In-Person Networking Hours
The 10th Annual Biologics Manufacturing Asia 2023 is Asia’s bioprocessing-focused, knowledge-sharing conference that provides regional biopharmaceutical industry stakeholders a carefully tailored networking platform for leveraging opportunities for strategic collaboration, and exposure to the latest manufacturing technologies and know-how. We have an agenda built around success stories from Asia’s biopharmas as well as the technical expertise from International Biopharmas and BIG Pharmas, presentations on the latest manufacturing technologies such as single-use and end-to-end continuous processing for biologics, today’s challenges and opportunities in biomanufacturing, advances in upstream process development, cost-optimization strategies in downstream processing, analytical characterization strategies, facility design, and scale-up strategy, fill & finish innovation to streamline the operations amongst other crucial themes.
Along with the Asia Biologics Festival, the BMA 2023 is co-located with 2nd Aseptic Fill Finish and Packaging, 7th Annual Biologistics World Asia conference, and the iconic in-person Asia-Pacific Bioprocessing Excellence Awards 2023.
Senior Vice President, Corporate Operations, Gilead Sciences
Executive Vice President & Chief Quality Officer, Samsung Biologics
Experienced Quality, Operations and Business Executive with ability to lead diverse teams of talents to new levels of success in a variety of highly competitive businesses. Solid life science business skills with the right mix of intelligence and emotional strengths and a proven track record of accomplishments and results.
More than 32 years of experience in business strategic planning and execution, business and functional units development, project and program management, and life science quality & regulatory compliance. Solid track record in leading life science companies (Pharma, MedTech and Biologics) in North America, Europe, Middle East and APAC through license pre and post-approval regulatory inspections and drugs and devices speed to market. Excellent understanding of global competitive dynamics of science and non science-based businesses. Supported various M&As, including playing the lead role (2016 & 2017) in identifying and securing a $5.5B target acquisition - adding more than $5B to the acquiring company's market cap post acquisition.
Strong believer that, for a competitive advantage to last, companies must balance between doing great financially and doing good helping communities around the world live better lives.
Global Subject Matter Expert Analytical Validation & Lifecycle, GSK,
President, Chugai Pharma Manufacturing Co., Ltd.,
Zorica Dragic Arunasalam
Head of Cell Line Screening and Development, Novartis
Senior Staff Scientist, Regeneron Pharmaceuticals, Inc.,
General Manager, Emre Ecza
Director of Process Development, Amgen
Yang Yuan Sheng
Lead Scientist, Group Leader, Cell Line Development, Bioprocessing Technology Institute, A*STAR
Sang Min Lee
Director, Process Development Team, Samsung Bioepis
Dr Elena Smith
Deputy Director, Analytical Expert - Quality, Sanofi
Won Min Kim
Assistant Manager/Bio-Process Team, Manufacturing Department, Celltrion Pharm
Senior Technical Expert, Field Technology Management Asia Pacific, Process Solutions Services, Merck KGaA
VP of Biomanufacturing, Bio-Thera Solutions, Ltd.,
Director, Market Access & Government and Regulatory Affair, AstraZeneca
Distinguished Consultant, Development Center for Biotechnology
Swapan K Jana
Director - R&D and Manufacturing, Serum Institute of India Pvt. Ltd.
CEO, Paras Biopharmaceutical
Head-Formulation, R&D- M.Tech- CMC, Sanofi Healthcare
Chris Siew Chong LEE
Site Head, WuXi Biologics
Vice President, Drug Substance, Biocon
Senior Vice President, YZY Bio
Director Of Manufacturing, Cerecin
- 14 years experience in Manufacturing, Procurement, and Supply in Pharmaceuticals and Nutraceuticals across different product portfolios (Injectables, Medical Devices, API, Health Supplements)
- Currently works as a Manufacturing Director at Cerecin, a brain health company involved in the development of novel evidence-based therapeutics and products that are designed to target conditions ranging from memory impairment to Alzheimer’s disease and other neurological diseases.
- Holds a Bachelor of Engineering and Masters of Science degrees in Chemical Engineering, and a Master of Business Administration. Also is a PMP certified professional!Murali Nair
Senior Vice President, Hetero Labs Limited
Site Head and Vice President, Operations, Lupin Limited
Chandrakant Kathote serves as a Site Head for Lupin’s Biologics facility at Pune, India.
Chandrakant has played Leadership roles in managing multi-site manufacturing operation for Drug substance, Drug Product and Devices through Mammalian and Microbial platform technology. Chandrakant has wide experience in large scale manufacturing of Biologics and small molecules, from clinical phase to commercialization in the US, EU and Japan. Chandrakant led several regulatory Inspections from US, EU, Japan and other geographies leading to successful approvals. He has gained significant understanding on process development, technology transfer, regulatory and quality requirements for Biologics manufacturing. To manage long term supply plans, he led several green field and brown field capacity expansion projects for Biologics and small molecules, including outside of India. Chandrakant Championed several Operational Excellence projects for Biologics and small molecules. He has significant experience in driving several cost reductions projects.
Chandrakant holds a master’s degree in Bioprocess technology from Institute of Chemical Technology, Mumbai and completed on-campus Executive General Management Program from IIM Bangalore.
President, AlaMab Therapeutics Inc.,
MD Atiqur Rahman
Senior Executive Officer, Production (Sterile), Incepta Pharmaceuticals Ltd.
Technology Pharma Bioprocess Development, Roche
Co-Founder and CEO, Novasign GmbH
With more than 10 years of experience, Mark is a passionate expert in biopharmaceutical process development. He worked together with several Top25 Pharma companies in different projects, targeting their process development and understanding needs. Leading Novasign as CEO, Mark develops a hybrid modeling software for both up and downstream processes together with his team. This software utilizes AI applied to process data and first principle models (hybrid models) to faster and better predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization are accelerated significantly while a better process understanding is gathered. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development
Senior Manager Production (Sterile), Brookes Pharma Karachi
Head of Institute of Bioprocess Science and Engineering, Department of Biotechnology, University of Natural Resources and Life Sciences
Director R&D, MSAT & Process Development, Biocon Biologics
- Experience of 20 years as bio-pharmaceutical professional with expert knowledge on scientific, pharmaceutical and health-care sectors coupled with an astute business acumen. including process development, technology transfer, manufacturing science and technology. project planning and CMC
- Extensive knowledge on process development and manufacturing scale up of recombinant protein production including Insulin and Insulin analogues to up-to 50kL scale. As manufacturing Process lead, enabled Quality by design (QbD), through detailed process characterisation, scale-down model qualification, process performance qualification, cleaning validation and continuous process verification
- Interfaced with regulators as process technical lead towards successful product approvals received from US-FDA, EMA, COFEPRIS, ANVISA, NPRA.
- Involved in continuous process improvements towards reduction in COGs and increase in productivity, enabling efficient comparability package for seamless approvals.
- Generated publications and patents on purification of peptides, Insulin and Insulin analogues
Scientist, Process Development Analytics, Bristol-Myers Squibb Co.,
Helen Zhao is a scientist in Process Development Analytics at Bristol-Myers Squibb Company at Devens, MA. She has 5+ years of expertise in PAT and specializes in the evaluation, technical transfer and execution of analytical assays for therapeutic biologics.
Head of Production, Hummingbird Bioscience
General Manager, Development Department, R&D Division, KM Biologics,
Vice President, APAC, Astrea Bioseparations Ltd.
A/Prof. Bi Xuezhi
Lead Scientist Group Leader, Analytical Science & Technology (Protein Analytics) Bioprocessing Technology Institute, A*STAR
Vice President, Blue Blood Biotech Corp.
Dr. Lin is a biomedical scientist with over 20 years of commercial process in life science industries, including medical devices, pharmaceutical, biomaterials manipulate technology and biochips.
Prior to joining Blue Blood Biotech Corp., Dr. Lin was the Deputy Project Director of Industrial Technology Research Institute (ITRI), which is a biggest R&D organization in Taiwan engaging in applied research and technical services.
He was responsible for global cooperation in integrates from small to big key account’s company to form a complete strategic alliance. He was Senior VP at Body Organ Biomedical Inc (listed company in Taiwan Stock Exchange Market) with cross continental’s office, covering TWN, China and the Netherlands.
During his around 10 years tenure at BOBC, which proceeded rapidly co-built sales organization operation at the Netherlands including related regulation approval.
He was not only build efficiency way to synergistic clinical trials and marketing tools, but also broadens the sales channels by shifting the company’s focus from ophthalmology oriented to biomaterials.
As a headquarter based in Taiwan, he lead the team to get first grant of SenterNovem from Ministry of Economic Affairs of the Netherlands for 0.3 million Euro with leading multinational research teams of China, Taiwan and the Netherlands in 2009!
He had successfully filing 36 patents with cost effective strategy of joint research in ProTop Mediking Biomedical Inc. In 2000, he initiated and ready for registration of class II medical device in Purzer pharmaceutical company, this is the first bone filler registration in Taiwan.
Dr. Lin was not only earned his Ph.D. from the Institute of Bioengineering in National Taiwan University but also expand his training to business by get a MBA degree from National Chen Chi University.
Jiao Ma, Ph.D.
Senior Scientist, AstraZeneca
Jiao Ma, Ph.D. received her doctoral degree from Harvard University in Chemistry and Chemical Biology. Jiao is currently an analytical scientist at AstraZeneca Biopharmaceuticals R&D, using her expertise in mass spectrometry to perform in-depth characterization of biopharmaceuticals and develop innovative MS-based approaches to support various modalities. Jiao is leading the development of fit for purpose high-throughput host cell protein profiling platform using LC-MS/MS based technology and expanding multi-omics capability within the department. Jiao also has extensive experience in proteomics workflow in both academic research and industry discovery space.
Scientific Director, Amgen
Chief Technology Officer, Harbour BioMed
Sung Ho Hahm
CEO, Rophibio Inc.
Dr. Hahm received Ph.D. degree in biomedical science from Univ South Carolina followed by Postdoctoral training at National Institutes of Health and Staff Fellow at Johns Hopkins Medical School. He has been working as CEO of Rafagen in USA and then as the Founder and CEO of Rophibio in Korea. He has accumulated over 25 years of experience in cellular and molecular biology research and development. At Rophibio, he has been leading technology development in CHO cell-based cell line development and upstream process development for the company’s biosimilars and biopharmaceuticals candidates.
Senior Fellow, Novartis
Gerald currently works as a Scientific Officer at Novartis TRD biologics. He is member of the Novartis ICHQ12 implementation team and co-leads the TRD biologics QbD and Control Strategy initiative. Prior to joining Novartis he gained professional experience in CMC and analytical development during his time at Roche from 2008 to 2015. Gerald currently also represents Novartis in the EFPIA analytical workstream supporting ICH Q2R2 and ICH Q14.
COO/SVP, Trinomab Biotech Co., Ltd.
Dr. Jason is the COO/SVP of Trinomab Biotech Co., Ltd. (Zhuhai, China), and is fully responsible for the operation in anti-infectious Mabs CMC development, preclinical pharmacologic studies, GMP manufacturing and IND regulatory filings. Dr. Li obtained MS (1984) and Ph.D. in biochemistry (1988) from University of Poitiers in France.
In biopharmaceutical area, Dr. Li has 25 years of experience in process design, process development and process validation, technology transfer, quality management, GMP manufacturing as well as FDA/EMA/NMPA regulatory compliance. Overall, Dr. Li participated or led the development of more than 30 biologics at various stages of development, including five in clinical phase III and finally BLA approved by the US FDA (Ibalizumab-TMB355) and the first biosimilar drug marketed in China (Rituximab).
Prior to his current roles in Trinomab, Dr. Li held serval senior management positions at Shanghai Epimab Inc, Henlius Biotechology Inc, and WuXi Biologics Inc., also served the leadership roles at the Dow Chemical Co., Affymetrix Inc, TPI, and Novavax, Inc in USA. Dr. Li has obtained the Six Sigma Green Belt and Project Management Certificate (PMP), 14 US and global patents and has published more than 20 articles in the peer-reviewed international scientific journals. In addition, Dr. Li served as the member of AAPS-MES Committee (2014-2017), chief scientific liaison of the National Biotechnology Council (2016-2017), and the editorial board member of AAPS Journal <Open> (since 2015). In education area, Dr. Li served as an assistant professor of biology in University of Rouen (France), and as associate professor of biochemistry in University of Poitiers (France), was responsible for teaching biology/biochemistry over 3,500 undergraduate and graduate students.
Professor, Institute of Bioengineering College of Chemical and Biological Engineering Zhejiang University
Dong-Qiang Lin, professor at Zhejiang University. He graduated from Zhejiang University in 1992, and then obtained PhD in 1997. Since 1998, he work for Zhejiang University, and became a professor in 2007. He was the director of the Institute of Bioengineering, Zhejiang University. He also worked as post-doctor in Germany and visited Germany and USA several times as visiting professor. Till now he has published three books and more than 160 peer-reviewed papers in international journals, and was authorized 50 patents. In recent years he focused on downstream processing, including new bioseparation technology, continuous biomanufacturing and bioprocess design.
External Affairs, Corporate Quality, Japan Asia Pacific & Intercontinental, Amgen
Dinesh is currently responsible for Amgen’s outward facing efforts in Japan Asia Pacific and Intercontinental Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate and deliver impact in the evolving external GxP landscape.
Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Medicine Regulatory Agency, Health Sciences Authority (HSA). During his 10 years tenure in HSA, Dinesh held many different roles including Senior GMP Inspector. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation and mutual reliance.
Prior to the roles in the regulatory agency, Dinesh held many positions in Biopharmaceutical and Medical Device industries as well as in Academia for over 20 years.
Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is an American Society for Quality Certified Quality Auditor and Biomedical Auditor. He has also earned certifications in Clinical Trials Management and Healthcare Policy and Governance. Dinesh is the immediate past President of PDA Singapore Chapter and he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB).
President, Development Center for Biotechnology
Associate Director of Upstream Process Development, GenScript Probio
Agenda At A Glance
We have an agenda built around success stories from Asia’s biopharmas as well as technical expertise from international biopharmas and Big Pharmas, presentations on the latest manufacturing technologies such as single use and continuous processing for biologics, key challenges in cell therapy manufacturing, cost-reduction strategies in downstream processing, sustainability case studies surrounding single use systems, discussions on vaccine manufacturing, know-how on the developments in pathogen safety amongst other crucial themes.
The 10th Annual Biologics Manufacturing World Asia is the largest and the ONLY bioprocess business and technology convention in Asia Pacific! In 2023, 1000+ biomanufacturing stakeholders from Big Pharmas, Biopharmas, Contract Manufacturing Organisations, Academic & Research Institutes, Regulatory Authorities, Solution Providers across Singapore, China, South Korea, Taiwan, Japan, Australia, India, and SouthEast Asia, will convene hybridly to discover, discuss and debate about biologics manufacturing processes, best practices and latest developments to manufacture biologic drugs cheaper and faster!
Explore the most comprehensive upstream processing from early cell isolation and cultivation, cell line engineering, media development, raw materials considerations and more for enhancing and optimizing cell culture return and production rate with cost-reduction strategy. Know-how on the latest development of upstream processing technologies have evolved and potentially changed the biologics drug manufacturing process to be more economically feasible.
Immerse into the most focused biologics downstream processing with the ultimate goal of meeting quality and purity requirements of biologics drug products. Multiple purification approaches, concentration, product recovery, cost reduction and optimizing the integration of continuous manufacturing and utilization of single use disposable systems to optimize biologics manufacturing process production rate will be discussed.
Analytics & Quality
Innovative strategy of assay optimization, real time monitoring system with highest compromisation to quality control of biologics products to a direction of improving efficiency while advocating process automation are the keys to quicker market commercialization and regulatory compliance. Topics built around cost and process optimization with latest developments in analytics and quality to foster biologics enhancement.
Facility Design, Tech-Transfer & Scale-Up Strategy
Understand the challenges and the trends of biomanufacturing facility design in detail and find out the best practices of formulation and bulk technology transfer for optimizing output while maintaining quality and activity of products. Emphasis on scaling up processes without compromising product quality while discussing the latest technology and solution to scale up for maximum output.
Emerging Technologies and Applications
Identify the most imminent trends on the emerging technologies and applications with the potential to enhance and fasten the biologics manufacturing process. Applications such as PAT tools, novel technologies in single-use technologies and continuous processing, as well as automation and bioprocessing 4.0 to fasten the biologics manufacturing process will be discussed.
2023 #BMA Sponsors & Exhibitors
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Past Supporting Partners
The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organization, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry.
For ongoing news, visit www.a-star.edu.sg.
Cold Chain Platform (CCP) is 100% focused on cold chain and logistics in the biopharmaceutical, life science, and healthcare industries. CCP services help global companies reach the right partners and get a firm foothold in the Asia Pacific. CCP works with global organizations to help them gain access to the APAC cold chain, logistics, and pharmaceutical market through a highly targeted audience.
BioPharma Asia aims to keep its readers abreast of all developments in the areas of Manufacturing, Development, Quality Assurance, Outsourcing, and Regulatory Affairs, with only the highest quality articles and webinars written and presented by the most respected authors/presenters, associated with only end-user companies. This ensures that the information will always be guaranteed to remain timely, informative and above all totally unbiased.
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