The 9th Annual Biologics Manufacturing Asia 2022 is Asia’s the only bioprocessing focused, knowledge sharing conference that provides regional bioprocessing stakeholders a carefully tailored networking platform for leveraging opportunities for strategic collaboration, and exposure to the latest manufacturing technologies and know how. We have the co-located 6th Annual Biologistics World Asia conference and the Asia-Pacific Bioprocessing Excellence Awards as well.
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.
- 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
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
- 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
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.
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.
Sung Ho Hahm
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.
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.
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.
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.
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).
Dr Chi-Tang Tu
Dr Chi-Tang Tu is specialized in stem cells, mitochondria, CIK and NK cells CMC-related activities, including development and manufacturing of drug substance, drug product, new chemically defined stem cell culturing and conditioned medium, to support preclinical development through supplies for clinical phases. Many years' experience of managing and establishing GTP and PIC/S GMP facilities compliance with GLP, GTP and PIC/S GMP. Furthermore, he led an intensive R&D team in development of isolation, scale-up, and cryopreservation process of mitochondria products (biologics) for augment therapy of neurodegenerative diseases and age-related infertility. They built an innovative mitochondria functional analysis platform to assess cell drugs quality and to apply in blood BHI (bioenergetic health index) assay for preventive medicine.
At company, he also supports business and strategy development, patent deployment, engagement and negotiation with venture capital or clients, and in charge of translating the RD works from bench to bedside to business.
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 9th Annual Biologics Manufacturing World Asia is the largest and the ONLY bioprocess business and technology convention in Asia Pacific! In 2022, 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.
Biologistics World Asia
Ultimate focus on the supply chain and logistics of biopharmaceuticals products to achieve the goal of increasing distribution, network and overcoming challenges. Discussion of key factors in biologistic including procurement, warehousing, regulatory affairs, parameters control system and many more. Moving towards the future of biologistics by rethinking the global supply chain of biotechnology.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.
The drug research and development process is highly complex, yet essential for delivering safe and effective therapies to patients. Even though the process is well defined, drug development programs are fundamentally different for each product.
GenScript is a global biotechnology group. GenScript’s businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, as well as cell therapy.
Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions around the world have used GenScript’s premier, convenient, and reliable products and services.
GenScript currently has more than 3000 employees globally, 33% of whom hold master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis and bioinformatics, including more than 70 patents and over 200 patent applications. As of January 2019, GenScript's products and services have been cited by 36,500 scientific papers worldwide.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
For more information, visit www.genscript.com
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $32 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com.
Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics as well as in innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release.
Honeywell’s advanced automation and process controls help Life Sciences manufacturers maintain auditability and traceability, optimize production, and increase speed to market while focusing on quality and repeatability. Data capture, recording and reporting solutions simplify and safeguard cGMP compliance. Fast track your production with flexible and scalable systems, insight into upcoming events or delays, easy troubleshooting, remote asset management, and embedded cyber security.
For more information, visit: www.honeywellprocess.
Comecer, an ATS company, is a developer and manufacturer of high-tech systems in the field of Aseptic Processing and Containment for Pharmaceutical Industries. It designs and manufactures customized isolation technology equipment for pharmaceutical, biotech and chemical applications.
Its containment solutions range from isolators that handle highly active principles or excipients to multi-stage isolators for chemical synthesis or laboratory operations. Its asepsis offerings include isolators designed for sterility tests and formulation of sterile drugs, isolators or RABs integrated into filling lines, and dedicated solutions for Regenerative Medicine applications, including the innovative FlexyCult incubation system for Advanced Therapy labs. Let Comecer show you how we are bringing down the cost of producing ATMPs.
Comecer products are known and used in hospitals, universities, research centers, pharmaceutical companies, cell factories and large industrial groups worldwide.
More information can be found at www.comecer.com/fields/atmp/
Boehringer Ingelheim BioXcellence TM is a one of the leading biopharmaceutical contract manufacturers in the world. As a pioneer in biomedical technology, Boehringer Ingelheim started the research and production of biologics in the 1960s with our ground-breaking work on interferons. Since then, we have successfully delivered 39 biopharmaceuticals to the global market, bringing better health to more patients. As the industry leader, Boehringer Ingelheim have partnered with diverse global players, including Top 20 pharma giants, biotech companies, and start-ups. Now Boehringer Ingelheim brought its 30 years-plus of experience into China to establish the biopharmaceutical manufacturing service at global standard. We are committed to supply world-class quality biopharmaceuticals to the global market via our facility in Shanghai, China.
More information please visit：http://www.bioxcellence.com/
Founded in 2001, Mycenax Biotech Inc. (MBI) is a CDMO company offering integrated services for the development and manufacturing of biologic products, including cell line generation, process, formulation, and analytical method developments, GMP production for both mammalian and microbial systems, and fill-finish for both liquid and lyophilized forms.
MBI has extensive experience in developing biologic products for our clients around the globe. Ranging from small peptides, fusion proteins, and monoclonal antibodies, to cell therapy products, we provide our clients with time- and cost-effective services through our high-standard technology platforms and PIC/S GMP certified manufacturing facility. For the cell line development, we recently introduced the Beacon® Optofluidic System (Berkeley Lights, US) to streamline the workflow and provide strong evidence for monoclonality. For process development, we are pioneered in developing continuous bioprocess. For GMP manufacturing, our 2 nd GMP facility, which hosts 2 production lines with up to six 2,000L bioreactors will be completed in mid-2021 to further expand our GMP production capacity.
With our innovative technology and qualified GMP facilities, we are the best partner for clients worldwide for developing biologic products at all developmental stages.
For more information, please visit our booth or website at: http://www.mycenax.com.tw/en
Kemwell is a leading biologics CDMO in Asia which provides services to global biopharmaceutical organizations. Kemwell, having established in 1980, has had long-term associations with pharma majors for small molecule CDMO. In 2016, Kemwell divested its small-molecule global business to Recipharm with an aim to focus on biologics CDMO business. The facilities in Bangalore, India consists of a cGMP drug substance manufacturing suite with over 4000L bioreactor capacity in operation, a sterile fill and finish suite for cGMP drug product manufacturing and process development laboratories to support production of protein therapeutics using mammalian expression systems – mAbs, bi-specifics, fusion proteins, etc. Kemwell is capable of supporting novel, bio-better and biosimilar program’s preclinical development, clinical development, cGMP clinical and commercial manufacturing.
- - Process development capabilities: AMBR250, 5L, 10L and 80L scale bioreactors.
- - cGMP Drug substance: 80, 400 and 2x2000 L train. Expansion plan for additional 12 KL reactor capacity in an existing shell place of 26,000 sq. ft.
- - cGMP Drug product: Liquid and lyophilized vials, sizes from 2 - 50 ml.
- - Successfully manufactured Phase III clinical campaign for US trials also several clinical campaigns for EU and APAC trials.
- - Commercial manufacturing – One globally approved DS for APAC region with annual commitment of 30 batches at 2000 L scale. Two DPs for APAC market, one each liquid and lyophilised vial. Around 60 batches per annum commitment.
- - cGMP ‘Cell Therapy’ manufacturing facility to be operational by Q2 2021.
For more information, visit http://www.kemwellbiopharma.com/
G-CON Manufacturing designs, builds and installs prefabricated cleanrooms. G-CON’s POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD cleanrooms surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing once the production process reaches its lifecycle end.
For more information, visit: www.gconbio.com
For more information, please visit: MerckMillipore.com/BioContinuum
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development, and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.
Present your expertise to the Asian Bioprocessing industry’s key stakeholders through a variety of available speaking packages.
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