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Facilitating Development & Manufacturing of High Quality Biologic Drugs & Vaccines in Korea for the World Market 29 – 30 June 2016
Seoul, Korea
Conference Proceedings
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
CONTENTS The IMAPAC Difference
Section 1
Welcome IMAPAC, Imagine Your Impact Speed Networking Our Media Partners Outside of Conference Hours
Conference Programme Day 1
Section 2
Conference Programme Day 2
Section 3
Conference Evaluation
Green Form
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
IMAPAC welcomes you to BIOLOGICS WORLD KOREA 2016 Jonathan Whelan General Manager Tel: +65 3109 0123 Email: jhonatan.whelan@imapac.com Sumukhi SREEVATSAN Conference Manager Tel: +65 3109 0126 Email: sumukhi.sreevatsan@imapac.com YEO Siang Yee Conference Manager Tel: +65 3109 0127 Email: siangyee.yeo@imapac.com Ana LAXAMANA Regional Business Development Director Tel: +65 3109 0128 Email: ana.laxamana@imapac.com Asher VILLEZA Delegate Sales Executive Tel: +65 3109 0155 Email: asher.villeza@imapac.com Rosa MEDINA Delegate Sales Executive Tel: +65 31090130 Email: rosa.medina@imapac.com Cecilia WONG Operations Manager Tel: +65 8168 5788 Email: cecilia.l.wong@imapac.com Angelica CELIS Marketing and Operations Manager Tel: +65 3109 0122 ext. 110 Email: angelica.celis@imapac.com
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
About IMAPAC - Creating Conferences with A Cause IMAPAC is a social enterprise that is on an unrelenting mission to strive and make a difference to businesses of today. We believe businesses are not only meant to do well, but also to do good. We want you to find business opportunities at our conferences as well something good to aim for. IMAPAC’s conferences are when you join other organizations such as governments, NGOs, businesses, academics and other stakeholders who standing up collectively to make a difference, to attest to the fact that businesses can and do make a positive impact to the world we are living in.
Just Imagine your Impact When you speak at an IMAPAC conference, not only does the industry hear you, the world does too – via IMAPAC TV broadcast FREE to everyone around the globe. When participate at an IMAPAC conference, not only does your knowledge and contact book get extended, a child from a developing country gets to go to school for year.
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BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Speed Networking @ IMAPAC - Creating Conferences with A Cause We have an exciting networking activity planned for you during the conference. Here’s how the IMAPAC speed networking session works: 1.
When you enter the networking area, make your way to any one of the bistro tables. Each table should be made up of a maximum of 8 - 10 people.
2.
You should have already picked up an envelope earlier during registration. Your envelope contains either a Blue or Green card. * Please request at the registration should you not receive it.
3.
At the sound of the bell, your networking time with others at your current table begins. You will have about 4-5 minutes.
4.
Then, at the sound of the second bell, and all subsequent bells, you should move to the next table* and begin your networking with the new group of people. * All delegates with blue cards move clockwise, and all delegates with green cards move anticlockwise. Directions will also be indicated on the tables. 5. The networking session will finish when you are back with your original group. TIP: Use your envelope to collect business cards of your new acquaintances!
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BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Our Supporting Associations
Our Media Partners
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Outside Conference S Hours
eoul has been the capital of Korea for about 600 years, since the time of the Joseon Dynasty (1392-1910). Seoul was referred to as "Han Yang" during the Joseon Dynasty. The newly founded Republic of Korea officially changed its capital city's name to Seoul. Seoul has developed into a bustling metropolis, acting as the hub for political, economic, social, and cultural matters.
GYEONGBOKGUNG PALACE arguably the most beautiful and remains the grandest of all five palaces is also called “Northern Palace” because it is the furthest north when compared to the neighboring palaces of Changdeokgung (Eastern Palace) and Gyeongheegung (Western Palace). The name of the palace, Gyeongbokgung, translates in English as “Palace of Shining Happiness.” The premises were destroyed by fire at the time of Japanese occupation from 1592-1598. However, all of the palace’s 7,700 rooms were later restored under the leadership of Heungseondaewongun during the reign of King Gojong. The National Palace Museum of Korea is located south of Heungnyemun Gate, and the National Folk Museum is located east within Hyangwonjeong.
It is all about fashion, fashion & fashion in MYEONGDONG, Seoul’s primary & most famous shopping district. If it’s variety that you’re after, there’s no better place to shop than Myeong-dong where you’ll find everything from internationally-recognized name brands to unique items. Myeongdong also houses a variety of family restaurants, fast food, plus Korean, Western and Japanese dining options. Many restaurants in Myeongdong specialize in pork cutlet (donkas) and kalguksu (thick noodles).
Not to forget, Myeongdong is the place where everyone shops for famous Korean Cosmetic brands such as Etude House, Skin Food, Laneige, The Face Shop, Missha!
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
N SEOUL TOWER located on Mt. Namsan offers great panoramic views of the city, and has been a symbol of Seoul since it first opened to the public in 1980. Not only the tower was recently undergone a major remodeling, but also a new name following a complete makeover. It is now a true cultural space with various performances, movies, exhibitions as well as upscale restaurants and snack bars.
DONGDAEMUN is Korea’s largest wholesale and retail shopping district has 26 shopping malls, 30,000 specialty shops, and 50,000 manufacturers. Opening from 10:30 a.m. to 5:00 a.m. except Monday & some public holidays, you can literally shop all night! The fabric and clothing here are of the latest fashion trends in the world. Inventory is imported and exported in real time, making Dongdaemun a must-visit for fashion enthusiastic.
CHEONGWADAE is the executive office and official residence of the President of the Republic of Korea. The Korean name literally translates to “pavilion of blue tiles.” The signature markings of the Presidential Residence of Cheong Wa Dae are its blue tiles. It is the first thing that catched one’s attention upon entering the premises. The blue tiles and the smooth roof blend beautifully with Mt. Bugaksan in the backdrop. The unique buildings Cheong Wa Dae are comprised of the Main Office, Yeongbingwan (Guest House), Chunchugwan (Spring and Autumn Pavilion), Nokjiwon (Green grass), the Mugunghwa (Rose of Sharon) Valley, and the Seven Palaces. There is also a weekly Military Drill Demonstration & Parade by the honor guards every Saturday 10am.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Situated between by two palaces, Gyeongbokgung to the west and Changdeokgung to the east, this village has the largest cluster of privately owned traditional Korean wooden homes or hanok in Seoul. The BUKCHON area is a traditional residential area in Seoul that boasts 600 years of history. Its location reflects the views of neoConfucianism, regarding the world and nature, during the Joseon Dynasty. Hanok architecture places great emphasis on the topographical features of the land on which it is built. Structural arrangements, layouts, and other spatial aesthetics are major concerns here, as are the styles of the buildings themselves.
CHANGDEOKGUNG PALACE was the second royal villa built following the construction of Gyeongbukgung Palace in 1405. The buildings have remained largely intact over six centuries and served as a backdrop for the last chapters of the Joseon period (1392-1910). Korea’s last emperor Sunjong passed away on these grounds in 1926, and it’s commonly known that members of royal descendants lived in Nakseonjae, a cluster of unpainted palace buildings well into the late ‘80s. The palace had a great influence on the development of Korean architecture, garden and landscape planning, and related arts, for many centuries. It reflects sophisticated architectural values, harmonized with beautiful surroundings.
One of the most memorable Seoul attractions and represents the focal point of Korean traditional culture and crafts. Stores in INSA-DONG specialize in a wide variety of goods that can only be purchased or appreciated in Korea: hanbok (traditional clothing), hanji (traditional paper), traditional teas, pottery, and folk crafts. There are about 100 galleries in the area and you can see every example of traditional Korean fine art from paintings to sculptures. The teahouses and restaurants are the perfect compliment to the galleries. Every Sunday from 10:00 – 22:00, some streets are blocked off from traffic and it becomes a cultural space. Stores set up booths outside and others set up shop (Korean candy merchants and fortune tellers.) There are traditional performances and exhibits as well.
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02/06/2016 11.50
Conference Day ONE 29 June 2016, Wednesday
Conference Day ONE
CONFERENCE AGENDA Wednesday, June 29, 2016
8:55 a.m. 9:00 a.m.
Exhibits Open
8:50 a.m.
IMAPAC’s Welcome Remarks Yeo Siang Yee, Conference Manager , IMAPAC, Singapore Chairman’s Opening Remarks Keynote: Evolution of Biopharmaceutical Manufacturing For Novel Biologics Uwe Gottschalk, Chief Technology Officer, Lonza, Switzerland
9:25 a.m.
Establishing Robustness and Consistency in Large Scale Biologics Manufacturing Jeong Won Yun, Vice President, Head of Manufacturing, Celltrion, Korea
9:50 a.m.
Addressing the Challenges in the Process Development of Antibody Drug Conjugates Sun Bae Lee, Head of ADC Team, Alteogen, Korea
10:15 a.m.
Strategies and Recent Successes on Best Practices and Efficient Technology Transfer Approaches Kara Calhoun, Senior Group Leader, Global Biologics MSAT, Genentech, USA
10:40 a.m.
Speed Networking and Morning Refreshment
11:10 a.m.
Molecular Bioprocess with Convergence Engineering Platform Jung Wook Hong, Professor, Bionano Engineering and Bionano Technology, Hanyang University, Korea
11:35 a.m.
Case Study: Cell Line Development to Produce a Novel Bispecific Antibody Targeting Dual Antigens Weon-Kyoo You, Head of R&D, ABL Bio Inc., ABL Bio Inc., Korea
12:00 p.m.
Case Study: Structure-based Glycoengineered VEGF-Grab, with Enhanced Pharmacokinetic Profile and Anti-Angiogenic Efficacy Jung Eun Lee, Assistant Researcher, K-Bio; Osong Medical Innovation Foundation, Korea
12:25 p.m.
Networking Luncheon
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Workshop with TERUMO: Polymer Based Prefillable Syringes Designed to Minimize the Aggregation Risk of Sensitive Biodrugs Katsuyuki Takeuchi, Manager of Business Development, Global Pharmaceutical Solutions, Terumo Corporation, Japan 1 : 2 5 p. m .
Increasing Efficiency through IVCC Approach for Mammalian Cell Culture Automation & Kinetics Yung Shyeng Tsao, Senior Principal Scientist, Merck & Co., USA
1 : 5 0 p. m .
Industry Presentation: Modifying Antibody Protein Quality through Optimization of Cell Culture Media & Supplements’ Matthias Brand, Market Development Manager - Advanced Bioprocessing (Asia), BD Biosciences, Singapore
2 : 1 5 p. m .
Single-Chain Antibody Process Development - Challenges and Solutions Sushil Gupta, Principal Scientist, Syngene International, India
2 : 4 0 p. m .
Overcoming the Challenges in Purification of PEGlyated Proteins Shuichi Yamamoto, Director, Biomedical Engineering Center, Yamaguchi University, Japan
3 : 0 5 p. m .
New Advances in Protein Purification Methods For Scale-Up of Downstream Processes Neha Kothari, Associate Research Scientist, International Vaccine Institute, Korea
3 : 3 0 p. m .
Afternoon Refreshment
4 : 0 0 p. m .
New Purification Processes Based on Keystone Contaminant Management Wei Zhang, Research Scientist, Downstream Processing, Bioprocessing Technology Institute, Singapore
4 : 2 5 p. m .
Upgrading Platform Processes for Antibody Manufacturing to Increase Productivity Kunihiko Kodaira, Downstream Process Development, Chugai Pharmaceuticals, Japan
4 : 5 0 p. m .
Batch to Continuous Processing: What Is Holding the Industry Back from Executing Continuous Processing? Steven Lee, Founder & Chief Executive Officer, BioGENEXUS, USA (Moderator) Jeong Won Yun, Vice President, Head of Manufacturing, Celltrion, Korea (Panelist) Scott Liu, President & Chief Executive Officer, Henlius Biopharmaceuticals, USA (Panelist) Shuichi Yamamoto, Director, Biomedical Engineering Center,
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Yamaguchi University, Japan (Panelist) 5 : 4 0 p. m .
Workshop with PALL LIFE SCIENCES: Single-Use, Continuous Bioprocessing: Value Proposition & How to Get Started Rob Noel, Business and New Technologies Development, PALL Life Sciences, UK
6 : 0 0 p. m .
Chairman’s Closing Remarks & Welcome Cocktail
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Keynote: Evolution of Biopharmaceutical Manufacturing For Novel Biologics Uwe Gottschalk, Chief Technology Officer, Lonza, Switzerland Uwe Gottschalk is Chief Technology Officer (CTO) at Lonza Pharma/Biotech since June 2014. Before joining Lonza he served as Group Vice President at Sartorius Stedim Biotech between 2004 and 2014 with a global responsibility for all bioseparation-related process technology. He worked in different capacities for Bayer Health Care from 1991 to 2004, overseeing the process development and manufacturing of biopharmaceutical products such as monoclonal antibodies and other recombinant proteins. He has written extensively in the areas of downstream processing, industrial biotechnology and somatic gene therapy. In academia, Dr. Gottschalk is currently Head Lecturer at the University of Duisburg- Essen (Germany) and also lectured at the Ecole Polytechnique Fédérale de Lausanne (EPFL) in Lausanne (Switzerland).
Current global trends transpiring in the biomanufacturing space Observations on the paradigm shift from hard-piped towards disposable manufacturing New directions in improving economics, flexibility and quality o f biologics, cell therapies, gene therapies and ADCs
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Establishing Robustness and Consistency in Large Scale Biologics Manufacturing Jeong Won Yun, Vice President, Head of Manufacturing, Celltrion, Korea Jeong Won currently serves as Vice-President in Celltrion, leading the Manufacturing Division which is responsible for the cell culture, purification, fill and finish GMP productions, as well as overseeing the facility operations and maintenance of the manufacturing facility. He has over 25 years of industry experience, and has extensive expertise in plant cell culture and animal cell culture process development, upstream & downstream process development, including design & construction of cGMP manufacturing facilities.
What are the key factors for high quality biologics manufacturing? Influence of manufacturing facility on the robustness and consistency of biologics production Product development stage as a starting point for robust manufacturing processes
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Addressing the Challenges in the Process Development of Antibody Drug Conjugates Sun Bae Lee, Head of ADC Team, Alteogen, Korea Sun Bae currently serves as Senior Research Scientist in Alteogen, leading the ADC team, where he specializes in process development of ADCs. Sun Bae obtained his PhD at Seoul National University, before embarking on his academic career, during which he published extensively and presented on many occasions.
Strategies for process development of scalable and robust ADC manufacturing processes, to produce products with desired drug-to-antibody ratio and consistent product quality attribute s Current lack of comprehensive specific regulatory guidance, and the need for heightened analytical testing Critical aspects in ADC process development, and developing robust conjugation processes
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Strategies and Recent Successes on Best Practices and Efficient Technology Transfer Approaches Kara Calhoun, Senior Group Leader, Global Biologics MSAT, Genentech, USA Kara Calhoun is an Associate Director and Principal Engineer in Genentech’s Global Manufacturing Science and Technology organization. In addition to managing a group of cell culture experts, she also is the technical head on the Drug Substance leadership team for External Manufacturing and participates on the Joint Steering Committee with one of Roche’s external manufacturing partners. Kara has over 19 years’ experience in bioprocess technologies, including as a group leader in Late Stage Cell Culture leading process development for PhIII and new commercial process version projects. She served as a Technical Development (CMC) Team Lead for an accelerated development molecule that achieved record-breaking timelines. Previously, she supported live virus vaccine development while working at Merck & Co., Inc. Kara received her undergraduate degree from Princeton University and her Ph.D. from Stanford University, both in Chemical Engineering.
Technology transfer framework that incorporates quality, speed, and risk management Technical aspects of facility fit, scale-up/scale-down, and manufacturing campaign obstacles Special considerations for transfers to external partners
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Molecular Bioprocess with Convergence Engineering Platform Jung Wook Hong, Professor, Bionano Engineering and Bionano Technology, Hanyang University, Korea Dr. Jong Wook Hong is Professor of Bionano Engineering and Bionano Technology at Hanyang University, Korea. He also served as a tenured faculty member in the department of Mechanical Engineering at Auburn University, U.S.A. Hong has intensive experience in engineering and biotechnology fields. He has published research papers in various journals including Science and Nature Biotechnology. He teaches and studies microsystems for convergence bioprocess engineering and future medicine. Hong received his Ph.D. from the University of Tokyo, Japan, in Chemical Engineering and was a postdoctoral scholar at Thomas J. Whatson Laboratories of Applied Physics, the California Institute of Technology (Caltech), Pasadena, U.S.A.
Newly developed tools facilitate developments of bioprocess as well as advancements of pharmacy medicine. Automated convergence systems are examples of recently available platforms that could change molecular bioprocess engineering into another level with accurate, reliable, and cost-effective systems. With automated convergence systems, efficiency of bioprocess for the manufacturing pharmaceuticals and other biological valuable substances is dramatically increased handling single cell-level strains of microbes and animal cells. In this lecture, we introduce engineered micro-, nanofluidic systems for biopharmaceutical and medical application including single cell bioprocessing of bacterial strains, mammalian cells, and ultra-fine characterization of catalytic efficacy tests with the convergence platforms.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Case Study: Cell Line Development to Produce a Novel Bispecific Antibody Targeting Dual Antigens Weon-Kyoo You, Head of R&D, ABL Bio Inc., ABL Bio Inc., Korea Weon-Kyoo You received his PhD majored in Biochemistry at Yonsei University in 2004. Then, he worked as a postdoctoral fellow at UC San Francisco, and as a researcher at Sanford-Burnham Prebys Medical Discovery Institute from 2004 to 2012. He was successfully performed several research projects and published many papers regarding tumor-induced angiogenesis and tumor microenvironments. After he came back to Korea, he was involved in the drug development project to discover and develop a novel bispecific antibody as more efficient anti-angiogenesis agent at Hanwha Chemical, Biologics R&D center. Currently he is working as R&D Head at a new startup biotech company, named as ABL Bio Inc.
Development of a stable cell line with high expression level of a target protein is an important step in the overall development process for therapeutic biological products, biosimilars as well as novel biologics. Before entering the stable cell line development, we successfully generated a novel bispecific antibody targeting dual antigens, vascular endothelial growth factor (VEGF) and Delta-like ligand (Dll4), through early discovery process. The bispecific antibody (ABL001; former HD105) is composed of an anti-VEGF antibody backbone C-terminally linked with a Dll4-targeting single-chain variable fragment, showed similar or better biological activities by using various in vitro and in vivo assays compared to each single antigen targeting monoclonal antibody. It would be more difficult and complicated to develop a stable cell line expressing high level of ABL001 due to the unique structure of the bispecific antibody, which is different with a general antibody structure. In this case study, we present and discuss how we could select a single cell to produce the bispecific antibody, which criteria were critical for developing the research cell bank (RCB) from selected single clone candidates, and what were important points for moving forward to GMP-grade manufacturing of the master cell bank (MCB). In conclusion, we successfully developed the MCB to produce the bispecific antibody (ABL001) with 1 g/L of expression level from a pilot scale (200L) of cultivation process.
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BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Case Study: Structure-based Glycoengineered VEGF-Grab, with Enhanced Pharmacokinetic Profile and Anti-Angiogenic Efficacy Jung Eun Lee, Assistant Researcher, K-Bio; Osong Medical Innovation Foundation, Korea She received PhD in Biological Sciences at Korea Advanced Institute of Science and Technology (KAIST) in 2015. During her PhD course, she received scholarship from Keystone Symposium on Angiogenesis and Lymphangiogenesis in Cancer in 2009. In addition, she awarded a research grant from KAIST, High Risk High Return Project (HRHRP) from 2012 to 2013 for the ‘development of next generation of VEGF blocker’ which is supervised by Prof. Homin Kim. Since 2015, she has worked at New Drug Development Center, Osong Medical Innovation Foundation as an assistant researcher of Cell Line Development Team.
Glycosylation is one of the important post-translational modifications influencing on protein’s characteristics including antibody-dependent cell-cytotoxicity (ADCC), half-life, and stability. Therefore, glycoengineering of therapeutic proteins can be good strategies to enhance their therapeutic efficacy. Aranesp (erythropoietin, Amgen) and Gazyva (obinutuzumab, Genentech) are good examples that exploited advantages of glycosylation. Here, we developed a novel VEGF decoy receptor fusion protein, VEGF-Grab. Parental VEGFR1-Fc (VEGFR1 D2-D3 fused to Fc) was used as a backbone, and new potential glycosylation sites were introduced into the positively charged patch of VEGFR1 D3. This engineered VEGF-Grab showed significantly improved decoy efficiency and a dramatic decrease in net pI thus attenuating nonspecific ECM binding and enhancing PK profiles. Furthermore, VEGF-Grab strongly suppressed tumor angiogenesis, progression, and metastasis via effective capturing of three VEGFR1 ligands, VEGFA, VEGFB, and PlGF.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Workshop with TERUMO: Polymer Based Prefillable Syringes Designed to Minimize the Aggregation Risk of Sensitive Biodrugs Katsuyuki Takeuchi, Manager of Business Development, Global Pharmaceutical Solutions, Terumo Corporation, Japan Katsuyuki Takeuchi is a manager of business development in Global Pharmaceutical Solutions, Terumo Corporation. With extensive knowledge in pharmaceutical science, he has worked in research and development of injectable drug products such as IV bags and prefilled syringes, and contributed to launch several products into the market. Utilizing his experience, he is now working on introducing polymer based prefillable syringes to the pharmaceutical industry.
How to minimize the aggregation risk by choosing the right primary container Design and performance of polymer based prefillable syringes Advantages of a silicon oil-free syringe system Advantages of autoclave sterilization
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS ď€¸ď€ http://www.imapac.com/business_conference/biologics-world-korea-2016/
Increasing Efficiency through IVCC Approach for Mammalian Cell Culture Automation & Kinetics Yung Shyeng Tsao, Senior Principal Scientist, Merck & Co., USA Dr. Tsao received his Ph.D. from the University of Tennessee, specialized in liposome and membrane technologies. He was a postdoctoral fellow in New York University, specialized in membrane trafficking and protein secretion mechanisms. He joined Schering-Plough Research Institute/Merck in 1988 and developed cell lines for gene therapy, recombinant protein production. He has published in the area of protein isolation and characterization, membrane biophysics and fusion mechanisms, liposome drug targeting, membrane trafficking, protein secretion and degradation mechanisms, animal cell culture media, serum-free virus production, aggregated cell monitoring, cell growthprotein productivity-metabolic modeling, cell culture miniaturization and automation, transcriptome and integrative pathway analysis.
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Mammalian cell culture automation relies on timely detection of cultural parameters, such as cell densities, metabolic concentrations as well as waste build-up, and a reliable algorithm for timely intervention to sustain cellular wellbeing and desired productivity. The conventional approach for calculating cell growth and metabolic rates is mostly time-based. However, if cell densities, metabolite concentrations and product titer are plotted against IVCC (Integral of Viable Cell Count) then the slopes would show their specific rates. The IVCC conversion can not only provide direct visual cues for the investigators but is also more accurate than the time-based analysis for specific rate computation since it is not affected by the fluctuations in cell viability during the cell culture batch. In this presentation, we will show how parameters such as glucose, lactate, glutamine and glutamate can be used to determine cell densities, viability, and cell growth rate without counting cells once the correlation for the cell line is established. We will also show that the IVCC approach can demonstrate distinct phase changes for cell growth, death, and product formation which correspond to different metabolic phase changes for 12 individual CHO clones expressing the same therapeutic antibody investigated. In addition, the efficiency of cell making is shown to determine the maximal cell density and the duration of cell culture of the fed-batches. In conclusion, IVCC approach can be a key for cell culture automation which requires simplicity, sensitivity, accuracy, and predictability.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Industry Presentation: Modifying Antibody Protein Quality through Optimization of Cell Culture Media & Supplements’ Matthias Brand, Market Development Manager Advanced Bioprocessing (Asia), BD Biosciences, Singapore Matthias has a BA in Business and after obtaining a PhD in Microbiology from the Albert-Ludwig University, Freiburg, Germany he did a Postdoc at UNSW, Sydney, Australia. For the last 16 years he worked in the Biotechnology/Biopharma field, initially with yeast and microbial expression systems later on cell line-, media- and process development with numerous mammalian expression systems. Since 2010 he is in his current role as Market Development Manager for the Asia Pacific region with BD Advanced Bioprocessing.
For many years, monoclonal antibodies have been used to treat a wide range of diseases. With multi-gram titers becoming increasingly common, focus has shifted to MAB product quality and consistency. Cell culture media and supplements, together with the cell line and manufacturing process, play a vital role in achieving the desired titer and protein quality. Strategies and techniques to help achieve optimal yield, consistent quality and performance will be discussed.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Single-Chain Antibody Process Development - Challenges and Solutions Sushil Gupta, Principal Scientist, Syngene International, India
Delivered cell culture processes for clinical and commercial supply for novel full-length antibodies, novel single-chain-Fv-Fc, biosimilars Rituximab, Bevacizumab, Erythropoietin and Darbepoietin. Achieved 4 g/L titer for novel mAb expressed in CHO. Scale up and technology transfer of cell culture processes. Process development of products from insect cell expression systems (SF9), microbial & Pichia based expression system.
An engineered single-chain antibody (scFv fused to Fc with a linker), was expressed in recombinant CHO cell lines. To achieve high titer and product quality, two expression vector and cell line systems were explored. Using a statistical approach, several basal and feed media were screened to arrive at optimal medium and feed combinations. Counter-intuitive results were observed during clone selection; clones from the same pool favored different basal and feed media combinations to reach higher levels of titer. The specific productivity was increased and was maintained throughout the course of culture by optimizing feed rate and biphasic temperature conditions. Process parameters such as pH, temperature, high seed density culture, different feed regimen, amino-acid profiles as well as balanced glucose feeding and lactate maintenance, and feed rate interaction with temperature-shift were studied in order to increase viable cell count, specific productivity rate and culture longevity. Through optimized cell culture conditions, a titer of 3.0 g/L was achieved in one cell line without compromising the quality of the product. In this talk, we will present the effectiveness of parallel approaches in cell line development, the utility of statistical and semi-empirical approaches in cell culture development.
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Overcoming the Challenges in Purification of PEGlyated Proteins Shuichi Yamamoto, Director, Biomedical Engineering Center, Yamaguchi University, Japan He received a BS degree in 1976, a MS in 1978 and a Ph. D in 1981 in the department of Food Science and technology at Kyoto University. He has been at Yamaguchi University since 1981 (Assistant Professor 1981-1988, Associate Professor 1989-1997, Professor 1998-present). He has published more than 100 scientific papers. Among them, his monograph published in 1988 by Marcel Dekker "Ion-Exchange Chromatography of Proteins" is well-known. His chromatography model better known as "Yamamoto Model" and “Yamamoto number” has been employed by various biotech companies as well as by academic researchers. It is partly explained in Perry's Chemical Engineering Handbook (pp.16-44, 16-45). A text book “Bioseparations Science and Engineering” by R.G.Harris et al. (Oxford press, 2003) describes in detail how to use his model with a Yamamoto number. His diffusion-based drying model is also called “Yamamoto model” as well, and has been used by many researchers. He is a sub project leader of the National research project (Manufacturing Technology Association of Biologics).
Analysis of PEGylated protein separation by ion-exchange chromatography based on the mechanistic model Mechanistic understanding of the separation mechanism of positional isomers and PEGmers Optimization for the very high speed separation within minutes
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New Advances in Protein Purification Methods For Scale-Up of Downstream Processes Neha Kothari, Associate Research Scientist, International Vaccine Institute, Korea Neha Kothari started her career in Vaccine Research in year 2004 while working with Panacea Biotec Ltd. for the development of a bacterial polysaccharide conjugate vaccine at the R&D division. She later worked for other vaccine manufacturer Biological E in Hyderabad India for development of polysaccharide conjugate vaccine against Neisseria meningitis which included upstream optimization and quality control testing of capsular polysaccharide. In 2008 she joined IVI as an Associate Research Scientist in Vaccine Process Development Unit of Laboratory Science Division and played a vital role in process development and technology transfer of Vi-DT conjugate vaccine against Salmonella typhi. Her research focuses towards the development of highly efficacious cost effective vaccines against infectious diseases prevalent in developing world. She has wide experience in all steps of the vaccine development process that would be valuable in developing new vaccines and biologics.
Uncovering novel methods and new developments for the purificati on of downstream products Maximizing protein yields through cost-effective methods Process economy maximization and recovery and purification proce ss development for vaccine production
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New Purification Processes Based on Keystone Contaminant Management Wei Zhang, Research Scientist, Downstream Processing, Bioprocessing Technology Institute, Singapore Dr. Zhang Wei is a research scientist in Bioprocessing Technology Institute (BTI) of Singapore, and currently leads the downstream processing group. She obtained her Ph.D degree from Singapore-MIT Alliance under the supervision of Prof. Daniel I.C.Wang. She worked in Codexis Laboratories Singapore as Technical Lead for 3 years before joining in BTI. Her group in BTI has been dedicated to working on the development of next generation bioseparation. In particular, they have developed novel purification technologies for monoclonal antibody production, which will reduce manufacturing costs, increase productivity, and improve product safety and efficacy.
A Keystone contaminant is a contaminant that affects the behavior of other contaminants. This occurs mainly through meta-stable associations among contaminant species where the keystone acts as a nucleation center for accretion of other contaminants. Chromatin as the keystone contaminant in CHO harvests imposes disproportionately large effects on downstream processing, it interferes directly with every aspect of chromatography, mostly at capture, but significantly at subsequent steps as well. We have developed a fast and effective chromatin extraction method, which is conducted during the clarification ahead of the protein A chromatography. This advance clarification method not only helps eliminate one column step, but also dramatically improves all performance parameters. Our new protein A paradigm for IgG production surpasses current prevailing protein A processes in many aspects.
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Upgrading Platform Processes for Antibody Manufacturing to Increase Productivity Kunihiko Kodaira, Downstream Process Development, Chugai Pharmaceuticals, Japan Dr. Kunihiko Kodaira leads the downstream process development group in Chugai Pharmaceutical Company of Japan. Dr. Kodaira obtained his Ph.D degree for the study about novel cytokines purified from cell culture fluid from Saitama Medical Institute in Japan. Dr. Kodaira has over 20 years’ experience in biopharmaceutical industry. He has joined Chugai since 2001, then served as a specialist for cytokine purification in Chugai research department. Then, he also served as a Pharmaceutical Technology (CMC) Leader for Chugai-origin and also Roche-origin products. He has been dedicated to working on the process development not only downstream process but also upstream process.
Higher productivity and more efficient impurity clearance are re quired in the purification process against the background of tit er increase in the cultivation process and higher quality requirem ents from health authorities Introducing a platform process to reduce time and cost for antibody process development and manufacturing Discussing the need for continuous upgrading of processes, to increase productivity
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Batch to Continuous Processing: What Is Holding the Industry Back from Executing Continuous Processing? Steven Lee, Founder & Chief Executive Officer, BioGENEXUS, USA (Moderator) Dr Steven Lee is founder and CEO of BioGENEXUS Singapore, aiming to develop affordable biologics for emerging markets. Dr Steven Lee was previously the Global Head, Biologics Development for Luye Pharma Group (China) while serving as CEO of A-Bio Pharma in SIngapore. Dr. Lee received his Ph.D. in Biochemical Engineering from MIT. He has a broad range of leadership experiences in business development, organization tranformation, bioprpocess development and biologics manufacturing of many biological products including natural products, vaccines, protein therapeutics and blood factors. Prior to joining A-Bio in 2008, Dr. Lee has 20+years experience in global biopharmaceutical industry, working for Roche, Merck and Bristol-Myers Squibb, where he served as Vice President and General Manager, Process Development and Biologics Manufacturing. Dr. Lee had built and led many biotech teams in developing and launching a many biologics drug, most noteworthy in 2006 obtaining worldwide approval of Orencia®, BMS's very first internally developed biologics for rheumatoid arthritis.
Jeong Won Yun, Vice President, Head of Manufacturing, Celltrion, Korea (Panelist) Jeong Won currently serves as Vice-President in Celltrion, leading the Manufacturing Division which is responsible for the cell culture, purification, fill and finish GMP productions, as well as overseeing the facility operations and maintenance of the manufacturing facility. He has over 25 years of industry experience, and has extensive expertise in plant cell culture and animal cell culture process development, upstream & downstream process development, including design & construction of cGMP manufacturing facilities.
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Scott Liu, President & Chief Executive Officer, Henlius Biopharmaceuticals, USA (Panelist) Dr. Scott Liu, graduated from Purdue University, Department of Biology, was a postdoctoral fellow at Stanford University, and later pursued iMBA courses at Syracuse University. As the Founder, President and CEO of Henlius Biopharmaceuticals, Inc. and Shanghai Henlius Biotech Co., Ltd., he takes overall responsibility for strategic planning and implementation, as well as operation management. Benefiting from Scott’s vision in achieving quality at reasonable cost, Shanghai Henlius Biotech Co., Ltd. has adopted advanced technologies in mAb development and manufacturing, and, in doing so, significantly reduced the manufacturing costs while maintaining the quality of the products. Before founding his own companies, Scott held key technical and/or leadership positions in several leading biopharmaceutical companies, including Amgen, Bristol-Myers Squibb, United Biomedicals (UBI), Tanox and Maxygen. He was the Director of Quality Analytical Labs of Amgen-Fremont, and took responsibility for quality control operations for late-phase development and cGMP commercial manufacturing of Vectibix. Prior to Amgen, Scott held the post of Associate Director of Biologics QC in BMS-Syracuse, he was in charge of QC operations for late phase development and commercial manufacturing of Orencia. Dr. Liu has 20 years’ experience of biopharmaceutical development, manufacturing, drug administration and quality management , and he won the title of " 1000 Planning Expert of Shanghai " in 2013.
Shuichi Yamamoto, Director, Biomedical Engineering Center, Yamaguchi University, Japan (Panelist) He received a BS degree in 1976, a MS in 1978 and a Ph. D in 1981 in the department of Food Science and technology at Kyoto University. He has been at Yamaguchi University since 1981 (Assistant Professor 1981-1988, Associate Professor 1989-1997, Professor 1998-present). He has published more than 100 scientific papers. Among them, his monograph published in 1988 by Marcel Dekker "Ion-Exchange Chromatography of Proteins" is well-known. His chromatography model better known as "Yamamoto Model" and “Yamamoto number” has been employed by various biotech companies as
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
well as by academic researchers. It is partly explained in Perry's Chemical Engineering Handbook (pp.16-44, 16-45). A text book “Bioseparations Science and Engineering” by R.G.Harris et al. (Oxford press, 2003) describes in detail how to use his model with a Yamamoto number. His diffusion-based drying model is also called “Yamamoto model” as well, and has been used by many researchers. He is a sub project leader of the National research project (Manufacturing Technology Association of Biologics).
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Workshop with PALL LIFE SCIENCES: SingleUse, Continuous Bioprocessing: Value Proposition & How to Get Started Rob Noel, Business and New Technologies Development, PALL Life Sciences, UK Rob Noel is Business Manager for Pall Life Sciences working in Strategic Marketing. He is responsible for commercialising products and services for Flexible Manufacturing including Continuous Processing. He has over 20 years’ experience of downstream purification in contract manufacturing, process development and business development. Has supported process solutions in biotech, plasma processing, vaccine facilities and food installations. PhD in biochemical engineering and MSc in bimolecular organisation.
The value proposition of integrated systems An update on the state of art and what is currently available Key features of an integrated purification unit at development scale and for GMP manufacturing.
Conference Day TWO 30 June 2016, Thursday
Conference Day ONE 16 October 2013, Wednesday
CONFERENCE AGENDA Thursday, June 30, 2016 IMAPAC’s Welcome Back Remarks
8:55 a.m.
Chairman’s Opening Remarks
9:00 a.m.
Demonstrating Comparability of mAbs: Method Validation & Transfer to Ensure Quality & Comparability Jeffrey Su, Executive Vice President & Chief Operating Officer, Sorrento Therapeutics, USA
9:25 a.m.
Exhibits Open
8:50 a.m.
Applying Analytical Methods in Upstream Development and Impact of Process Changes on the CQA’s of mAb’s George Wang, CEO and President, Mab-Venture Biopharm, China
9:50 a.m.
Addressing the Challenges in Glycomic Characterization of Commercial Manufacturing of Novel Biologics Hyun Joo An, Professor, Chongnam National University; Director, Asia-Pacific Glycomics Reference Site (AGRS), Korea
10:15 a.m.
Morning Refreshment
10:45 a.m.
Developing a Cost-Effective Universal Allogeneic Cell Therapy Ramkumar Mandalam, CEO, Cellerant Therapeutics, USA
11:10 a.m.
Practical Cost Reduction Strategies on Mass Production of Stem Cell Therapies Seung-Hee Lee, Deputy Director, Senior Researcher, Kang Stem Biotech, Korea
11:35 a.m.
Manufacture of Clinical-grade SCM-CGH from Single Colonies Based on the Subfractionation Culturing Method Sun U. Song, CEO, SCM Lifescience, Korea
12:00 a.m.
Networking Luncheon
1:00 p.m.
Biomanufacturing Excellence Through Single-Use Bioreactors Chris Chen, CEO, Wu Xi Biologics, China
1:25 p.m.
Case Study: From Clone to 2000 L Scale, A Fast Progress to Biosimilar Karen Wen, President, Mycenax Biotech Inc., Taiwan
1:50 p.m.
Cell-Line Development for Cell Culture Based Influenza Vaccine
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Dong-Ho Ahn, Vice President, Head of Vaccine Process Development Unit, Green Cross, Korea
2:15 p.m.
Who Will Manufacture Vaccines for the Next Emerging Global Diseases? Alan Liss, Founder & CEO, GXP Farma LLC, USA
2:40 p.m.
Coping with the Process Development Challenges and Scale-up to Industrial Production of Viral Vaccines Ravi Ganapathy, Associate Vice President, Biological E Ltd, India
3:05 p.m.
Afternoon Refreshment
3:30 p.m.
Expectations on Biopharmaceutical Production Facilities: Do Our Actual Standards Provide Excellence? Ruediger Mechsner, Principal Consultant, Samsung Engineering, Korea
3:55 p.m.
Case Study: The Journey to Build the World’s Largest Single-Use Modular Facility in China Nick Kotlarski, Vice President, Engineering & Validation, JHL Biotech, Taiwan
4:20 p.m.
Considerations for Adoption of Single-Use Systems - A Regulator's Perspective Mei-Fang Chen, Senior Reviewer, Taiwan Food and Drug Administration, Taiwan
4:45 p.m.
Facilities of the Future: Increasing Flexibility, Enhancing Speed, Decreasing Costs Ruediger Mechsner, Principal Consultant, Samsung Engineering, Korea (Moderator) Chris Chen, CEO, Wu Xi Biologics, China (Panelist) Steven Lee, Founder & Chief Executive Officer, BioGENEXUS, USA (Panelist) Jeffrey Su, Executive Vice President & Chief Operating Officer, Sorrento Therapeutics, USA (Panelist) Nick Kotlarski, Vice President, Engineering & Validation, JHL Biotech, Taiwan (Panelist)
5:35 p.m.
Chairman’s Closing Remarks | End of Biologics World Korea 2016
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Demonstrating Comparability of mAbs: Method Validation & Transfer to Ensure Quality & Comparability Jeffrey Su, Executive Vice President & Chief Operating Officer, Sorrento Therapeutics, USA
Applying Analytical Methods in Upstream Development and Impact of Process Changes on the CQA’s of mAb’s George Wang, CEO and President, Mab-Venture Biopharm, China
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Addressing the Challenges in Glycomic Characterization of Commercial Manufacturing of Novel Biologics Hyun Joo An, Professor, Chongnam National University; Director, Asia-Pacific Glycomics Reference Site (AGRS), Korea Dr. Hyun Joo An is the director of the Asia-Pacific Glycomics Reference Site (AGRS), which develops and validates new anlaytical platforms for glycomic and glycoproteomic analysis in collaboration with government agencies and regional industry. Since 2011, Dr. An has been a professor at Chungnam National University. She received her BS and MS degrees from Inha University (Incheon, Korea) and her PhD from the University of California at Davis (Uniter states). Dr. An’s research focuses on bioanalytical mass spectrometry, with applications to glycomics, proteomics, glycoproteomics and glycolipidomics. Her specific research interests include bioanalytical method development, biopharmaceutical characterization, disease biomarker discovery, post mortem interval (PMI) marker discovery, brain glycome mapping, and glycobiology. She has authored and coauthored over 80 peer-reviewed publications on these subjects, and holds multiple related patents.
Detailed glycomic analyses are necessary to assess biotherapeut ic quality. The quality, safety and potency of recombinant erythropoietins are determined largely by their glycosylation Analytical platform for glycomic characterization of a recombinant erythropoietin biotherapeutics by MS will be discussed How to ensure a successful transfer and reproducibility of conjugation process with solid analytics will be discussed
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Developing a Cost-Effective Universal Allogeneic Cell Therapy Ramkumar Mandalam, CEO, Cellerant Therapeutics, USA Ram Mandalam, is President and CEO of Cellerant Therapeutics since 2005. Ram was previously Executive Director of Product Development at Geron Corporation, where he managed the development and manufacturing of cell based therapies for treatment of degenerative diseases and cancer. Prior to Geron, he was Director of Developmental Research at Aastrom Biosciences, where he was responsible for the research and development programs involving ex vivo expansion of human bone marrow stem cells and dendritic cells. Dr. Mandalam received his Ph.D. in Chemical Engineering from the University of Michigan. Dr. Mandalam is the author or co-author of several publications, patent applications, and abstracts.
The importance of starting material characterization Effective scale-up strategies for the large scale manufacturing of cell therapies Development of release assays for the high-purity Cost of Goods analysis for cell therapy development
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Practical Cost Reduction Strategies on Mass Production of Stem Cell Therapies Seung-Hee Lee, Deputy Director, Senior Researcher, Kang Stem Biotech, Korea Dr. Lee leads the regenerative medicine and stem cell research center at Kangstem Biotech. She obtained her PhD in Veterinary Medicine from Seoul National University, where she specialized in the epigenetic regulation of aging in MSCs. She was involved in several research projects and led her team to discover & develop many stem cell related products at Kangstem. She has extensive experience in the emerging field of stem cell therapy & medicine, and hopes to bring affordable healthcare to patients in need.
Recently, the need for development of stem cell therapeutics is increasing for rare and incurable diseases. Until now, 6 stem cell therapeutics were approved in the worldwide and among them, 4 stem cell therapeutics were approved in Korea. In this presentation, the representative cell culture methods for adherent cells will be addressed, and 3D culture system using microcarriers will be compared to that in the aspects of yield, usability, and characteristics of the cells. Additionally, some parts of the results in our company will be introduced as examples. Moreover, the manufacturing procedures that are suitable for costreduction and production efficiency in the development of cell therapeutics based on the Korean regulation will be discussed.
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Manufacture of Clinical-grade SCM-CGH from Single Colonies Based on the Subfractionation Culturing Method Sun U. Song, CEO, SCM Lifescience, Korea Dr. Song is currently CEO of SCM Lifescience, which was founded in 2014 with a vision of treating incurable diseases by using the natural properties of adult stem cells. He obtained his PhD from John Hopkins University, and is also serving as Director at the Translational Research Center, at the Inha University Hospital, and Professor at the School of Medicine, Inha University. He is also editor for the World Journal of Stem Cells, since 2009.
Stem cell products derived from mesenchymal stem cells (MSCs) have been widely used in clinical trials, and a few products have been already commercialized. However, the therapeutic effects of clinical-grade MSCs are still controversial owing to mixed results from recent clinical trials. A potential solution to overcome this hurdle may be to use clonal stem cells as the starting cell material to increase the homogeneity of the final stem cell products. We have developed an alternative isolation and manufacture protocol for establishing a population of clonal MSCs (cMSCs) from single colony forming unit (CFU)-derived colonies. In this talk, a good manufacturing practice (GMP)compatible procedure for the clinical-grade production of SCM-CGH which is a cMSC product based on the subfractionation culturing method for the treatment of chronic graft-versus-host disease (GvHD) will be described. We optimized the culture procedures to expand and obtain a clonal population of final MSC products from single CFU-derived colonies in a GMP facility. The characterization results of the final cMSC products met our preset criteria. Animal toxicity tests were performed in a good laboratory practice facility, and showed no toxicity or tumor formation in vivo. These tests include single injection toxicity, multiple injection toxicity, biodistribution analysis, and tumorigenicity tests in vivo. No chromosomal abnormalities were detected by in situ karyotyping using oligofluorescence in situ hydridization (oligo-FISH), providing evidence of genetic stability of the clinical-grade cMSC products. The manufacture and quality control results indicated that our GMP methodology could produce sufficient clonal population of MSC products from a small amount of bone marrow aspirate to treat a number of patients.
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Biomanufacturing Excellence Through SingleUse Bioreactors Chris Chen, CEO, Wu Xi Biologics, China Dr. Chris Chen is currently CEO of Wuxi Biologics Co Ltd, a leading biologics service business in China. His previous assignments include director and manager positions of bioprocess development, technical service, and pilot plant operations at Lilly and Merck. He also served as Chief Operating Officer for Shanghai Celgen Biopharmaceuticals, successfully developed a high-titer highquality commercial process for biosimilar Enbrel, and obtained regulatory approval for the program in China. In 2009, he co-founded Shanghai Kanda Biotechnology Co Ltd and served as Chief Executive Officer. He is proficient at mAb development strategy, high titer cell culture development, large-scale mammalian cell culture, and regulatory and quality of mAb manufacturing. Overall he has participated in developing 11 mAb programs in US and another 10 in China. He chaired multiple conferences in biochemical engineering and mAb development in US and China and is frequently invited to speak at multiple conferences.
Single-use bioreactors as cost-effective systems with increased speed, scalability & flexibility for multi-drug production Facility design as an important factor in complimenting single-use systems Advantages & limitations of disposable manufacturing and continuous processing
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Case Study: From Clone to 2000 L Scale, A Fast Progress to Biosimilar Karen Wen, President, Mycenax Biotech Inc., Taiwan 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 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 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.
Mycenax is a CMC based company in biological product development with selected biosimilars as the first stage pipeline. Speed and competitive pricing strategy are the key elements besides its similarity. Disposable technology has been applied in Mycenax from 2004 and 2000L scale is the maximum scale in house. The comparability study is demonstrated for each scale up process. In order to facilitate the scaling up process and minimizing the comparability studies, we develop an one-step scaling up process of monoclonal antibody products from a 5L scale to either 500L or 2000L scale. This platform can be applied not only in biosimialrs but also in bionovels development and shorten the time required for IND.
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Cell-Line Development for Cell Culture Based Influenza Vaccine Dong-Ho Ahn, Vice President, Head of Vaccine Process Development Unit, Green Cross, Korea Dr. Dong-Ho Ahn is Vice-President and Head of the Vaccine Process Development Unit at the Central Research Center in Green Cross. He leads the development of innovative vaccines against infectious diseases. He obtained his PhD in Applied Microbiology from KAIST, where he specialized in molecular biology. Dr. Ahn has more than 30 years of experience in the vaccines industry, and was previously Vice-President of Genexine, where he was responsible for the development of DNA vaccines and Fc-fused protein drugs, and he was also senior scientist at CJ, where he developed various vaccines and recombinant protein drugs. Influenza is a major cause of acute respiratory infection. Annual epidemics result in about three to five million cases of severe illness and about 250,000 – 500,000 deaths. Most human Influenza vaccines have been produced in embryonated hen’s egg, But recently cell culture based production have gained attention as an alternative method due to the rapid and easier scale up production. A modified MDCK cell-line (MDCKS-MG) was grown in suspension. We investigated the HA titers during infection with cell or egg-passaged viruses and compared the genetic stability of cell- passaged viruses. Amino acid sequences of HA and NA were analyzed and compared to the reference sequences.
The Novel MDCKS-MG cell line exhibits high and relatively uniform productivity for various strains. The phenotypical change of suspension growth does not increase the tumorigenicity and does not show oncogenicity in animal studies. A robust cultivation and purification process has been developed, and currently the phase 3 clinical trials of cell culture quadri-valent Influenza vaccine are being conducted now.
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Who Will Manufacture Vaccines for the Next Emerging Global Diseases? Alan Liss, Founder & CEO, GXP Farma LLC, USA Dr. Alan Liss has over 25 years of successful experience in the area of applied microbiology and biotechnology. He has focused on establishing and maintaining high quality pharmaceutical project management systems - directing teams of scientists and support staff to improve manufacturing efficiency and GXP regulatory compliance. Alan retired in late 2014 as the Director of the Public Health and Security Action Team Program of the US Food and Drug Administration Commissioner’s Medical Countermeasures Initiative in Washington, DC. Prior to assuming that position, he organized the creation of the Regulatory and Quality Division for the Biomedical Advanced Research and Development Authority (BARDA) of HHS/ASPR. Alan has worked in private industry as Senior Director, Biotechnology and Project Management for Duramed Research, Inc. (a Division of Teva/Barr Pharmaceuticals, Inc.); Vice President, Product Development for Antex Biologics, Inc.; Site Director, Quality Assurance and Quality Control for Wyeth Pharmaceuticals Inc.; Senior Director of Quality Assurance and Regulatory Affairs for Aventis Bio-Services, Inc.; and Director of Quality Assurance and Quality Control for the Institute of Molecular Biology. Dr. Liss received a B.S. degree in Genetics from the University of California, Berkeley, and a Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine and Dentistry.
What and Why of Emerging Infectious Diseases (EID) How we are responding to current threats? Looking at modeling EID response developed by US DHHS and determining if it can work globally
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Coping with the Process Development Challenges and Scale-up to Industrial Production of Viral Vaccines Ravi Ganapathy, Associate Vice President, Biological E Ltd, India With a PhD in Biotechnology, Dr. Ravi Ganapathy has 22+ years of experience in varied environments viz. Manufacturing, Research & Development and Quality functions in biotech, R&D and Health industries. Over 19 years of his experience is in vaccine industry, which includes leading teams on recombinant (bacterial/yeast-based) and viral vaccine development and production divisions. Currently, as Associate Vice President, he is heading the Manufacturing Sciences group of Biological E Ltd., Hyderabad, India, which is the largest among the WHO pre-qualified suppliers of Liquid Pentavalent (DTP-Hep.B-Hib), along with Hepatitis-B and Inactivated Japanese Encephalitis vaccines to UNICEF/PAHO. Dr. Ravi has extensively worked and led teams in product development and clinical material production for a recombinant Hep.B, two Rotavirus, a Pandemic Flu (H1N1, 2009) and four Malaria vaccine candidates; three of those candidates have been successfully commercialized and one each have completed Ph-I and Ph-III trials. Dr. Ravi has published seven research articles and has a patent filed for an adjuvant-preparation procedure. He has given talks in various conferences, Continuing Medical Education (CME) programmes, universities; and attended workshops abroad on Malaria and Adjuvants organized/sponsored by WHO and BGMF.
Vaccines have been hailed as one of the most important public health advances in human history. Vaccines save lives by preventing the transmission and consequences of infectious diseases, and are unique among medical products in that they protect health at both the individual and the community level. Thus, vaccines are not only the model of prevention, but also best represent the convergence of medicine and public health.
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Unlike traditional pharmaceuticals, vaccines are biological medicines based on living organisms and are intended for use in healthy individuals as a preventive measure; so they must meet specific, extensive regulatory requirements throughout their development, production and distribution cycles. Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement. General stages in vaccine development are Exploratory, Pre-clinical, Phases-1, 2, 3 (pre-approval) & 4 (post-approval/post-marketing/pharmacovigilance) Clinical Trials. Several types of vaccines are whole-organism (live/inactivated), purified macromolecules, toxoids, recombinant molecules, DNA-based, synthetic peptides & multivalent. Manufacturing a vaccine, after the hard task of `development’ in the laboratory, is a complicated process. The change from manufacturing a potential vaccine in small quantities to manufacturing a safe vaccine in a production situation is dramatic, with all issues related to "scale up". Vaccine manufacturing involves several production and testing processes to ensure that product delivered is assured of the quality, safety, and efficacy. The production methods/technologies/tools vary depending on the type of vaccine, antigen produced, scale of production and purity of the final product. Antigen production is followed by the formulation process with/without adjuvants, preservatives, stabilizers, etc. depending on the presentation. The final step is packaging (filling, lyophilisation-if applicable, stoppering/sealing, labelling & final packing), which also depends on the intended presentation/delivery system. The salient aspects of the vaccine development, production processes, challenges in these endeavours, especially with respect to viral vaccines and ways to cope with them are covered in this talk.
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Expectations on Biopharmaceutical Production Facilities: Do Our Actual Standards Provide Excellence? Ruediger Mechsner, Principal Consultant, Samsung Engineering, Korea Principal Engineer, SAMSUNG Engineering, Korea Establishing knowledge base for engineering of biopharmaceutical plants. Training and coaching of staff. Technological supervisor and consultant for biotech projects within Samsung Engineering. Expert supervisor for Edison II project engineering. Operational Excellence in BioPharma asks for always safer, more effective, and better available drugs that should be producible in a faster, leaner, and customizable way. These Maxims are directly mirrored into the requirements on manufacturing facility concepts. We understand our mission as Engineers to realize the required excellence by offering the best technical design options. Since the 90‘s, the typical production platform for large scale mAb and ammalian expressed Biologics has been established. This platform still represents state of the art as a reference for a mature, robust and predictable production method. The high demands for blockbuster mAb products were quickly covered by large installations with high production volumes. Since the year 2000, every year there came 1-2 large scale production facilities into operation with stainless steel Bioreactor volumes of total 60 to 200m3. And for the next coming years, further facilities of this size are planned. Growing demands of Biologics were mostly covered by larger production volumes and by steadily increasing roductivity. It was possible to boost upstream output 3 fold through increasing the product titer. At the same time, however, the downstream remained the bottleneck as the efficiency of the purification process has increased by only 30%.
The next step for production excellence are continuous operation concepts. Those have the potential to decrease the required production volumes significantly allow to install SU equipment units with same output as actual large scale ss facilities. If more relaxed environmental controls (room-concepts) will be tolerated and if entire processing steps can be omitted, very simple manufacturing concepts are actually possible. In my presentation, I highlight some key process concepts like perfusion cultivation and continuous purification methods. The required technologies are not new, they are technically realisable, but still not generally applied.
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I will further describe the possibilities to apply requirements on excellence into facility and realization concepts. Depending on the production volume, the three established facilitymodels are „stainless steel Installations“, hybrid installations (ss and single use), as well as fully modularized SU concepts for smaller demands. I am presenting the methods and possibilities how to built facilities in a fast, lean, and flexible way. By comparing on site construction with super-skids, modular units with hard-piped integration and stainless steel with disposables, the physical limitations of the compared technologies are pointed out.
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Case Study: The Journey to Build the World’s Largest Single-Use Modular Facility in China Nick Kotlarski, Vice President, Engineering & Validation, JHL Biotech, Taiwan Nick is a Biopharmaceutical Engineer with more than 17 years of experience. As the head of Engineering and Validation for JHL Biotech since 2013, he has been responsible for the design and validation of a 4,500 m2 research centre and cell culture pilot plant in Taiwan and delivery of a 22,000m2 greenfield commercial manufacturing plant in China. Throughout his career Nick has worked in the development of commercial bioprocesses including process development and scale-up from fermentation through to product formulation, facility design, and drug production registration. Prior to joining JHL Biotech, Nick managed a Singapore-based engineering consultancy and worked with clients throughout Asia to design, validate and operate manufacturing facilities in compliance with international Good Manufacturing Practices. He has also held production head responsibility for biopharmaceutical API and clinical product manufacture for a biotech company in Australia. Nick has a Bachelor of Engineering (Chem) and a Ph.D. in bioprocess scale-up from The University of Adelaide. He is a Charted Engineer and Member of the Institution of Chemical Engineers.
This presentation will review the considerations leading to the selection of singleuse and modular technologies and the approaches taken to achieve fast-track construction and rapid start-up of the biologics facilities in Taiwan and Wuhan. The talk will focus on the commercial manufacturing facility in Wuhan, that includes the world’s largest modular single-use cell culture facility, and how this advances the Company towards achieving its vision.
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BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Considerations for Adoption of Single-Use Systems - A Regulator's Perspective Mei-Fang Chen, Senior Reviewer, Taiwan Food and Drug Administration, Taiwan Single- use system has its advantages to decrease the risk of contaminations and reduce downtime for clean validation and process engineering. Most materials of contact layer of single use system are made of the plastic materials. TFDA has a limited direct regulations covering these single use systems, but based on the attributes of the plastics, TFDA will follow the international guidelines, such as European pharmacopeia <3.1> materials used for the manufacture of containers, USP<661.1>Plastic Materials of Construction, USP<87> and USP<88> about biosafety testing and guideline on immediate packaging materials (EMA). Generally speaking, if the plastic materials are mentioned in the Pharmacopeia, such as the PP, PVC, PE, poly(ethylene-vinyl acetate) and so on., the tests just followed the specification of Pharmacopeia. A control strategy may be proposed for systems where safety assessment indicates that there is an ongoing risk from leachable which cannot be mitigated by the one-off studies during the development. Threshold limit for safety assessment are commonly employed.
If the sponsor changed the manufacture processes from the stainless steel to disposable bags, the points of review are not only on safety assessment but also on the quality issues. Comparability studies are suggested to perform based on the ICH Q5E to prove the quality of drug substance or drug product comparable. For the advance of manufacturing processes and novel bioanalytical methods by the industry recently, the smooth communication platform is necessary for regulatory systems and industries to reach the consensus.
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Facilities of the Future: Increasing Flexibility, Enhancing Speed, Decreasing Costs Ruediger Mechsner, Principal Consultant, Samsung Engineering, Korea (Moderator) Principal Engineer, SAMSUNG Engineering, Korea Establishing knowledge base for engineering of biopharmaceutical plants. Training and coaching of staff. Technological supervisor and consultant for biotech projects within Samsung Engineering. Expert supervisor for Edison II project engineering.
Chris Chen, CEO, Wu Xi Biologics, China (Panelist) Dr. Chris Chen is currently CEO of Wuxi Biologics Co Ltd, a leading biologics service business in China. His previous assignments include director and manager positions of bioprocess development, technical service, and pilot plant operations at Lilly and Merck. He also served as Chief Operating Officer for Shanghai Celgen Biopharmaceuticals, successfully developed a high-titer highquality commercial process for biosimilar Enbrel, and obtained regulatory approval for the program in China. In 2009, he co-founded Shanghai Kanda Biotechnology Co Ltd and served as Chief Executive Officer. He is proficient at mAb development strategy, high titer cell culture development, large-scale mammalian cell culture, and regulatory and quality of mAb manufacturing. Overall he has participated in developing 11 mAb programs in US and another 10 in China. He chaired multiple conferences in biochemical engineering and mAb development in US and China and is frequently invited to speak at multiple conferences.
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS http://www.imapac.com/business_conference/biologics-world-korea-2016/
Steven Lee, Founder & Chief Executive Officer, BioGENEXUS, USA (Panelist) Dr Steven Lee is founder and CEO of BioGENEXUS Singapore, aiming to develop affordable biologics for emerging markets. Dr Steven Lee was previously the Global Head, Biologics Development for Luye Pharma Group (China) while serving as CEO of A-Bio Pharma in SIngapore. Dr. Lee received his Ph.D. in Biochemical Engineering from MIT. He has a broad range of leadership experiences in business development, organization tranformation, bioprpocess development and biologics manufacturing of many biological products including natural products, vaccines, protein therapeutics and blood factors. Prior to joining A-Bio in 2008, Dr. Lee has 20+years experience in global biopharmaceutical industry, working for Roche, Merck and Bristol-Myers Squibb, where he served as Vice President and General Manager, Process Development and Biologics Manufacturing. Dr. Lee had built and led many biotech teams in developing and launching a many biologics drug, most noteworthy in 2006 obtaining worldwide approval of Orencia®, BMS's very first internally developed biologics for rheumatoid arthritis.
Jeffrey Su, Executive Vice President & Chief Operating Officer, Sorrento Therapeutics, USA (Panelist)
Nick Kotlarski, Vice President, Engineering & Validation, JHL Biotech, Taiwan (Panelist) Nick is a Biopharmaceutical Engineer with more than 17 years of experience. As the head of Engineering and Validation for JHL Biotech since 2013, he has been responsible for the design and validation of a 4,500 m2 research centre and cell culture pilot plant in Taiwan and delivery of a 22,000m2 greenfield commercial manufacturing plant in China. Throughout his career Nick has worked in the development of commercial bioprocesses including process development and scale-up from fermentation through to product formulation, facility design, and drug production registration. Prior to joining JHL Biotech, Nick managed a Singapore-based engineering consultancy and worked with clients throughout Asia to design, validate and
BIOLOGICS WORLD KOREA 2016 CONFERENCE PROCEEDINGS ď&#x20AC;¸ď&#x20AC; http://www.imapac.com/business_conference/biologics-world-korea-2016/
operate manufacturing facilities in compliance with international Good Manufacturing Practices. He has also held production head responsibility for biopharmaceutical API and clinical product manufacture for a biotech company in Australia. Nick has a Bachelor of Engineering (Chem) and a Ph.D. in bioprocess scale-up from The University of Adelaide. He is a Charted Engineer and Member of the Institution of Chemical Engineers.
CONFERENCE EVALUATION CHAIRMAN / SPEAKER ASSESSMENT E = Excellent
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Conference Day 1 Speaker
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9 June 2015 / Tuesday
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Uwe Gottschalk
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Sushil Gupta
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Jeong Won Yun
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Shuichi Yamamoto
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Sun Bae Lee
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Neha Kothari
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Kara Calhoun
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Zhang Wei
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Jung Wook Hong
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Kunihiko Kodaira
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Weon-Kyoo You
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Jung Eun Lee
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Katsuyuki Takeuchi Yung Shyeng Tsao Matthias Brand
Speaker
Presentation Conference skills
Steven Lee (moderator) Jeong Won Yun (panelist) Scott Liu (panelist) Shuichi Y. (panelist) Rob Noel
Content Presentation Day 2 of 10 Speaker June 2015 / Wednesday session skills
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Jeffrey Su
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Alan Liss
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George Wang
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Ravi Ganapathy
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Hyun Joo An
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Ruediger Mechsner
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Ramkumar Mandlam
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Nick Kotlarski
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Seung-Hee Lee
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Mei-Fang Chen
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Sun U Song
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Ruediger M. (moderator)
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Chris Chen
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Chris Chen (panelist)
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Karen Wen
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Steven Lee (panelist)
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Dong-Ho Ahn
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Jeffrey Su (panelist)
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Nick Kotlarski (panelist)
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CONFERENCE VENUE / FACILITIES
Conference Room
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Catering
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CONFERENCE ASSESSMENT What were your "Must-achieve" objectives for the Biologics World Korea 2015 event? Were they met - If not, why?
Please highlight potential themes/sessions/topics that were not covered at Biologics World Korea 2015, that should be covered in 2016?
Are there any specific key-opinion-leaders/organizations you would like to hear from at our next Biologics World Korea 2016?
Which 4 "NEW" technology providers would you like to see showcase and present their products and solutions at the Biologics World Korea 2016 event?
Are you satisfied with the seniority and profile of the delegates that were present at the event? Would you have liked to meet delegates of any other profiles?
Could you list down reasons you would return for this event next year, based on your positive experience?
Would you recommend this conference to your colleagues/peers? Please provide your their details (name, jobtitle and company)
List 3 things we could do differently next year to improve your overall experience Learning: ______________________________________________________________________________ Networking: ____________________________________________________________________________ Others: ________________________________________________________________________________ THANK YOU!
Thank you for taking the time to complete this questionnaire. We value your opinions and comments, and will use this information to assist us in improving our service. Name Job Title
Company
THANKS TO OUR
Sponsors IMAPAC would like to thank the following sponsors for their support and contribution in making BIOLOGICS
WORLD
KOREA 2016 a success. Hope to see you again in 2017. GOLD SPONSOR BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit bd.com.
TECHNOLOGY & LUNCH SPONSOR TERUMO is one of the world’s leading medical technology companies and operates in more than 160 nations. Terumo, founded in 1921, develops, manufactures and distributes a broad range of world-class medical devices including the supply of drug delivery/injection devices to the pharmaceutical industry. Pharmaceutical Solutions Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specific requirements.
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TECHNOLOGY SHOWCASE SPONSOR PALL LIFE SCIENCES develops, manufactures, sells and services products to customers that conduct research in the life sciences field, or in the production of therapeutic biologicals, drugs, vaccines and other biopharmaceuticals in-vitro diagnostic and healthcare markets. The Biopharmaceuticals group within Pall Life Sciences addresses the sub-market segments like biotechnology, vaccines, plasma, active pharmaceutical ingredients (API) and the formulation/filling. For each submarket, Pall provides a broad range of advanced cell culture, filtration and separation solutions for each critical stage from drug development to production and provides validation services to assist drug manufacturers through the regulatory process and onto the market.
EXHIBITORS
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NOVO NORDISK PHARMATECH A/S was established in 1949 as FeF Chemicals, acquired by Novo Nordisk in 1986 and has been part of the pharmaceutical group since then. On 1 September 2015 the company’s name was changed to Novo Nordisk Pharmatech A/S. It is the leading worldwide supplier of recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds (Quats) for the pharmaceutical, biopharmaceutical and personal care industries. ……… Operating in Asia for 16 years, ALMAC PHARMACEUTICAL SERVICES PTE. LTD launched our Asia Pacific Headquarters in Singapore 2015, expanding our physical presence within the Asia Pacific region and expanding our full clinical supply chain management solution across the region. We’re fully staffed and equipped to support trials of any size and complexity. We support regionally formed trials as well as AsiaPacific elements of fully global studies. Visit us at stand no. 5 to find out more. Contact Us: Almac Pharmaceutical Services Pte. Ltd. (Asia Pacific Headquarters) 9 Changi South Street 3 # 01-01, Singapore 486361 info@almacgroup.com | + 65 6309 0728 ……… The Life Sciences business of GE HEALTHCARE exists to enable and accelerate molecular and precision medicine. We do this by helping our customers discover, make and use new medicines. Healthcare needs more precise diagnoses and treatments to improve patient outcomes, address the globally rising incidence of lifestyle and chronic diseases, and help reduce the $350 billion wasted each year on poorly-targeted medicines. -
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We empower researchers with the innovative tools and analytics to research and develop tomorrow’s therapeutics. We drive productivity for the biopharmaceutical industry and help create manufacturing capacity in under-served markets. We enable increasingly accurate diagnoses by providing advanced in vivo imaging agents & in vitro diagnostics. We are helping create the future of regenerative medicine and cell therapy with customers by providing novel tools, technologies and methods. We work on the things that matter to become trusted partners with our customers, combining our deep expertise, integrity, and heritage in diagnostics and biotechnology with an extensive global network and strength in infrastructure and services. We are a $4.0 billion business of GE Healthcare serving researchers, pharmaceutical companies, and clinicians.
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Enterprise: http://www.gelifesciences.com/webapp/wcs/stores/servlet/catalog/en/GELifeScienceskr/about-us/enterprise-solutions/ Homepage: http://www.gelifesciences.com/webapp/wcs/stores/servlet/Home/en/GELifeSciences-kr/ JHL KUBio story:http://kubio.campaignhosting.se/#vision ……… WATSON-MARLOW FLUID TECHNOLOGY GROUP (WMFTG) is the world leader in niche peristaltic pumps and associated fluid path technologies for the food, pharmaceutical, chemical and environmental industries. Comprising nine established brands, each with their own area of expertise, but together offering our customers unrivalled solutions for their pumping and fluid transfer applications
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