The Aseptic Fill-Finish and Packaging Conference 2023 is the Asia Pacific region’s only fill-finish and packaging focused conference. This event links the biologics industry leaders in fill-finish, drug formulation, aseptic processing, packaging innovations from BIG Pharma, Biopharma, Biologics and Vaccines Manufacturers to update on the latest technologies in fill-finish operations, best practices of biologics formulation, next generation packaging solutions and digitalization with considerations of GMP regulations. Debate on the best practices of fill-finish and packaging practices, sharing intelligence and network with the industry leaders around the globe. The Aseptic Fill-Finish and Packaging Conference 2023 makes its impact in a hybrid format, combining an in-person conference experience with a virtual component.
Asia-Pacific accounts for the largest share of the global fill-finish manufacturing market during the forecast period. It is expected to be the fastest-growing segment during the forecast period. Factors such as increasing investments by CMOs & key biopharmaceutical players in Asian countries, increasing government support, developments in R&D infrastructure, and growing expertise & academic excellence in the APAC region are driving the market growth.
Along with the Asia Biologics Festival, the AFFP 2023 is co-located with 10th Biologics Manufacturing Asia 2023, 7th Annual Biologistics World Asia conference, and the iconic in-person Asia-Pacific Bioprocessing Excellence Awards 2023.
Shawn Shouye Wang, Ph.D.
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.
Zorica Dragic Arunasalam
MD Atiqur Rahman
Won Min Kim
Feng Lin Wang
Yang Yuan Sheng
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.
Bharat Bhushan Rathi
Bharat is a highly accomplished professional who has worked across different industries. With Key expertise in aligning corporate and global programs with regional and local functions. He has an exceptional success record of 14 + years spanning across roles involving Inbound/Outbound logistics Operations, Distribution, Warehouse Designing & management, Vendor Management, Purchase/ Procurement, Planning. Developed skills in successfully identifying and implementing innovative practices which lead to major cost savings besides optimizing the Supply Chain.
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
Sang Min Lee
- 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
- 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
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.
A/Prof. Bi Xuezhi
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 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.
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).
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.
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.
The fill-finish services market expects to grow at a CAGR of approx. 13% during 2020-2026. Fill-finish services are subject to extreme scrutiny by regulatory agencies and tend to be costly in the manufacturing process. Hence, biopharmaceutical companies tend to outsource fill-and-finish needs to gain access to specialized technology, meet unexpected demands, source policies or better matching scales. CMOs are extremely helpful in meeting balanced production volumes and commercial validation of manufactured products. The growth in biopharmaceuticals is likely to fuel the demand for fill-and-finish contract services.
Asia-Pacific accounts for the largest share of the global fill-finish manufacturing market during the forecast period. It is expected to be the fastest-growing segment during the forecast period.
Asia Pacific also represents the fastest growing market for temperature-controlled packaging essential in biologics transportation. The complexity of biological-based medicines mandates similarly complex and involved cold chain and packaging requirements. Increasing demand for vaccines and cell and gene therapies will power a surge in demand for such packaging. With trends towards automation, sustainability, reusability and a wholesale re-thinking of the supply chain in the wake of COVID-19, biopharma supply chain and quality management teams in charge of packaging will face both challenges and opportunities。
Factors such as increasing investments by CMOs & key biopharmaceutical players in Asian countries, increasing government support, developments in R&D infrastructure, and growing expertise & academic excellence in the APAC region are driving the market growth. VPs, Director and Heads of Fill-Finish manufacturing and Packaging experts will come together to discuss the best practices, latest technologies and solutions to address the key challenges moving forward the APAC region's fill-finish and packaging industry.
Fill-Finish Innovation to Streamline Operations
Discover the latest fill-finish innovations and emerging technologies with the utmost importance of incorporating the technologies into streamline operations for reduced timeline of production while maintaining outstanding quality of biologics and vaccine products.
Parenteral Drug Formulation & Lyophilization
Understand the challenges of pre-formulation, bulk formulation technology, analytical testing, cycle development and optimization while exploring the best practices of drug formulation and lyophilization for highest product stability and activity.
Advanced Aseptic Processing Techniques
Get insights on the processing and packaging of a commercially sterile product with the ultimate purpose of keeping the sterile products safe and free of contamination. Immerse in the advanced next generation aseptic processing facility design and engineering to ensure longer product shelf life and optimized biologics product quality.
Best Practices of Quality Assurance, Checking and Inspection of Lyophilized Vials
Innovation strategy to quality inspections of finished products for quicker market commercialization and regulatory compliance. Get exposure to both visual and manual inspection and debate on the best practices of quality assurance and checking of biologics products with highest quality standards.
Packaging, Labelling and Assembly
Immerse in up-to-date packaging, labelling and assembly insights including automation, dealing with potential fill and finish shortfalls, exploring diversification with RTU (Ready-to-Use) vials and moulded glass and more.
Packaging Digitalisation and Automation
Discover tracking and monitoring potential for efficient and high-visibility packaging, traceability and sustainability methods that can be unlocked for high-value biologics shipments via data usage and digitalisation.
QA and Compliance
Unpack safety and compliance precautions for temperature-sensitive products, ensure improvement at reusing and recycling packaging items from plastics, polymers, paper, glass and metals while maintaining sterility for elements like parenteral containers, viles and oral dispensers.
Increase Cold Chain Speed and Efficiency
Discover how to choose the right containers and packaging designs to maintain thermal performance, and identify resilient phase-change materials for long and complicated routes through various jurisdictions and the crucial last mile.
MasterControl Inc. is the leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner.
You can use the MasterControl Product Lifecycle Excellence™ platform to digitize, automate and connect quality and compliance processes at every step – from concept to commercialization. Join over 1,000 companies worldwide that rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance.
Learn more at www.mastercontrol.com
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
Merck, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. Our products and services help you safely and efficiently develop and manufacture therapeutics.
Our BioReliance® Biosafety Testing Services offer comprehensive and integrated services that support every phase of the testing, development and manufacturing process.
Your Therapy, Our Priority
Visit our Merck booth.
Speak to us, and learn more:
Science and Lab Solutions (SLS) provides a more seamless experience to customers as they continue to benefit from our scientific expertise and access to one of the broadest portfolios in the industry.
Pall Corporation provides critical filtration, separation, and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe. Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers' biggest fluid management challenges. And in doing so advance health, safety, and environmentally responsible technologies. Together, our Life Sciences and Industrial teams serve a diverse range of customers including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive and power generation industries. Our industry-leading technologies and solutions are at work in countless applications, protecting critical operating assets, improving product quality, safeguarding the health, and minimizing emissions and waste
For more info, please check: https://www.pall.com/en/biotech.html
Cytiva is a global life sciences leader with more than 8,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture, and delivery of transformative medicines to patients.
Gamma Biosciences is a leading life sciences company providing products and services to support the development and manufacturing of advanced biologic therapies. Our operating companies are committed to advancing the science and art of bioprocessing by delivering market-ready innovation and expertise that helps our customers, mainly biopharmaceutical companies and contract development and manufacturing companies, safely bring therapies to patients more quickly and efficiently. Gamma is a global company with offices and major manufacturing facilities in North America, the U.K. and Belgium.
With more than 130 years of experience, Dr. Paul Lohmann® is a German expert in salt manufacturing and provides DPL-BioPharm Salts for the biopharmaceutical industry. These salts act as nutrients for cell cultures, as buffering and post-harvest processing agents within upstream processing. For downstream processing various acetates, citrates, phosphates and sulfates enable efficient bioprocesses for separation, precipitation and purification.
Datwyler is a leading industrial supplier and a key player in the global health care world.
Our state-of-the-art solutions for drug packaging and medical devices, build on over 100 years of experience. Within our healthcare offering, we provide a unique range of products and services including the most advanced elastomer formulations, coatings, aluminum
seals, and processing technologies. Partnering up with the world’s top pharmaceutical and medical companies, we are a vital link and stand by our mission to ensure all patient’s safety and improve patients’ lives.
For more infromation, please visit: https://datwyler.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
Present your expertise to the Asian Bioprocessing industry’s key stakeholders through a variety of available speaking packages.
Join the exhibition, and build an impressive presence among your potential clients.
Emphasize on your messages by promoting your brand alongside exhibition and thought leadership.
Engage with and build lasting connections that matter the most to your business.
Gain exclusive access to contacts of high-profile attendees through intimate networking opportunities.