Taipei BioProcessing Technology Seminar 28 October 2013

Please join us for this invitation-only event to learn about the latest advances in cell culture and bioprocessing.

Taipei BioProcessing Technology Seminar 28 October 2013

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Regent Taipei Hotel – Taipei, Taiwan

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Situated in the Zhong Shan district, at the heart of the capital’s most vibrant cultural, entertainment and shopping areas, Regent Taipei is a 5 star hotel in Taipei that offers travelers a bird’s eye view of modern Taiwanese life from a highly-convenient vantage point. Easily accessible from the Taipei Song Shan Airport and close to local hot spots such as art museums and historic buildings, Regent Taipei is the only hotel in Taiwan to house in excess of 50 of the world’s luxury designer boutiques in its Regent Galleria shopping mall. Wired and wireless connectivity is available throughout the hotel.*

Address:
No. 3, LN. 39, Sec. 2 ZhongShan N. Rd.,
Taipei 104, Taiwan

Reservations:
Phone: +886-2-2523-8000
E-mail
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Directions: The Regent Taipei hotel is easily accessible via the Taipei main railway station, this centrally located hotel is near Zhong Shan MRT station Exit 4 (MRT Danshui line), which is just five minute’s walk away, Chang Kai Shek International Airport is 45 minutes by car.

Take the Zhong Shan Expressway to the Chong Qing North Road interchange, turn left at Min Zu East Road, continue straight and turn right on Lin Sen North Road to reach the hotel.

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Speakers and Abstracts

Speaker:
Sonjoy Mukerjee, PhD
Associate Technical Director
Thermo Fisher Scientific Asia-Pacific

Topic:
HyCell CHO medium: Targeted for high cell density and productivity across a broad variety of CHO clones

Abstract:
The clonal variation observed in various bioproduction CHO clones has increased demands for a versatile high performing cell culture medium. The Thermo Scientific™ Metabolic Pathway Design™ process and design of experiments approach to design were utilized to develop Thermo Scientific™ HyCell™ CHO medium – optimized for use with a majority of the CHO clones in use today. High-throughput screening allowed for inclusion of individual cell lines, increased component factor-levels and mixture design treatments, and a higher number of replicates. Developmental work was performed at the 96-deepwell scale with subsequent scale-up and comparison of promising treatments at shake flask and bioreactor levels. The results of the study and comparative data will be presented.

Biography:
Dr. Sonjoy Mukerjee is an Associate Technical Director at Cell Culture and BioProcessing, a business unit of the Biosciences division at Thermo Fisher Scientific. Dr. Mukerjee is responsible for media, sera and single use systems in Asia Pacific. He has been in this position for the past 3 years and is responsible for all technical services for Thermo Fisher BPP in the region. He is well known in the area of Humoral Immunology and has close to 25 years of experience in monoclonal antibody development, mammalian gene expression, tissue culture, cell line development and engineering, media and process development.

Prior to joining Thermo Fisher, he was Head of R&D and Global Programs for Life Technologies India. During his 3 year tenure with Life, he was responsible for identifying and executing global R&D projects and leveraging scientific and delivery capabilities for India. This has lead to a $4.5M in funding into India R&D in 2009. Prior to Life Technologies, he was Head of MAB’s and Viral Vaccine team of Shantha Biotechnics (Sanofi Aventis), where he worked for 8 years during which time his team developed and launched several recombinant protein therapeutic products including Erythropoietin in 2005. Prior to Shantha Biotechnics, he has worked for over 10 years in several US Biotech companies such as Novopharm Biotech Inc and Cancer Immuno Biology Labs. Sonjoy has published over 36 international journal papers, and has three US patents to his credit.

Speaker:
Tariq Haq
Senior Global Product Manager
Thermo Fisher Scientific

Topic:
Cell culture media and process optimization approaches for optimal biotherapeutic production

Abstract:
Unique bioprocess requirements of production clones make it necessary to optimize the media and process in order to obtain the most optimal bioproduction. It is vital to quickly assess and meet the specific needs of bioproduction cell culture processes to satisfy the demands of product yield and quality. A media optimization approach that has the ability to thoroughly evaluate the nutrient demands of cell culture from high-throughput format to bioreactor scale, take into consideration potential key component toxicities, provide necessary process specific supplementation and many other critical factors is necessary to come up with media and feed formulations that provide solutions specific to the application. DoE factorial strategy along with our Metabolic Pathway Design approach has been successfully applied to achieve media and feed optimization. High-throughput screening (HTS) equipment facilitated the development and testing of the media formulations. Development and comparative analysis was performed in 96-deepwell plates with subsequent scale-up and comparison of promising formulations in shake flasks and bioreactor studies. Results revealed exceptionally similar trends in both cell density and product quantity, validating the HTS plate design and Metabolic Pathway Design approach. This strategy has been successfully utilized to develop clone specific media formulations and innovative high performing standard products such as HyCell CHO medium. In addition, an optimal supplementation strategy utilizing Cell Boost feeds can further enhance the productivity of a fed-batch process. Case studies will discuss specific media optimization work and results for HyCell CHO and Cell Boost feeds.

Biography:
Tariq Haq is a Senior Global Product Manager at Cell Culture and BioProcessing , a business unit of the Biosciences division at Thermo Fisher Scientific. Tariq is responsible for the entire media product portfolio and has over 15 years of experience in the bioprocess and biotechnology industry. His expertise includes bioprocess production, vaccines, antibodies, transgenics, biosensors, cell culture media and therapeutic development. He has authored scientific publications and chapters in peer-reviewed journals and publications such and Science and Vaccine. Tariq holds degrees in Biotechnology and Biochemistry.

Speaker:
Surendra Balekai
Technical Manager, South East Asia, Taiwan, Australia and New Zealand
Thermo Fisher Scientific

Topic:
Discussion and demonstration of Thermo Scientific's newest products and technologies including the Single-Use Bioreactor and HyPerforma Single-Use Mixer DS 300

Abstract:
Innovations in single-use technologies continue to drive process improvements in biomanufacturing. These improvements are fueling significant cost savings and productivity gains in the manufacturing of vaccines, biologics, and biosimilars throughout the world. The innovation in single-use technologies has been at Thermo Scientific’s core with the recent introduction of Thermo Scientific HyPerforma™ Single-Use Bioreactor and the Thermo Scientific HyPerforma™ Single-Use Mixer DS 300.

The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor is the market leading bioreactor in stirred tank design. We have hundreds of installed systems worldwide used to grow numerous cell lines in a variety of processes. The bioreactor consists of a stainless steel outer container and a single-use bag assembly. The system can be ordered in an open architecture format or as a turnkey solution. The open architecture design allows customers to integrate with any control platform on the market, plug-and-play through standard disposable connectors, avoid the costs of investing in additional control systems, and offers customers the flexibility to choose the control platform they want.

The Thermo Scientific HyPerforma Single-Use Mixer DS 300 provides enhanced mobility, interoperability, and modularity previously unavailable from mixing solutions. It can dock into multiple mixing barrels in 50, 100, 200 and 300L sizes. Single-use bioprocessing container bags were designed for each drum size. It is designed to efficiently mix powder-to-liquid or liquid-to-liquid solutions at different volumes for a wide variety of bioprocess applications including hydration of powdered media and buffers, sterile mixing of buffer solutions, cell culture media with sera and reagents or other process fluids, and pooling of sterile liquid fractions.

This presentation reviews the technological differences between the turnkey and the open architecture platforms and the technological advances of the new Single-Use Mixer DS 300 along with key features and benefits.

Biography:
Surendra Balekai has been involved in supporting customers for process development of vaccines, blood products and recombinant proteins for over 16 years. A graduate in Chemical Engineering, he has been instrumental in designing various equipments for purification of biologics. He has managed engineering and implementation of filtration and purification systems, turnkey projects for the production of microbial/cell culture derived products and blood products.

Surendra served Biotech industry in India by being a part of Millipore for 5 years and Sartorius Stedium for 8 years before joining Thermo Fisher in 2008. Currently, he is heading commercial responsibilities for cell culture products for South East Asia, Taiwan and Australia/New Zealand.

Speaker:
Frank Ho, PhD
Vice President
EirGenix

Topic:
Planning for transformation to a hybrid manufacturing facility

Biography:
Dr. Frank Ho, a PhD graduate from UC Davis, has been working in the biotechnology industry since 1992 after spending 10 years in the academia. His industry experience has been in the areas of bioprocess development, process transfer, manufacturing and contract manufacturing at several biotech companies in the San Francisco Bay Area, including Chiron, Fibrogen, Applied Biosystems, Raven, BioMarin and most recently in Asia worked with PharmaEssentia in Taipei and A-Bio in Singapore.

He has extensive experience in managing cross-functional and cross-cultural teams, and bridging scientific and operational teams to achieve project goals. He has accomplished 10 US FDA-approved biologics through development, and has led and transferred internally more than 40 biologics from development to GMP manufacturing, and has externally led several international contract manufacturing campaigns in Europe, North America and Asia. He has held positions in responsible for manufacturing facility/engineering design, start-up and operation. He is well versed in qualification for large scale fermentor, bioreactor, recovery equipment, disposable system and chromatography skid for manufacturing

Speaker:
Yung-Chih Hu, PhD
Assistant Investigator
National Health Research Institutes

Topic:
The application of single-use bioreactor for cell-based influenza vaccine production

Biography:
Dr. Yung-Chih Hu has more than 10 years of experience in the bioprocess technology development, including animal cell culture process technology using CHO, MDCK and Vero cell-lines, and experience in large-scale, high-cell-density fermentation technology, and downstream purification processes technology. Extensive background in bioreactor design, process controls, equipment validation, facility design and planning. He also has hands-on knowledge of cGMP requirements (FDA/WHO guidelines) and compliance regulations for biological products. Currently, Dr. Hu is an assistant investigator and also a program leader for the development of Influenza vaccines in the National Institute of Infectious Diseases and Vaccinology. In this position, he is leading a team of technicians and research assistants for the development of an Influenza H5N1 vaccine production process using his newly developed cell culture technology - a high cell-yield and animal-component-free culture media. In addition, Dr. Hu involved with technology support and development of disposable bioreactor systems for other vaccine projects. In the past few years, Dr. Hu has successfully completed a number of projects with the Taiwan government agencies, as well as external biopharmaceutical companies. With these on job training, Dr. Hu is able to acquire in-depth knowledge and skill in different part of the bioprocess and eventually developed a broad skill set for the biologics manufacturing.

Speaker:
Karen Wen, PhD
President
Mycenax Biotech

Topic:
Development strategy of Mycenax: Scalable biomanufacturing platforms

Biography:
Dr. Karen Wen currently serves as the President of Mycenax Biotech Inc and she is one of the founders of this company. She has 20 years of experience in the biopharmaceutical industry and is well versed in drug development. Prior to founding Mycenax, she worked at Development Center for Biotechnology in Taiwan as a research fellow, project leader of biomedical plan and manager of research and development for biodevice pilot plant. Her work experience included cell line evaluation, manufacturing process development, clinical trial design, quality assurance and regulatory compliance. Throughout the ten years, she has successfully led her team to execute two biopharmaceutical programs from bench into clinical stage. In the future, Mycenax will carry on 3~5 biosimilars and more new drugs to the market.

Speaker:
Juine-Ruey Chen, PhD
Head of Research & Development
Adimmune Corporation

Topic:
The development of EV71 inactivated virus vaccine with HyClone 50L single use bioreactor

Biography:
Dr. Chen received his Ph.D degree from National Yang-Ming University in Taipei, Taiwan, 2010. Dr. Chen started his vaccine research work since 2005, through the past 8 years of his strong training, he learned not only excellent skills in producing recombinant HA protein as influenza vaccine, but also good technology for the evaluation of vaccine efficacy in mice and ferrets. In 2012, Dr. Chen has been recruited by Adimmune Corp. as a research leader to take the charge of the R&D department. His current work is committed to lead research groups in developing the effective vaccines against pandemic influenza virus. His expertise is glycoprotein purification and cell-based vaccine productions, in particular, to study how glycans on Hemagglutinin affect the immune response and develop the large scale single-use bioreactor for the production of the EV71 and JEV vaccines. His research team has successfully gained the grant and made the progress with a scale of 50 liters single-use bioreactor for preclinical studies. In 2014, his major work is going to extend the production scale to 200 liters to fit within the vaccine quantity demand.

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