
  • 監管議題討論,包含釋義、生物製劑指南、調整、疾病監控等議題。
  • 聚焦生物製程技術,討論製造技術趨勢、設備投資、品質與風險、設施等議題。
  • CMO設施的品質標準、六標準差、驗證等行動。

同時舉辦的會議

Biopharma SCMInnovate 2018 >>
Biotech Investment Summit >>

議程

8:00 am

Main Conference Registration and Morning Coffee

8:50 am

Chairperson's Opening Remarks

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS

9:00 am

  • Translational research to understand local unmet medical need
  • Addressing ethnic difference through innovative science and development strategies
  • Contributing to collaborative R&D ecosystem to ensure quality

9:30 am

[Tech Talk] AI in Biopharma - From R&D, Drug Development to Supply Chain

10:00 am

10:40 am

Morning Networking and Refreshment Break End of Plenary Session

11:20 am

Chairperson's Opening Remarks

PROCESS INTENSIFICATION AND COST-REDUCTION STRATEGIES

11:30 am

12:00 pm

  • Technical CMC development for establishing an end-to-end bioprocess strategy
  • Process optimization and process intensification for better efficiency and speed to market
  • Developing an accelerated timeline for biologics development and bioproduction

12:30 pm

  • Growth in diversity of molecules entering the clinical pipeline and improving manufacturing productivity, flexibility, and cost efficiency
  • Implementing different processing tools and manufacturing approaches to achieve improved process outcomes
  • Discussion on existing and new single-use technologies with a focus on the benefits of choosing each processing tool with the goal of achieving desired outcomes

1:00 pm

Networking Lunch

CELL THERAPY AND NOVEL BIOTHERAPEUTICS DISCOVERY

2:00 pm

  • A technology platform for enabling the development of ADCs, bispecifics and multi-binding antibodies in versatile configurations
  • Lead identification and optimization for higher affinity and reduction in potential immunogenicity
  • Enabling higher therapeutic index through optimal disease target engagement

2:30 pm

  • Showcasing a patented nanotechnology for in-situ isolation of donor stem cells
  • Reducing the carcinogenic risk of cultivating NSCs through a specific nanotechnology matrix
  • Improving harvest yield, function and safety for individualized stem cell therapies

3:00 pm

  • Developing novel mAbs and innovative biotherapeutics through Science Based Drug Discovery (SBDD) and Market-Oriented Drug Development (MODD)
  • Accelerating bio-drug development via public-private partnership through KBIO
  • Raising efficiency of new drug development and commercialization

3:30 pm

Afternoon Networking & Refreshment Break

4:00 pm

  • Exploring regenerative effects of BDACs and their demonstrating pericytic identity
  • Engineering BDACs to meet clinical requirements on quantity and short-term availability
  • Designing bio-instructive biomaterials to support BDAC growth and proliferation

LARGE-SCALE CELL CULTURE SYSTEMS AND UPSTREAM OPTIMIZATION

4:30 pm

  • Key considerations for scale-up of cell culture operations and tech transfer
  • Collaborating with global partners to ensure seamless alignment during tech transfer activities
  • In-process control methods for ensuring product safety and consistency

5:00 pm

  • Importance of glycosylation on therapeutic protein
  • Altering the glycans on antibody to enhance efficacy
  • Increasing half-life of biologics through enhancement of specific glycans

5:30 pm

  • Managing commercial scale production for cell-derived biotherapeutics
  • Critical parameters to control, key factors to consider
  • In-process control methods for ensuring cell culture stability and product consistency

6:00 pm

Networking Cocktail

8:50 am

Chairperson's Opening Remarks

OPTIMIZING VIRAL CLEARANCE AND IMPROVING RECOVERY YIELD

9:00 am

  • Overcoming filter fouling in viral clearance studies
  • Critical aspects in virus filtration
  • Comparison of different filter vendors

9:30 am

  • HCPs, DNA and other contaminants form the bulk of process-related impurities that arise from mAb bioproduction
  • Development of a single-use impurities depletion technology to be used under flow-through conditions and during clarification / polishing steps in downstream operations - Case study of implementation done by Sanofi
  • Envisioning its use in an optimized platform with process intensification possibilities or as a unique solution for sample preparation

10:00 am

  • Comparison of current cell harvesting and clarification strategies for mAbs
  • Analyzation of how cell culture parameters influencing the harvesting performance
  • Development of a harvesting guide to take the right way from the beginning to reduce time to market

10:30 am

Morning Networking & Refreshment Break

ANALYTICAL METHOD DEVELOPMENT AND CMC STRATEGIES

11:10 am

  • Critical concepts and MS strategies for analytical method development
  • Introduction of bioinformatics strategies to enable expedient glyco-analysis
  • Application of such strategies to therapeutic recombinant glycoprotein drugs

11:40 am

  • Applying CMC strategies for product development and better upstream & downstream process control
  • Ensuring a strong QbD and compliance focus with key stakeholders, partners and suppliers
  • Ongoing quality improvement and monitoring efforts for site operations
  • Overcoming the challenges for data integrity in line with regulatory requirements
  • Achieving process and manufacturing goals, including site certification

12:30 pm

Networking Lunch

OPERATIONAL EXCELLENCE AND SMART FACILITIES OF THE FUTURE

1:30 pm

  • Integrating process and product design for superior manufacturing process control
  • Utilizing disposable technologies and intensified processes to create cost-effective bioproduction
  • Process optimization and fluid integration of upstream and downstream processes

2:00 pm

  • Applying continuous process improvement activities in the biomanufacturing value-chain
  • Improving manufacturing operations through lean management approaches
  • Driving cost savings initiatives through deviation reduction initiatives

2:30 pm

  • Understanding the complexities and cost drivers associated with vaccine production
  • Strategic planning, design and setup of AJ Biologics's first vaccine facility in Malaysia
  • cGMP considerations and meeting up to international accreditation standards

3:00 pm

  • Process change to maximize raw material yield and improve yield ratio
  • Enhancing operational efficiency and streamlining bioproduction processes
  • Lean management strategies for single-use systems and reduction in OPEX

3:30 pm

Afternoon Networking & Refreshment Break

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 CLOSING PLENARY SESSIONS

4:00 pm

  • Reviewing latest disruptions in the biopharma industry
  • Re-thinking manufacturing productivity and quality
  • Connecting human resources, data, machines and networks for better outcomes
  • Impacts of Industry 4.0 on drug financing and investment outlook
  • Data management, product traceability and supply chain security

5:00 pm

Chairperson's Summary and End of Main Conference Day Two

9:00 am

The workshop will give an overview on viral clearance principles and global regulatory requirements for all biopharmaceuticals like recombinants, vaccines, plasma products and animal/human tissue derived biologics. Best approaches for viral clearance studies particularly for recombinant products will be detailed and discussed and the effectiveness of frequently analyzed virus inactivation- and virus removal steps will be described.

Key learning outcomes:

  • Background on viral clearance
  • The right viral clearance study design
  • Viral clearance effectiveness

1:00 pm

End of workshop

贊助商募集

建構合作關係並提升知名度的機會。
做為贊助商參加本會議,可確保在生物醫藥界供應鏈市場做為領導企業的地位,提升品牌認知度,另外還有促進行銷機會的各種方案。詳情歡迎來信或來電詢問。

演講者

Ming-Qiang Zhang 4th Annual Bioprocess and Technology 2018

Ming-Qiang Zhang

Vice-President, Research & Development, Amgen, China

Dr. Carl Firth 4th Annual Bioprocess and Technology 2018

Dr. Carl Firth

Founder and Chief Executive Officer, Aslan Pharmaceuticals Pte Ltd, Singapore

Piers Ingram 4th Annual Bioprocess and Technology 2018

Piers Ingram

Chief Executive Officer, Hummingbird Bioscience, Singapore

Jinpian Diao-Piezunka 4th Annual Bioprocess and Technology 2018

Jinpian Diao-Piezunka

Head of Bioprocess Development, Sanofi, France

Jonathan Zhao 4th Annual Bioprocess and Technology 2018

Jonathan Zhao

PhD, Co-founder and Chief Executive Officer, Hangzhou JUST Biotherapeutics, China

Ryan Viegas 4th Annual Bioprocess and Technology 2018

Ryan Viegas

Head of Logistics - APAC, Teva

Subhasis Banerjee 4th Annual Bioprocess and Technology 2018

Subhasis Banerjee

Associate Director, Manufacturing Sciences & Technology, MERCK

Per Karlberg

Business Leader Customized Bioprocess Solutions, GE Healthcare Life Sciences

Art Hsing-Mao Chu 4th Annual Bioprocess and Technology 2018

Art Hsing-Mao Chu

Director of Research, Immunework, Taiwan

Ken Yung 4th Annual Bioprocess and Technology 2018

Ken Yung

Professor and Associate Head, Department of Biology, Hong Kong Baptist University, Hong Kong

Daeyoung Kim 4th Annual Bioprocess and Technology 2018

Daeyoung Kim

Principal Researcher, Division of Discovery & Optimization, New Drug Development Center, Osong Medical Innovation Foundation (KBIO), Korea

Anna Maria Blocki 4th Annual Bioprocess and Technology 2018

Anna Maria Blocki

Assistant Professor, Institute for Tissue Engineering and Regenerative Medicine (ITERM), Hong Kong

Ziliang Liu 4th Annual Bioprocess and Technology 2018

Ziliang Liu

Biological Technology Transfer Supervisor, BeiGene, China

Pao Chun Lin 4th Annual Bioprocess and Technology 2018

Pao Chun Lin

Associate Staff Scientist, Bioprocessing Technology Institute, Singapore

Praveen Gupta 4th Annual Bioprocess and Technology 2018

Praveen Gupta

Head of Upstream Process Development, Mammalian & Microbial, Biosimilars, Intas, India

Horst Ruppach 4th Annual Bioprocess and Technology 2018

Horst Ruppach

Scientific Director Viral Pathogen Safety, Charles River, Germany

Fabien Rousset 4th Annual Bioprocess and Technology 2018

Fabien Rousset

Head of Bioseperations Business Unit, Daicel Bioseparations, France

Silke Bergheim-Pietza

Global Product Manager Pre- and Depth Filtration, Pall Biotech

Terry Nguyen-Khuong 4th Annual Bioprocess and Technology 2018

Terry Nguyen-Khuong

Associate Staff Scientist, Bioprocessing Technology Institute, Singapore

Venu Mallavarapu 4th Annual Bioprocess and Technology 2018

Venu Mallavarapu

Head, Operational Excellence, Lonza, Singapore

Christian Cater 4th Annual Bioprocess and Technology 2018

Christian Cater

Head of Operational Excellence, Roche, Singapore

Liang Tang 4th Annual Bioprocess and Technology 2018

Liang Tang

Vice President of Biologics Development and Manufacturing, WuXi Biologics, China

Joseph Albert 4th Annual Bioprocess and Technology 2018

Joseph Albert

Chief Technical Officer - Engineering and Projects, AJ Pharma Holding, Malaysia

舉辦日期與會場

2018年10月31日-11月2日

One Farrer Hotel & Spa
1 Farrer Park Station Road
Singapore 217562

Contact Person: Daniel Koh
DDI: (+65) 6705 7884
Fax: (+65) 6834 7892
Cell: (+65) 86870123
Email: danielkoh@onefarrer.com

合作夥伴

Supporting Association

The New Drug Founders Club was founded in March, 2015, to form a network for founders of companies focusing on innovative new drug R&D and of companies providing relevant services. The club is highly prestigious in that only founders of such companies and people well-recognized for having special and major contributions to new drug R&D in China (including China R&D heads of multinational companies, R&D heads of major domestic companies, partners of VC, and other nationally recognized leaders in new drug R&D) can be admitted to the club. This feature distinguish this club from any other professional organizations in China or the world. Currently there are about 235 members in the club, with several new applications reviewed for approval every month.

Media Partners

APBN serves as a knowledge exchange platform (print online) to provide latest news noteworthy information in biotechnology, healthcare, biomedical pharmaceutical industry in Asia Pacific. Established in 1997, APBN is the first only monthly magazine focused on biotechnology, healthcare, pharmaceutical life science developments in China other Asia Pacific countries. The main motivation of APBN is to bring biotechnology news in a comprehensive concise manner to, but not limited to, clinicians, research scientists, students, other industry professionals experts.

Bentham Science Publishers is rendering a vital service in the quality publication that publishes over 100 peer-reviewed print online scientific, technical medical journals. These titles are indexed in recognized indexing agencies, such as Science Citation Index®, Journal Citation Reports/Science Edition, MEDLINE/Index Medicus, PubMed, Scopus, Chemical Abstracts, EMBASE etc. Some of the high impact titles which enjoy a wide reach distribution are Current Gene Therapy (Impact Factor 4.906), Current Alzheimer Research (Impact Factor 3.796), Current Medicinal Chemistry (Impact Factor 3.715), other popular titles.

Bentham has an extensive library of eBooks in the areas of science, technology, medicine, social sciences humanities. Bentham eBooks publishes monographs, h books, conference proceedings, textbooks, review volumes, biographies autobiographies.

Biocompare.com is the leading resource for up-to-date product information, product reviews, new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products new technologies with the power of the Internet to offer scientists the most dynamic, relevant, innovative media-based marketplace for life science information.

Established since 1998, Bio-Equip is a leading website for lab equipments, reagents, consumables bio services. Our users come from different fields like life science, medical research, pharmaceutical, biotechnology, modern agriculture, food safety environment monitoring. Bio-Equip offer users a complete product directory which involves 158 product ranges among lab equipments, reagents, consumables, lab animals, bio services, cell lines, bio software books.Serving users through two websites, www.bio-equip.com (Chinese) www.bio-equip.cn (English), we own over 20,000 registered suppliers more than 500,000 pieces of product technical service information with details of product description, price, sample downloading, technical articles videos.

BiotechEast provides information services related to Taiwan's growing life science industries. Our services cover a wide scope, including marketing business intelligence, investment sourcing, partner identification vetting. Founded in 2003, our mission is connecting Taiwan overseas companies within this industry space, for the advancement of medical technology the benefit of patients everywhere.

SOURCE newswire provides comprehensive coverage of breaking news for the life sciences industry in China. Daily updates allow timely tracking of key company developments, deal-making, regulatory trends, with the primary focus on the pharmaceutical industry.

  • Daily News Briefs: receive 3-4 original articles each day
  • Email alerts on topics of interest by keyword.
  • Access a fully searchable archive of 20,940 original articles
  • Filter news by story type: company news; product/R&D trends; pricing reimbursement decisions; general policy developments
  • Ability to save share favorite news items

 

KONGPOSH Publications is one of the leading Pharma publishers of India. Our publications are – The Pharma Review® is a bi-monthly article based journal. Covering news, views articles on various fields of pharmacy including Clinical Trials, Biotechnology, Review/Research papers, Herbal Medicine much more. Contributions received from Eminent pharma personalities from India as well as other countries which helps us to have a varied rich content matter. Participation distribution in over 20 Expos & Conferences worldwide each year. It is widely read by decision makers, middle management the academia. The journal is Abstracted & Indexed in International Pharmaceutical Abstract & Chemical Abstract - USA, Index Copernicus - Pol & Ulrich’s Journal Database – USA for the quality of its content. Also available on our website E-book format.

For regular complimentary link of the journal write to us on kongposhpub@gmail.com.

Lingmed Ltd was founded in 2013 in Hong Kong, currently we have offices in Shanghai Beijing. Lingmed promotes three leading intelligence databases for healthcare professionals in China to make better decisions. Lingmed’s core products are healthcare intelligence databases; it covers global innovative assets & China market intelligence. Lingmed’s Products Services have been recognized by Fortune 500 multinational pharma device companies as well as Chinese local big pharmacos. In addition, we together with our partners in Europe provide partnering services to bridge European Chinese pharmaceuticals with biotech companies, including valuation market monitoring reports.

Pharma China (www.pharmachinaonline.com) is the most trusted English media business intelligence service covering the Chinese pharmaceutical / biopharmaceutical industry market.

Pharma China caters for the growing needs of the international pharmaceutical industry for up-to-date insightful information intelligence on China's burgeoning but increasingly complex healthcare marketplace, is subscribed by most multinational pharmaceutical companies, leading CROs, investment banks consulting firms active in China as well as relevant industry associations government agencies.

  • Pharma China Journal Edition (monthly in PDF Print)
  • Pharma China Web Edition (continuously-updated news, in-depth commentaries online databases)
  • China Pharmaceutical Guide (the most comprehensive authoritative reference for China's healthcare sector)

Informa's Pharma Intelligence is the trusted partner of the top 50 global pharmaceutical companies the top 10 contract research organisations (CRO's) - providing timely intelligence insight to help them make authoritative decisions.

From drug device discovery development to regulatory approval, drug reimbursement to lifecycle management - we provide the global intelligence insight to help advance our partners' initiatives in a fast changing market.

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing business development worldwide.

Actively supporting all forms of partnering in- out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thous s of industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

Technology Networks scientific communities offer today's scientists a single resource that contains unique, engaging, entertaining content from their field of research.

World Pharma Today is a magazine online avenue, a boulevard of the latest happenings in the pharmaceutical sector around the world. Our audience comprises of experts prominent decision makers of the Pharma sector we consider it as our duty to provide them with the current changes in the industry. We provide B2B media services boosting your online presence increasing your visibility manifold.

 

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