Exhibit Floorplan update Grand Ballroom ABCD
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1 Exhibit Floorplan update Grand Ballroom ABCD Booth # Company/Organization 100 Lonza Walkersville, Inc. 101 Compass Biomedical 102 stemtrak Biosafe America, Inc. 105 Waisman Biomanufacturing General Sessions PeproTech, Inc. 109 Immudex 200 Title21 Software 201 Corning Life Sciences 202 JAF Consulting, Inc STEMCELL Technologies Inc. 204 Mill Creek Life Sciences STEMSOFT Software Inc. 206 Mediware Information Systems, Inc. 207 Digi-Trax Corporation 208 Amega Scientific Corporation General Sessions Akron Biotech 301 ThermoGenesis Corp 302 Fenwal, A Fresenius Kabi Company , 305 GE Healthcare 304 MAK-System Corp 306 Macopharma USA 400 Irvine Scientific Booth Miltenyi Biotec 405, 407 BioSpherix, Ltd. 408 Terumo BCT Macopharma is a leading worldwide manufacturer of medical devices for transfusion, infusion and biotherapy. Within the field of blood processing Macopharma with its extensive experience offers innovative solutions from blood collection through component processing to patient transfusion. exhibit floorplan Update Investments in research and development as well as partnerships with blood centers, universities and biotechnology companies enable Macopharma to provide inventive solutions for pathogen reduction as well as for the expanding field of cell therapy.
2 CORPORATE TUTORIAL HOSTED BY Monday September 9, :15pm 1:15pm Columbus A CELL THERAPY MANUFACTURING: PRE-CLINICAL, CLINICAL, AND COMMERCIAL SCALE Speaker: Jim Beltzer, PhD, Terumo BCT Cell therapy holds great therapeutic promise in an almost unlimited number of indications. Most cell therapies are in pre-clinical or phase 1 2 clinical trials. The next stage in the development of the cell therapy industry will be the scale up required to deliver cells for phase 3 clinical testing and ultimately commercialization. A number of case studies will be presented to describe the transition from laboratory development to market launch. Key to this process will be cell characterization, scale up considerations, and cost containment. CORPORATE TUTORIAL
3 EXHIBITOR DIRECTORY BOOTH #300 BOOTH #104 Akron Biotech was founded in 2006, and is a privately owned company headquartered in the United States. Akron has a strategic focus on enabling tools, technologies, and services for the regenerative medicine industry. As a global supplier, Akron manufactures and distributes components and raw materials for cell therapy discovery, development, and commercialization, meeting the industry s needs worldwide. Our company s unique business model emphasizes flexibility, quality, and unparalleled service- from research and development through clinical trial, market authorization, and commercial product. We are set up to comply with cgmp, cglp, USDA, FDA, CFR, and HIPPA regulations and standards. Our U.S. manufacturing facility is ISO 9001 certified. We provide regulation-approved raw materials (USP, EP, and JP grades) and biological reagents, from research grade to cgmp grade. Biosafe develops, manufactures and supplies innovative solutions for cell processing in both adult stem cell banking and regenerative medicine. The Sepax cell processing technology has been adopted for leading clinical research studies, particularly for cardio-vascular, orthopedic, and transplantation applications. Its fully integrated design and compact size makes it especially suitable for use at the point-of-care or in a confined laboratory. The Sepax system is also the industry standard in automated adult stem cell processing and the preferred technology for a large majority of the world s public and private cord blood banks. Sepax provides the user with the necessary flexibility through a combination of application-specific software protocols and single-use kits. BOOTHS #405 AND 407 BOOTH 208 Amega Scientific Corporation s AmegaView centralized monitoring and alarm system monitors your units, logs and archives data, and notifies you of alarm conditions instantaneously. This centralized monitoring system is easy to use, saves you time and money, and streamlines work flow to create a productive working environment while meeting industry regulatory requirements. Your data can be accessed from any PC or iphone on the network for purposes of report, review, analysis and programming. The AmegaView System can alert the user by one or more of the following methods: local alarms, PC alarms, phones, s, text messages, and / or audio visual alarms. BioSpherix will be exhibiting the Xvivo System, world s first and only barrier isolator optimized for cells. Economical and practical alternative to cleanrooms for cgmp compliant production of human cells for clinical use. Get better contamination control, better process control, better quality control, better pocketbook control. Stop by the BioSpherix booth. BOOTH #101 Compass biomedical Compass Biomedical An Arteriocyte Company Translational Research Tools for Cell Culture and Expansion Compass Biomedical provides novel products and technologies for translational research in cell therapy. Our core technology includes the biofunctional nanofiber-based surface, NANEX that promotes in-vivo like cell growth while
4 minimizing loss in stem cell phenotype. Our NANEX Cell Culture and Expansion Kit has been designed specifically for ex vivo expansion of human bone marrow, peripheral blood, and umbilical cord blood derived HSCs/HPCs. Adhere-34 is our advanced cell culture bag that incorporates our NANEX technology into a fully enclosed system. Adhere-34 provides the ability to seamlessly transition from the research grade NANEX to a closed culture system better suited for use in clinical protocols. Our PLUS Cell Culture Supplement is a human-derived, cytokine rich replacement for fetal bovine serum (FBS). PLUS is prepared from human platelet lysate using state of the art manufacturing techniques. PLUS enhances growth and phenotype retention of human derived stem cells such as mesenchymal stem cells. (cellular therapy) systems and HemaTrax (blood bank) have been installed in thousands of facilities worldwide. Providing consultation since the first ISBT 128 Task Force, Digi-Trax has been instrumental in the development of ISBT 128 standards for cellular therapy. We maintain a close working relationship with ICCBBA and participate on their committees to positively influence the direction of cellular therapy labeling. Our proprietary software conforms to the most recent ICCBBA guidelines and our labels meet all appropriate FDA regulatory requirements. BOOTH #302 BOOTH #201 Corning offers an industry-leading line of advanced cell culture surfaces, scalable vessel platforms, and media services that provide enabling solutions for cell therapy researchers. Corning s family of cell culture vessels including flasks, roller bottles, CellSTACK and HYPERStack vessels, and the CellCube perfusion system. Choose the newly introduced, ready-to-use Microcarriers for increased surface needs. Coupled with an extensive line of both vialed and pre-coated extracellular matrices from the established Matrigel matrix to defined animal-free ECM mimetic substrates and surfaces Corning provides scalable cell culture environments for stem and primary cell types with clinical potential. Corning cellgro media solutions include standard and custom cgmp media as well as basal salt solutions, antibiotics, sera, and single-use systems. Built upon a foundation of innovation and manufacturing excellence, count on Corning for consistent, reliable, repeatable results. BOOTH #207 Fenwal is a global blood technology company dedicated to supporting transfusion medicine and cell therapies. We help ensure the availability, safety, and effectiveness of treatments that depend on blood medicine s most vital natural resource. Fenwal is a Fresenius Kabi company. BRONZE SUPPORTER BOOTHS #303 AND 305 The Cell Bioprocessing business of GE Healthcare aims to be a leading provider of cell therapy tools that will decrease costs, increase accessibility and improve quality in an overall effort to facilitate the adoption of cell therapy. GE Healthcare works with key organizations and projects providing products to help meet immediate needs, as well as a combination of innovative hardware engineering, design, integration and production capabilities for the future. Digi-Trax Corporation is a leading provider of ISBT 128 bar code compliance labeling software, hardware, labels and supplies for cellular therapy facilities, blood banks, transfusion services and laboratories. Our HemaTrax -CT
5 BOOTH #109 BOOTH #202 Based in Copenhagen, Denmark, with North American operations based in Fairfax, Virginia, Immudex provides MHC Dextramers for the monitoring of antigen-specific T cells. Under an agreement with the US Cancer Immunotherapy Consortium (CIC) and the European Cancer Immunotherapy Consortium (CIMT), Immudex also provides MHC Multimer and Elispot proficiency panel services worldwide. Immudex s MHC Dextramer products are utilized for the quantification or sorting of antigen-specific T cells in life science research, in vitro diagnostics, as well as the development of immunotherapeutics and vaccines. The primary focus is research-use-only products for the immune monitoring of immunotherapy development, and monitoring of CMV cellular immunity in transplant and other immune-deficient patients. In Europe, the CE-marked Dextramer CMV Kit is approved for in vitro diagnostic use, for the quantification of CMV-specific T cells. To learn more about proficiency panel participation proficiencypanel@immudex.com *The Immudex CMV kit is for Research Use Only in the United States BOOTH #400 Irvine Scientific, a member of JX group, is a worldwide leader in the design, manufacture and distribution of medical devices, including Industrial Cell Culture, Cell Therapy, Cytogenetic, and Assisted Reproductive Technology (ART) products. Irvine Scientific is a worldwide media provider that is regulated and adheres to both ISO and FDA regulations with dual manufacturing facilities in California, USA and Tokyo, Japan. Irvine Scientific is a large scale producer of advanced quality cell culture media for the industrial bioprocess, medical, and diagnostic markets. The company s extensive experience in the design of culture media, compliance with ISO and FDA regulations for class II / III medical devices, industrial scale manufacturing capacity, provides its customers with unique capabilities and support. JAF Consulting, Inc. specializes in the Management and Execution of Computer System Implementation Projects in Regulated Industries. Our consultants are renowned for their practical understanding and cost effective approaches while assisting clients in complying with today s regulatory requirements for the System s entire Life Cycle. JAF s services include: Compliance Program Planning, Project Management & Execution, CSV Training, 21 CFR Part 11, and Compliance Auditing & Assessment Services. BRONZE SUPPORTER BOOTH #100 Lonza offers world class technology platforms in the areas of GMP cell culture and viral-based therapeutic manufacturing, a full line of custom bioassays, and a large selection of primary and stem cells. Our extensive experience in cell therapy process optimization and scale-up innovation helps clients to safely and effectively advance their products through all phases of the commercial pipeline and maximize their return on investment. Our Viral-based Therapeutics group provides viral vaccine manufacturing as well as viral vector mediated gene therapies for the treatment of infectious diseases, neurological disorders, cancer and cardiovascular diseases. From early development through commercial launch and mature market supply our staff can design, develop, and implement a manufacturing process that meets your autologous or allogeneic therapeutic applications. For more information, visit: or contact celltherapy@lonza.com
6 BOOTH #206 BOOTH #401 Mediware is a leading provider of specialized healthcare solutions with over four decades of experience developing and delivering innovative software designed to ensure the highest level of safety and efficiency. The Transtem software makes it easier to manage data associated with the collection and processing of therapeutic stem cells. With this comprehensive system, you can efficiently manage donor, clinician, product and recipient data all in one place exactly how it should be. Developed using firsthand experience gleaned over years of work in cellular therapy, Transtem not only supports and streamlines the needs of laboratory staffers and clinicians, and it has the unique ability to provide a comprehensive cell therapy solution that spans from donors, to care givers, patients and families. Mediware also offers software for cord blood banks and BMT labs as well as cancer treatment centers and research facilities along with blood management software for hospitals and blood centers. BOOTH #204 Mill Creek Life Sciences, located in Rochester, Minnesota, produces a media supplement to grow stem cells, PLTMax. PLTMax is a natural media supplement derived from human platelets, offering un-paralleled stem cell growth. Cells grow at half the concentration of FBS and double in half the time. PLTMax is available in both clinical and research grades; currently being used in multiple clinical trials from Phase I to Phase III. PLTMax covering your needs from bench to bedside. Miltenyi Biotec provides MACS Technology, the gold standard in cell separation for research and clinical scale, as well as sample preparation, cell analysis and molecular biology products and services to the biomedical research community. The company also manufactures cgmp custom reagents, antibodies, proteins, peptides, and other molecules. BOOTH #106 We are pleased to announce that 2013 marks our 25th year in business. Supporting Life Science Research since 1988, PeproTech is the trusted source for the developing and manufacturing of high quality cytokine products for the lifescience and cell therapy market. Over the past 25 years the company has grown into a global enterprise with state-of-the-art manufacturing facilities in the US, and offices around the world. With over 2,000 products PeproTech has developed and refined innovated protocols to ensure quality, reliability and consistency. Our mission is to provide the highest quality products and premium support that address the needs and demands of today s scientists and researchers. We pride ourselves on being a trusted partner within the scientific community. Comprehensive line of Cytokines and Antibodies GMP-Compliant products for Cell, Gene and Tissue Therapy Animal Free Cytokine Range ELISA kits Media Kits / Supplements
7 BOOTH #304 Since 1984, MAK-SYSTEM International Group has specialized in designing innovative software that delivers superior functionality to Cell Therapy Labs, Cord Blood Banks, Blood Banks, Plasma Centers, Transfusion Services and Tissue Banks. With more than 1200 software installation in 60 countries, MAK-SYSTEM is uniquely qualified to provide services with the most comprehensive combination of software functionality, services and technology solutions to safeguard and optimize your process. product traceability, generate required labels including ISBT 128 and assist with overall regulatory and accreditation compliance needs such as FACT. Visit STEMSOFT at booth #205 to learn more. STEMSOFT Software Inc. Track Share Grow BOOTH #102 BOOTH #203 STEMCELL Technologies is a leader in the development of specialty cell culture media, cell isolation products and ancillary reagents for cell therapy research. Driven by science and a passion for quality, STEMCELL Technologies delivers over 1500 products to more than 70 countries worldwide. STEMCELL Technologies offers products for the enrichment, expansion and differentiation of a variety of stem and progenitor cells. StemSpan SFEM II is a new medium for robust expansion of CD34 + human cord blood and bone marrow cells. StemSpan ACF is the first commercial, animal component-free human hematopoietic cell expansion medium. MethoCult is the gold standard in methylcellulose-based media for detection of hematopoietic progenitors in the colony-forming unit (CFU) assay. MesenCult -XF is a serum- and xeno-free medium optimized for the expansion of mesenchymal stem cells, as well as their enumeration using the CFU-F assay. To learn more about how STEMCELL Technologies facilitates life science research, please visit BOOTH #205 STEMSOFT is the leading provider of software solutions that are created, designed and maintained for the specific and unique needs of the cellular therapy community. STEMSOFT offers a complete range of integrated solutions that are designed to save time, increase quality control, track complete stemtrak provides configurable, web-based, data management software solutions that enable Stem Cell Transplant Programs and Cord Blood Centers to optimize their processes and centralize their data while eliminating errors, variance, and duplicative data entry. Our solutions empower physicians, health care professionals, and data managers to easily access critical program data in an intuitive user-friendly interface. stemtrak gives users an unparalleled ability to quickly and easily perform statistical analysis, respond to RFIs, and interface with NMDP, CIBMTR, and other agencies that require information from the Center. Our solutions provide flexibility and configurability while being fully compliant with and all Health Information Privacy rules and regulatory requirements established by the FDA. stemtrak has a profound knowledge of technology, patient care practices, and implementing software solutions in regulatory environments. Using this knowledge, stemtrak works with its clients to implement solutions that meet their requirements while exceeding their expectations. BRONZE SUPPORTER BOOTH #408 Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. Terumo BCT Unlocking the Potential of Blood.
8 BOOTH #301 BOOTH #105 ThermoGenesis Corp, the market leader in stem cell processing and cryopreservation solutions, will show case: AutoXpress Platform, including AXP System and MXP System, defines a new processing standard for concentrating stem cells from cord blood or bone marrow samples in a fully closed sterile system. The platform offers superior MNC recoveries and labour savings. The BioArchive System, the state of the art robotic cryopreservation system, provides the best protection for today s valuable stem cell samples that meet tomorrow s stem cell therapy needs. Res-Q TM 60 BMC, a point-of-care system, designed to provide high-quality cell concentrates easily, consistently, and reliably from bone marrow aspirates and to simplify the entire concentration process with minimal human interface. BOOTH #200 Waisman Biomanufacturing has in-depth experience in manufacturing a wide range of biotherapeutics for human clinical trials including gene therapeutics, cell therapeutics, vaccines, and recombinant proteins. Waisman has developed platform manufacturing processes and analytical methods to support clinical production of several classes of biotherapeutics including plasmid DNA, Mesenchymal Stromal Cells (MSCs), pluripotent stem cells (hescs, ipscs), neural progenitor cells, adenoviral vectors, and lentiviral vectors. We can provide four key components for cellular therapies: providing reprogramming vectors (EBV plasmids), sourcing human cells in compliance with regulations for HCT/Ps, Tissues, and Cellular and Tissue- Based Products (21 CFR 1271), producing cell banks under cgmps, and production of final cell therapeutics including differentiated cell types. Waisman provides full support for IND filings by providing QA audited batch records and support for your Investigational New Drug (IND) filing including Chemistry, Manufacturing, and Control (CMC) support and access to the Waisman Biomanufacturing Type V Facility Master File. Title21 Software is a provider of electronic solutions that streamline the core clinical and laboratory processes of cellular therapy labs while closing compliance gaps, increasing efficiency and driving success. Since 2001, Title21 has offered innovative solutions to automate limitless workflows, manage patient data, and support the overall quality of your program, all in one comprehensive platform. Title21 s technology enables your organization to capture, manage, trend, track and report on your entire patient and process data as well as manage the operational functions of your program such as training management and inventory management. Title21 supports your lab in becoming more inspection-ready while simplifying accreditation processes such as FACT and AABB. All Title21 modules support regulations including 21CFR part 11 & 1271, CIBMTR upload via AGNIS, and ISBT 128 compliant label printing. T21 products combine configurability, adaptability and integration, enabling your organization to elevate the overall quality and efficiency of your program.
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