Biopharma Seminar (Antibody Drug)
March 21, Wednesday
|
E-1
10:30| 11:15 |
The latest trends of Antibody purification platform
Mr. Hiroaki Hamana Since a couple of years ago, the bio-pharmaceutical market has been growing and the purification process for the antibodies has also been improving day by day. It involves the robustness of the purification platform related to the high quality of the antibody, the speed of the development and cost reduction. In this conference, we would like to present “The latest trends of Antibody purification platform”. |
|---|---|
|
E-2
11:30| 12:15 |
Characterization of Biopharmaceutical by electric fourier transform mass spectrometer Orbitrap.
Mr. Daisuke Higo
 CMD Applications / Demo Dept., C&MS group LSMS Team, Thermo Fisher Scientific K.K. Characterization of biopharmaceutical is very important same as its development, which mass spectrometer can be analyzed and identified to its sequence and information. Electric fourier transform mass spectrometer, Orbitrap technology equipped with HPLC are possible to measure high resolution / accurate mass that can be decreased false positive hit in protein/peptide sequencing analysis. Especially, ETD, electron transfer dissociation, technique enables to PTMs analysis which is an impossible measurement in CID techniques.
|
|
E-3
13:00| 13:45 |
Introduction of Bio-drug Development Supporting Service Leveraging Original Peptide/Protein Producing Technologies.
Dr. Yoshimi KikuchiGeneral Manager, Biomaterial Research Group, Innovation Laboratories, AJINOMOTO CO., INC. AJINOMOTO Co., Inc. has offered pharmaceutical contract manufacturing services by applying our biotechnology and synthetic technology of year’s experience to meet customers’ various demands including HAPI or refined synthesis. In addition, AJINOMOTO Co., Inc. has newly launched contract manufacturing service for peptide APIs and contract expression service for proteins. Our original technology for these new services, AJIPHASE® and CORYNEX®, will be introduced in this presentation.
|
|
E-4
14:00| 14:45 |
"Superior analytical solutions for the characterization of biotherapeutics"
Mr. Hiroshi Sezaki
 Life Sciences and Chemical Analysis Application Engineer, Agilent Technologies In order to characterize new biological entities sufficiently and to ensure drug safety and efficacy it is crucial to use a broad array of orthogonal analytical techniques. Agilent offers bio-inert LC, LC-MS, CE and chip based approaches. In this seminar the newest solutions are presented such as the mAb Glycochip that will increase the productivity of the bioanalytical lab in biotherapeutic development , characterization and QA/QC.
|
|
E-5
15:15| 16:00 |
Capillary electrophoresis (CE) involving high sensitive CE-MS and other analytical technologies, accelerate the development of monoclonal antibodies for clinical use
Mr. Etsuo AraiPrincipal Consultant, Discovery, Life Sciences Application & Marketing, Beckman Coulter K.K.
Capillary electrophoresis is the technology to automate and standardize the traditional electrophoresis involving SDS-PAGE. This is now considerably remarkable as the solution to effectively support the heterogeneity analysis of the biopharmaceuticals involving the monoclonal antibodies for clinical use in their development processes and quality control. The utility of higher sensitive CE-MS technology based on the sheath-less sprayer will be also presented.
Analytical ultracentrifugation to check the aggregation level of the proteins, and the automatic image analysis system to measure the total cell number and the viability, will be also discussed. |
March 23, Friday
|
E-13
14:00| 14:45 |
The Strategies for production of Monoclonal Antibody.
-Optimization of the purification process for highly efficiency- 
Dr. Junichi InagawaTechnical Expert, BioProcess Division Technical Sales, Life Sciences, GE Healthcare Japan Monoclonal antibodies are drawing attention in the biopharmaceutical industries. Economic strategies are need for the production of the antibody because the amount of the production is extremely large scale. Recently many pharmaceutical companies tried to establish their platform technologies on both the upstream and downstream processes. In this lecture, we would like to present the strategies for the production of antibody therapies.
|
|---|
Biopharma Seminar (CMO)）
March 22, Thursday
|
E-6
10:30| 11:15 |
Contract Manufacturing Service for Biopharmaceuticals
Hiromichi Kumagai, Ph.D.ASPEX Division Fellow, ASAHI GLASS CO., LTD. AGC (Asahi Glass) has been offering contract GMP manufacturing service for the biopharmaceutical industry. The service covers full range of protein manufacturing, from expression to commercial production. In this presentation we show the details of the CMO service introducing our GMP facilities, including 300 L / 400 L / 4,500 L fermentors, and capability of process development.
|
|---|---|
|
E-7
Language
11:30INTERPRETATION EJ | 12:30 |
Implementation of a Single Use Manufacturing Platform for Operational Flexibility and Capacity Expansion
Dr. Stewart McNaullSection Leader, Upstream Process Development, Process Development (R&D), FUJIFILM Diosynth Biotechnologies FUJIFILM Diosynth Biotechnologies (FFDB) has a fifteen-year history of supplying clinical and commercial cell culture products using a stainless steel bioreactor platform. Recent increasing partner needs required a significant capacity expansion at FFDB with rapid delivery and low capital investment. To meet these requirements, FFDB researched and implemented a single use platform that provides manufacturing flexibility to meet client needs under accelerated timelines on a cost-effective basis. The presentation will include the process and product quality data for single use vs. stainless steel reactors that justified the cGMP expansion.
|
|
E-8
Language
13:00INTERPRETATION EJ | 14:00 |
The Future of Outsourcing: The CMO Perspective
Mr. Mike BrownVice President of Operations, Singapore Site Manager, Lonza Biologics Singapore Pte Ltd, Lonza Inc. When Lonza helped launch the CMO concept for the pharmaceutical market over 30 years ago, the market was, in relative terms, simple. Today, managing the supplier-client relationship, understanding the decision-making process, and overcoming inherent outsourcing challenges is vastly more complicated. This presentation will examine the key reasons pharmaceutical companies outsource and the new dynamics of customer relationship management. It will give insights into how Lonza has evolved to keep up with the needs of the outsourcing market as well as analyze the latest trends, make predictions about the future of outsourcing and give guidance on how suppliers and outsourcers can stay ahead of the curve.
|
|
E-9
Language
14:15INTERPRETATION EJ | 15:15 |
Catalent's GPEx™ Technology: cDNA to Stable-High Expressing Mammalian Cell Line in 4 Months and a 2-5 g/L Production in 6 Months
Dr. Gregory T. Bleck
 Senior Director of Cell Line Engineering and Research and Development Site Head, Catalent Pharma Solutions A rapid procedure for developing high expressing cell lines is critical for moving products efficiently from discovery into clinical trials. The GPEx™ technique for cell engineering allows production of genetically stable cells for any mammalian cell type without antibiotic selection or gene amplification. These cell lines have specific productivities up to 100 picograms/cell/day for antibodies and 90 picograms/cell/day for recombinant protein producing cell lines. Cell lines producing over 250 different molecules have been developed. Consistency, speed, stability and productivity data from these cells will be presented.
|
|
E-10
15:30| 16:15 |
Practical approach to protein expression by
GPEx™ technology of Catalent Pharma Solutions 
Ms. Chie KawaiChief Researcher, Toyobo Biologics Inc. Toyobo biologics Inc. provides a one-stop CMO service from cell bank establishment to cell cultivation in order to produce monoclonal antibody. Antibody drugs that are well-known for their high effectiveness and safety compared to other pharmaceuticals have been expanding in the recent market. However, one of the biggest tasks to overcome is to reduce the substantial cost on manufacturing. As it is well-recognized, various types of technologies to perform high titer of the protein are developing globally. In my presentation, I will introduce our examples by using a unique expression technology of GPEx™.
|
Biopharma Seminar (Vaccine)
March 23, Friday
|
H-9
10:30| 11:15 |
Inaugual Seminar
Development of peptide-based cancer vaccine 
Dr. Akira YamadaProfessor, Research Center for Innovative Cancer Therapy / Kurume University Two decades were past after the first identification of human cancer antigen. The era of non-specific immunotherapy against cancer, represented by "Maruyama vaccine", ended and development of new generation of cancer vaccines, that induce specific immunity, has been started in the world. In Japan, the first trial of peptide vaccine for cancer was started in 1999 by Kurume University and currently several groups including venture companies attend the development race of cancer vaccines. Current status and prospective of cancer vaccine development will be present.
|
|---|---|
|
E-12
Language
12:45INTERPRETATION EJ | 13:45 |
Inaugual Seminar
"FluBlok®" - advantage of a single propriety insect cell line to make all products
Mr. Daniel D. Adams
 Executive Chairman, Head of Business Development, Protein Sciences Corporation
Protein Sciences developed and patented a serum free insect cell line (expresSF+®) that was specifically designed for large scale manufacturing. It has a pipeline of vaccines that it developed and manufactures in this cell line, the most advanced of which is FluBlok, the first recombinant influenza vaccine made in cell culture, which is expecting FDA approval in months. FluBlok enjoys a myriad of advantages over influenza vaccines produced in eggs and mammalian cell culture including the lack of egg proteins or debris, high purity so that thimerosal and antibiotics are not needed, speed to market, low endotoxins and many others.
Protein Sciences also develops and manufactures prophylactic and therapeutic vaccines for human and veterinary use for many customers using its using expresSF+. Examples include Type 1 diabetes therapeutic vaccine (Phase 3), PCV vaccine for pigs (on the market worldwide) and many others. Developing and manufacturing all products in a single expresSF+ cell line has huge advantages compared to e.g. CHO cells. With regulatory approval of FluBlok, the cell line has become highly valuable because all issues regarding the cell line have been resolved and future vaccines will have an easier path to approval. |
|
E-14
Language
15:00INTERPRETATION EJ | 16:00 |
Development of Upstream and Downstream Manufacturing Process for Vaccines
Mr. Laurent REBIER
 Pharma, / Biopharma Market Expert, NOVASEP S.A.S.
Technology of Novasep Process regarding vaccine production will be introduced, including its past track record of experience.
Recombinant protein production using Insect Cells and BEVS will be discussed from both Upstream expression system to Downstream purification processing. |
Biopharma Seminar (Biocatalysis)
March 23, Friday
|
E-11
Language
10:30INTERPRETATION EJ | 11:30 |
Using Biocatalysis at Commercial Scale
Codexis has applied its DNA shuffling and protein engineering technologies to develop enzymes for large-scale commercial manufacturing. The two chiral intermediates for atorvastatin, the active ingredient in Lipitor®, are now manufactured at 100 mT per annum scale using four optimized enzymes, the key intermediates for boceprevir and telaprevir are manufactured at multi mT per annum using optimized monoamine oxidases, and sitagliptin, the active ingredient in Januvia®, will be manufactured using an optimized transaminase. The development of these enzymes and process and their overall impact on manufacturing will be discussed. |
|---|
Dr. Process Chemistry Seminars
March 21, Wednesday
|
F-1
11:00| 11:45 |
Development of efficient organic synthetic methods using heterogeneous platinum group catalyst and its application to process chemistry
Dr. Hironao SajikiProfessor, Laboratory of Organic Chemistry ,Gifu Pharmaceutical University A part of projects in our group aims to discover potentially-useful, efficient and industrially applicable functionalities of existing heterogeneous catalysts. We have developed some efficient chemical modification methods of aromatic compounds under mild conditions. For example, Rh/C or Ru/C-catalyzed hydrogenation of the aromatic nuclei and Pd/C-catalyzed removal reactions of halogen and hydroxyl functionalities on aromatic rings could be established as novel and applicable organic synthetic methods. I will release details on these methodologies and adaptability to process chemistry.
|
|---|---|
|
F-2
13:00| 13:45 |
Asymmetric Synthesis Achieved by Using Sugar Derivatives
Dr. Kin-ichi TadanoProfessor, Department of Applied chemistry, Keio University A variety of stereoselective carbon?carbon bond-forming reactions realized by the use of sugar-derived templates will be introduced. Some chiral templates, which are practically prepared from D-glucose, can serve as remarkably efficient stereocontrollers for 1) 1,4-conjugate additions, 2) ?-alkylations of esters, and 3) ???-dialkylation of 1,3-keto esters for the construction of an all-carbon asymmetric quaternary center. Some useful results on these asymmetric synthetic approaches will be summarized.
|
March 23, Friday
|
F-9
10:30| 11:15 |
Development of environmentally benign organic transformation reactions catalyzed by hypervalent iodine catalysts
Dr. Kazuaki IshiharaProfessor, Department of Chemical and Biological Engineering, Graduate School of Engineering, Nagoya University Here we report on several new hypervalent iodine catalyses: (1) the IBS-catalyzed oxidation of alcohols with Oxone, (2) the chiral iodosoarene-catalyzed enantioselective oxidative spirolactonization of 3-(1-hydroxynaphthalen-2-yl)propanoic acids with mCPBA, (3) the tetrabutylammonium hypoiodite-catalyzed ?-oxyacylation of aldehydes and ketones with carboxylic acids in the presence of TBHP, and (4) the chiral ammonium hypoiodite-catalyzed enantioselective cycloetherification of 3-(2-hydroxyphenyl)propan-1-one derivatives in the presence of TBHP or 30% aq. H2O2.
|
|---|---|
|
F-10
13:00| 13:45 |
Solkane® 365mfc: An Environmentally Benign Organic Solvent for Organic Synthesis
Dr. Norio ShibataProfessor, Department of Frontier Materials, Nagoya Institute of Technology Increasingly tighter restriction on the use of organic solvents in industrial synthesis led us to search for an environmentally benign alternative solvent for the organic reactions. Although solvent-free conditions seem to be suitable for green chemistry, in most cases, a solvent is often required to assist in working-up processes and transporting of materials. The use of ionic liquids as alternative reaction media for organic chemistry is another solution. In this presentation, we report that a hydrofluorocarbon, Solkane® 365mfc (1,1,1,3,3-pentafluorobutane) is a potentially useful alternative solvent for variety of organic reactions.
|
|
F-11
14:00| 14:45 |
Process Chemistry for Unnatural Amino Acids
Dr. Masaru MitsudaSenior Researcher, Frontier Biochemical & Medical Research Laboratories, Kaneka Corporation Unnatural amino acids have been fully recognized as very important components for modern small molecular drug discovery. In fact, many drug candidates which contain structural peculiar unnatural amino acids are going on to the development stage today. Therefore, a variety of new technologies for an efficient, scalable and highly stereoselective synthesis of unnatural amino acid derivative are desired to be provided from a standpoint of process chemistry. The speaker would discuss some useful technologies and recent applications for non-racemic unnatural amino acid productions.
|
|
F-12
15:00| 15:45 |
Development of material production process using high-pressure and high-temperature microreactor
Dr. KawanamiSenior Researcher, Research Center for Compact Chemical System,National Institute of Advanced Science and Technology Water has unique physical properties under high-pressure and high-temperature conditions. However, water has a good potential as a conventional solvent for organic reactions, there are few reports to be succeeded. Recently, we have developed the high-pressure and high-temperature microreactors and achieved the flow reaction system for variety of organic reactions with high conversion and high selectivity within a very short time. At this lecture, I will introduce our principle strategy and show some examples in high-pressure and high-temperature water.
|
The Society of Lodine Science Seminar
March 23, Friday
|
H-10
11:30| 12:15 |
Advanced application of iodine
Dr. Tatsuo KaihoDeputy Director, Kanto Natural Gas Development Co., Ltd. (Society of Iodine Science) Japan is the world's second largest producer of iodine after Chile. Iodine is unique resources in Japan, which has scarce natural resources. Iodine compounds are used in many areas such as biocides and X-ray contrast media. Recently, new hypervalent iodine compounds have been developed as recyclable oxidizing agents and rare metal substitute catalysts. In this seminar novel applications of iodine will be presented.
|
|---|
Group Presentations
March 21, Wednesday
|
F-3
Language
14:00INTERPRETATION EJ | 15:00 |
Leading edge technology from UK
14:00-14:20 Targeted delivery using hard shell capsule technology Ms. Rosaleen McGuckin, Encap Drug Delivery 14:20-14:40 International licensing of generic and over-the-counter products Mr. Asa Cox, Generic Pharma 2.0 14:40-15:00 Solid State Expertise in Pharmaceutical Development Mr. Stephen Watt, Solid Form Solutions Ltd |
|---|
A Practical Guideline to the Revised Pharmaceutical Affairs Law: Answers to all your questions about Japan’s Pharmaceutical Affairs Law
March 22, Thursday
|
H-5
Language
10:30INTERPRETATION JE | 12:00 |
A Practical Guideline to the Revised Pharmaceutical Affairs Law: A special workshop for English speaking exhibitors & visitors
Answers to all your questions about Japan's Pharmaceutical Affairs Law
Mr. Tamiji Nakanishi
Deputy Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Mr. Tsuyoshi Matsuno
Deputy Director, Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare
Mr. Tamotsu Fujino
Director of International Affairs Department, Japan Generic Medicines Association
Mr. Shohei Ishizaki
Japan Pharmaceutical Traders' Association (Manager, Pharmaceutical Regulatory Affairs Office, Fine Chemicals Dept., Nagase & Co.,Ltd.)
This workshop is being repeated again this year following the highly favourable feedback we received at the previous show. Panelists from the Ministry of Health, Labour and Welfare, the Japan Generic Medicines Association and the Japan Pharmaceutical Traders Association will respond to your questions about the law such as the maintenance of Master File System for drug substances, the renewal procedures for Accreditation of foreign manufacturers, the application for GMP Compliance Inspection for foreign manufacturers, etc. Our panel of experts will provide you with practical advice and guidance. This will be a great opportunity for you to make all your questions clear, so don't miss it!
*A questionnaire will be sent to registered participants to collect your questions or comments of difficulties you have encountered in complying with the law, so please feel free to inform us what you want to know about the law before you attending this workshop. |
|---|
Business Seminar
March 21, Wednesday
|
H-3
Language
15:00INTERPRETATION EJ | 17:00 |
India-Japan: Emerging Co-operation in Pharma and Healthcare Sector
  
Date & Time: 15:15-17:00 21.March 2012
Venue: Conference Room, Hall No.5 Jointly Organized by PHARMEXCIL & India Japan Pharma Alliance (IJPA)
|
|---|
