CBV Leiden produces the biologic products Remicade, Reopro as well as new commercial products. The Production Planning department scheduled shop floor processes using Excel based planning tools, which usually lagged the actual situation. This resulted in supply and demand variability in production processes, as well as a lack of visibility, and departments operating in a disconnected manner from their suppliers and customers. The consequences of this were the loss of capacity and missed opportunities to deliver more products through the supply chain. Therefore, a totally visual system of production control boards was implemented. These boards show the production plan, where to find products, production status, and inventory. They were designed using the Lean concepts of pull, visual management and 5S. This system has resulted in less schedule variation, an 85% reduction in time searching for materials and an average capacity increase of about 10%.

Securing supply at all times is at the core of our industry. Providing the necessary manufacturing capacity in advance requires high risk large capital investments with long lead times. In the context of increasing uncertainty about the future demand, Merck Serono approaches this challenge with a balanced approach. For existing operations, we strive to increase our capacity with a continuous improvement process in manufacturing and process development to free resources to build capacity for new processes and products. In one case, productivity rose by 70% within four years. This reduced unit costs by 40% and avoided the risk and cost of transferring the process into a large scale process. The resulting financial benefit is twofold with savings both in capital investment and operating expenditures.

Bigger is not Always Better: How Optimization is replacing Maximization in Biologics Production Driven by changes in market condition, cost pressure, regulatory conditions, follow on biologics, and the political climate, most successful biotechnology companies are going through a major transformation. Whereas in the past, companies were actively seeking to maximize their production capacity, the new trend in biologics manufacturing is that of optimizing production. In the presentation, we will start by briefly reviewing the evolution of biologics production and how the industry managed to meet customer expectation through maximizing production capacity. The pros and cons of maximize vs. optimize will be covered focusing on the overall strategic superiority of optimization. Hence, the objective of the transformation is to become a nimble production facility capable of meeting the variation in customer demand. Practical examples on solutions emphasizing optimization will be presented along with a hypothesis for what the future may hold in biologics production. Dr. Fadel Hamed PROP Operational Excellence An effective problem solver with an extensive background in process improvement, lean, and six sigma. Fadel has more than 12 years of experience in multiple industries including semiconductor, fiberoptics, and now biotechnology. Prior to joining Genentech, Fadel worked at Amgen, IBM, and Lambda Optics. Fadel’s background combines skills in operations, manufacturing , quality, technical management, and strong leadership. He is a frequently requested speaker at International conferences. Fadel holds a doctorate in mechanical engineering from UC Berkeley and he is an ASQ certified six sigma black belt and quality engineer.

There are two major roles for the process development at Wyeth: manufacturing support and productivities improvement. Due to the complexities of producing biological drug substance material on a large manufacturing scale, any unanticipated minor process changes (physical or chemical) might compromise cell culture performance. Case studies on how such process changes have affected the manufacturing performance and how process development addresses and controls these changes will be discussed. Because of the high cost of building manufacturing facilities biopharmaceutical companies have realized that the best way to meet increased capacity demands is through continuous process improvements to achieve higher yielding processes instead of building additional facilities. This presentation shows how the process development group achieves high productivity cell culture processes and the effect on manufacturing strategies.

Emile van Corven, Director Process Development at Crucell, has more than 15 years process development experience covering recombinant proteins, antibodies and viral vaccines. His presentation will describe the development status of an efficient market scale manufacturing process for a recombinant adenovirus (rAd) based tuberculosis vaccine produced on PER.C6® cells, currently in Phase I clinical trials. To meet the global tuberculosis vaccine market demands of 100-200 million doses after licensure, at least 15 batches at 10,000L scale will be required. To decrease Cost of Goods and avoid early investments in a large scale GMP facility, the focus is on a 5-10 fold intensification of the bioreactor process to be realised through increases in both unit and volumetric productivities. This work will likely provide additional insights into the propagation of eukaryotic viruses in PER.C6® cells and reveal attributes in addition to growth to high cell density under serum free conditions which position PER.C6® as an attractive cell substrate for 2nd generations of vaccines which are currently propagated with serum containing media on cell substrate dependent cell lines.

Dr Chidwick, Pharmaceutical assessor, MHRA will discuss the likely quality requirements that may be required

With the advent of new generation biomolecules as therapeutics, the requirement to demonstrate the consistent quality, purity and efficacy of potent proteins is essential. Whilst older analytical techniques have continued in use, new technologies have also been developed to use as routine analytical tools. These have resulted in high-definition quality specifications for therapeutic proteins based upon the ability of the techniques to examine molecular properties in ever-increasing detail. New techniques will be reviewed as applied to the analysis of complex and highly potent biological products.

Recent developments in the competitive and regulatory landscape for pharmaceutical and biotechnology manufacturing are driving the implementation of systems needed to enable Quality by Design and achieve a higher standard of global manufacturing excellence and predictability. Existing data systems must be fully leveraged so that end users can deepen their understanding of complex processes in real time using continuous (on-line), discrete (off-line) and replicate data to identify and reduce sources of process variability. This workshop will discuss how to provide an on-demand data access, aggregation and analytics platform across the global manufacturing network that puts an end to “spreadsheet madness” and goes to the next level beyond dashboards and canned reports. Multi-disciplinary technical teams use this platform collaboratively to improve process predictability using traditional and new kinds of ad hoc cause-and-effect analysis, as well as capabilities for current and periodic reports (e.g. Trending, APRs) all integrated into the same validated environment.

As the Head Production at the Novartis biopharmaceutical site of Huningue (France), Leopold is responsible for all cell culture, purification, planning, logistics & purchasing operations of the manufactured drug substance at the Novartis site. His current responsibilities involve management of all start-up and production activities related to drug substance manufacturing. Leopold coordinated the transfer of the Xolair purification process from Genentech on the Novartis side between 2000-04, and is currently leading the Novartis team in the Xolair manufacturing and logistics joint committee. In 2008, his team conducted the switch of the plant from dedicated to multi-product and successfully transferred a new late clinical phase MAB to the Huningue site. His former experience includes (bio)catalysis, biotech process development and production, commercial manufacturing of synthetic active drug substances, and technical due diligence. He holds a chemical engineering Ph.D. from ETH Zürich (Switzerland), and started at Ciba (a Novartis founder company) in 1993. Leopold is active member of the EBE (European Biotech Enterprises) Bio-manufacturing Working group.

Sharon worked within clinical trials at Guys Hospital in London prior to taking up a research position at Celltech. Sharon subsequently moved to Celltech's manufacturing business, and held various management positions within contract manufacturing. Following this, Sharon moved to Project Management, and managed preclinical and clinical development programmes at Celltech for both new chemical entities and new biological entities. Following the mergers of Celltech with Chiroscience and Medeva, Sharon became Head of Biologics Manufacturing Development, and was responsible for the delivery of biological products from the preclinical stage to market launch. From 2002 - 2004, Sharon was Director of Westerly Projects Ltd, a consultancy company offering development services to the biopharmaceutical industry globally. Sharon joined Antisoma in 2004 as Director of Project Management and Manufacturing, and has responsibility for CMC activities and project and portfolio management. In addition, Sharon has chaired the Manufacturing Advisory Committee for the BIA since 2003

The manufacture of diagnostic monoclonal antibodies requires low cost preparation of multiple products at the highest quality. The use of lean principles and the application of disposable systems will be considered in the manufacture of over 250 batches per year from an 85 cell line product range. Advantages and disadvantages, including method development, validation and process transfer will be reviewed. A cost benefit analysis of moving towards disposables within an established FDA regulated facility will be discussed.

Dr. Arunakumari is Senior Director of Process Development at Medarex, the worldwide developer of human antibody therapeutics. In her role, she oversees the development and transfer of cell culture and purification processes to internal manufacturing in addition to outside CMOs. Her extensive 15-year experience in different management roles at Bristol Myers-Squibb, Enzon and Medarex, have been instrumental in integrating upstream and downstream processes and achieving 5 g/l in productivity. She significantly improved over all facility output and batch processing time by developing simple non-protein A purification processes in fewer processing steps and column cycles. Her technique not only optimised conditions to remove all process related contaminants on ion exchange resin comparable to that of affinity chromatography, but also modified the process schemes to require less validation. These groundbreaking projects were carried out simultaneous to a pipeline project in process development and managed to scale up ‘ion exchange-processes’ to handle up to 5000 liters of cell culture harvest. Alahari’s critical contribution to Medarex platform technology produced 12 different humabs between the manufacturing facility and Contract Manufacturing Organisations.

NIRS is a technique very well suited for the analysis of lyophilized formulations. It can be used for several different purposes, such as identification of excipients, active components and polymorphs, detection of changes or differences in the quality of excipients and active components, differentiation of surface and bound water, investigation of molecular interactions and secondary structure of proteins, determination of moisture and crystallinity. The probably most important application for the development of lyophilized formulations is moisture determination. The strong water absorption bands in the near infrared spectrum, the rapid and non-destructive nature and the possibility to make measurement through glass walls, makes NIRS ideally suited for moisture assays of lyophiles.

The road to delivery of human embryo stem cell derived therapies P.A. De Sousa 1,2, A. Courtney 2, M. Turner 1,3, University of Edinburgh 1, Edinburgh, Scotland, UK; Roslin Cells Ltd 2, Roslin Biocentre, Midlothian, Scotland, UK; Scottish National Blood Transfusion Service 3, Edinburgh, Scotland, UK. Realising the therapeutic promise of human embryo stem cells (hESCs) necessitates overcoming diverse challenges. This begins with meeting the legal and ethical challenges of procuring embryos. Next, the efficacy of in vitro culture systems supporting cells must be improved using reagents whose specification complies with regulatory standards. This is followed by qualification of resulting cells and assessment of their bio-safety both in relation to the prospective transplant recipient and the community at large. Complicating the address of these challenges are constantly evolving and internationally variant regulatory standards which have the capacity to negate the utility of cells for emerging therapies before clinical trials are even begun. To address the aforementioned interdisciplinary challenges Roslin Cells Ltd (RC) was established in 2006 as a not-for-profit company owned by the University of Edinburgh (UoE), the Scottish National Blood Transfusion Service (SNBTS) and the Roslin Institute. It is core funded by Scottish Enterprise which recognised the market failure defined by a lack of industrial investment in a promising yet unproven technology and limited research council support for translational research. Similarly to other UK centres attempting to derive hESCs, RC is licensed by the Human Fertilisation & Embryology Authority (HFEA). In addition it is the first centre to be licensed by the Human Tissue Authority for the processing, testing, storage, distribution, and export/import of embryos and stem cells intended for human application. It has developed and implemented a quality management system specifically designed for hESC derivation based on that used by the SNBTS. In addition to improving its capability to derive new lines and implement cGMP compliant procedures, RCs’ three major areas of development are i) the identification and validation of xeno-free cGMP grade reagents, cGMP feeder cells and other cGMP compliant matrices, ii) the development and validation of assays for the quality control tests which are essential for the subsequent release of cGMP compliant hESC lines and iii) the development of effective and compliant cryopreservation technologies. Looking forward, it is intended that RC will operate within the translational facility of the new UoE MRC-Centre for Regenerative Medicine due to be completed in 2010.

Regenerative medicine is an exciting new area that holds the promise to treat a variety of chronic conditions by actually causing the body to regenerate lost tissue or organs. The Joint Commission for Health Care Organizations (JCAHO) recently declared the shortage of transplantable organs and tissues a public health crisis. There is about one death every 30 seconds due to organ failure and it has been estimated that the cost, just in the U.S., of caring for persons who might benefit from Regenerative Medicinal products has reached $600 billion annually. The first products are already on the market and there are many more in the clinic or laboratory stages of development. Often these products are composed either solely or in part from living human cells and the manufacture and supply chain of such products has been an enormous challenge to the fledgling industry. This talk will concentrate on current status, lessons learned and the possible future of this new area of manufacturing where the cell is not the source of the biological product but the product itself.

The economic benefits of single-use products are substantial because they are now more accepted technically in bioprocessing production. The modeling systems are intended to address key areas of concern. Also to assess the direct and indirect benefits and give simple but customer-specific guidance. Process modeling systems which cover the whole manufacturing flow are also discussed. Manufacturers are applying an increasing number of qualification criteria to their production culture media and process supplements. They now specify SFM and strongly recommend animal component-free materials. Recombinant and plant-derived proteins and hydrolysates are currently acceptable, whereas the demand for completely chemically defined formulations is growing. Defined media support the many initiatives, including reduction in material lot-to-lot and common cause variability, and facilitating process verification and understanding.

UNOsphere S and RS are two versions of sulfonyl-type cation exchange resins with uniquely different properties. UNOsphere RS equilibrates rapidly, is extremely base-stable, has high binding capacity and possesses good flow rate properties. UNOsphere S is similar to UNOsphere RS but contains significantly more carboxyl groups in the matrix backbone. The presence of these groups allows the resin to internally and reproducibly generate linear and/or step pH gradients, avoiding the traditional requirement for pre-column buffer blending; all that is required is equilibration in one buffer followed by a step transition to an appropriate second solution. The use of such gradients to separate protein species with extremely close pI values, in a low-conductivity system, will be explored.

The economic benefits of single-use products are substantial because they are now more accepted technically in bioprocessing production. The modeling systems are intended to address key areas of concern. Also to assess the direct and indirect benefits and give simple but customer-specific guidance. Process modeling systems which cover the whole manufacturing flow are also discussed. Manufacturers are applying an increasing number of qualification criteria to their production culture media and process supplements. They now specify SFM and strongly recommend animal component-free materials. Recombinant and plant-derived proteins and hydrolysates are currently acceptable, whereas the demand for completely chemically defined formulations is growing. Defined media support the many initiatives, including reduction in material lot-to-lot and common cause variability, and facilitating process verification and understanding.

The use of high throughput (HT) technologies in process development has held an allure for many years. Whilst these technologies can significantly decrease timelines and increase probabilities of success, they are not without cost and limitations. Success depends on understanding realities such as (1) time upfront to test the capabilities and limitations of the instruments, (2) the addition of any technology will affect upstream and downstream workflows and (3) a data management plan and tools are required. This workshop will explore examples of HT technologies integrated in relevant workflows.

High numbers of projects coming through development, flexibility for multiple products in manufacturing, and avoiding capital expenditure on new facilities are top priorities in a maturing biopharma business. Three studies will be presented: high throughput process development in designing chromatographic purification, ready-to-process equipment in LEAN approaches for clinical manufacturing, and automated large-scale column management responding to results from a LEAN analysis of change-over procedures. Process improvement options will be discussed in a global benchmarking study of industry performance.

Recent developments in the competitive and regulatory landscape for pharmaceutical and biotechnology manufacturing are driving the implementation of systems needed to enable Quality by Design and achieve a higher standard of global manufacturing excellence and predictability. Existing data systems must be fully leveraged so that end users can deepen their understanding of complex processes in real time using continuous (on-line), discrete (off-line) and replicate data to identify and reduce sources of process variability. This workshop will discuss how to provide an on-demand data access, aggregation and analytics platform across the global manufacturing network that puts an end to “spreadsheet madness” and goes to the next level beyond dashboards and canned reports. Multi-disciplinary technical teams use this platform collaboratively to improve process predictability using traditional and new kinds of ad hoc cause-and-effect analysis, as well as capabilities for current and periodic reports (e.g. Trending, APRs) all integrated into the same validated environment.

Is purification of greater protein mass, from higher fermentation titers, causing you to exceed your downstream production facilities tank capacity? ChromaSorb™ solution is a disposable flow through anionic membrane adsorber, designed to replace the anion exchange column in a traditional chromatography polishing template. Data from MAb feedstocks shows that ChromaSorb™ can reliably achieve the following purity targets from cation pools: HCP to <10 ppm, DNA >3 LRV, Virus >4 LRV. A unique feature of ChromaSorb™'s chemistry is the ability to bind impurities at high conductivities (14mS) providing a greater reduction in buffer usage over traditional membranes and resins.

Successful innovation and knowledge transfer is pivotal to the fast-moving biopharmaceutical sector. bioProcessUK is the Knowledge Transfer Network that supports the development of the biopharmaceutical bioprocessing Industry. bioProcessUK was established in 2005 to facilitate the delivery of the 2003 Bioscience Innovation Growth Team’s (Bioscience 2015 www.bioindustry.org/bigtreport) recommendation to build an internationally competitive biopharmaceutical bioprocessing sector in the UK and undertake to: Build a network of bioprocessing Centres of Excellence across the UK, attract significant inward investment in bioprocessing assets andfoster bioprocessing community development. The talk will discuss the success of a number of activities formulated to deliver these objectvies such as: Supporting the development of the academic bioprocessing sector in the UK, improving academic-industry interaction, securing funds from government and research councils for biopharmaceutical bioprocessing and cell therapies R&D programmes

The use of high throughput (HT) technologies in process development has held an allure for many years. Whilst these technologies can significantly decrease timelines and increase probabilities of success, they are not without cost and limitations. Success depends on understanding realities such as (1) time upfront to test the capabilities and limitations of the instruments, (2) the addition of any technology will affect upstream and downstream workflows and (3) a data management plan and tools are required. This workshop will explore examples of HT technologies integrated in relevant workflows.

Ing-Marie Olsson graduated as PhD from Umeå University 2006 where she studied Chemometrics with an emphasis on Design Of Experiments (DOE). Since then Dr. Olsson is working as application specialist at Umetrics AB where the main focus is application of DOE and Multivariate Data Analysis (MVA) within pharma R&D. In Umetrics PAT-team Dr. Olsson has been leading the development of project models for efficient use of DOE and MVA in QbD and PAT focusing on applications within Biotech manufacturing.Umetrics as experts in multivariate technology including Design of Experiments are encouraged by the ICH8 Q8 Annex (EMEA/CHMP/ICH/518819/2007) which states “it is possible to define a design space as a time dependent function (e.g., temperature and pressure cycle of a lyophilisation cycle), or as a combination of variables such as principal components of a multivariate model”. Umetrics will share its experience based on a number of performed projects of what’s needed to meet these criteria. The visualization and increased interpretation can be used both for monitoring as well as for increased process knowledge and continuous improvement.

Russell Wong is currently a Senior Process Engineer with Bayer Healthcare in Berkeley, California. He is the site technical expert for single use disposable bioprocessing systems. The Bayer facility in Berkeley is recognized for it’s pioneering use of plastic disposables for fermentation, purification/isolation, and downstream processing. Dr. Wong joined Monsanto Plastics (later Bayer Plastics) in Springfield, Massachusetts in 1991 where he developed ABS plastics for specialty industrial applications as well as medical molding products. He holds a BE in Chemical Engineering from the Cooper Union and an MS from the University of Utah in Bioengineering where he began his interests in the medical application of polymers. He completed his PhD at the University of Tennessee in Polymer Engineering with research into biomedical polyurethanes used for cardiovascular applications.

Professor Rolf G Werner is Managing Director of the Corporate Division for Biopharma­ceuticals at Boehringer Ingelheim GmbH and responsible for the strategic orientation and the worldwide business of biopharmaceuticals. He joined Boehringer Ingelheim in 1973, after obtaining his PhD at the University of Tübingen. In 1990 he was appointed as professor at the Faculty of Biology at the same university. Throughout his time at Boehringer Ingelheim, he has worked in positions of increasing responsibility in the biopharmaceutical division before being promoted to Managing Director in 2000. In January 2004, he received an honorary doctor degree from the University of Chiang Mai in Thailand.

Dr. Windisch is in charge of the technical development and clinical manufacturing of therapeutic proteins and glycoproteins at Novartis globally. At Novartis, a single development and manufacturing organization, Global Biopharmaceutical Operations, encompassing seven sites in Europe and the US employing about 1700 associates serves needs of both, Novartis Pharma (innovative biopharmaceuticals) and Sandoz (biosimilars). In addition, this organization supports Novartis Vaccines and develops and manufactures multiple products in collaboration with other large biotech and pharma companies. Dr. Windisch’s expertise is in process development, analytics, manufacturing, GMP, and regulatory affairs for therapeutic proteins. In his more than 10 years at Novartis/Sandoz, Dr. Windisch has worked on more than 20 different biopharmaceuticals, ranging from peptides to antibodies. This work has resulted in marketed products and numerous patent applications. In the recent years, Dr. Windisch has worked extensively on comparability and quality by design concepts. Prior to joining Novartis/Sandoz he spent several years in academia working on structure-function relationships in glycoproteins. Dr. Windisch was educated in Europe and in the US and holds a PhD in biochemistry.

Dr. Joe X Zhou is Principal Scientist in the Process Development Department, Amgen Inc. Dr. Zhou’s expertise is in non-cGMP and cGMP protein/antibody therapeutics purification/production. He is experienced in all aspects of process research, process optimisation, viral clearance, and characterization as well as laboratory set up and project management. He has completed seven patent applications, five process publications and three book chapters since joining Amgen in 2004, received many awards and spoken at many international conferences. He has over 45 full research articles and 12 abstracts published in peer-reviewed journals. Dr. Zhou is also the co-author of six registered US patents. He received his Ph.D. degree in Biopharmaceutical Sciences from Queen’s University of Belfast, M.S. in Enzymology/Biochemistry and B.S. in Microbiology from Liaoning University. He was appointed Lecturer in Biochemistry and Research Director on the Scorpion venom project in Shenyang Pharmaceutical University, China. He has been a member of the American Association of Pharmaceutical Scientists for over 10 years and is currently a member of the American Chemistry Society.

Kim Sandell joined Pfizer in Strängnäs, Sweden 1999. He holds a master degree in chemical engineering from Royal Institute of Technology Stockholm, Sweden. Kim is currently holding a position as project director for a new biotech plant under construction in Strängnäs. He is responsible for the end user representation and start-up activities for this new facility. Kim has held a range of position at the site starting as a process engineer moving into project lead and quality support to projects. He then resumed responsibility for the manufacturing at the site until he joined the project team for the new facility. Strängnäs is a site focused in biotechnological API production with bacteria as expression systems. Staring up the new facility will also mean that two new processes for the API for Genotropin® and Somavert® will be transferred to the site this is also within Kim’s responsibility.

Dr. Michael Brown is Head of UK Operations for Lonza Biologics, responsible for process scale-up plus small scale clinical and commercial GMP manufacturing of recombinant proteins and therapeutic monoclonal antibodies based in Slough UK. Previous roles within Lonza have been based in Research and Development specialising in fermentation optimisation of mammalian cell cultures, primary separation technologies, process transfer into manufacturing and scale-up of processes from 200 to 20,000 L. Once a microbial physiologist, Mike had several roles in R&D at Celltech Biologics and has a Ph.D. in Microbiology from the University of Surrey, UK.

Alain Lamproye currently holds the position of Associate Director in the Biotech Process Development department of Serono (Vevey, Switzerland). He is responsible for the management of all activities related to the development of production processes for recombinant proteins, from cell culture to purification and pre-formulation of bulk drug substance, as well as analytical activities. Prior to this position, he was head of the Downstream Development group, within the Biotech Process Development department. His main responsibilities included purification process development, process scale-up, viral clearance validation, process characterization and validation. Before joining Serono in 2003, he had accumulated over 14 years of experience in the field of bioprocess development and GMP production of recombinant proteins. This experience was acquired at Eurogentec - a CMO based in Belgium - where he held several positions ranging from Scientist to Project Leader and Head of GMP operations. Alain Lamproye is graduated from the University of Liege (Belgium) with a M.Sc. in Biology.

Dr. Richard Francis has over twenty years experience in development and manufacture of biopharmaceutical products. With direct experience and responsibility for world-wide efforts involved in the approval process of eight biologic products (4 Mab, two polyclonal antibodies and two recombinant proteins). Experienced in Antibody, protein, DNA and viral gene therapy product types and well versed in worldwide product regulations, process development and manufacturing. Richard joined Protherics in 2001 and is Director of Process Development and Technical Support. He formed part of the teams that achieved licensure for several biological products in several companies with most world wide regulatory agencies. He designed and qualified many processes for the production of biopharma products. He is responsible for the manufacture of many biologics products with direct interaction with regulators. Richard chairs the innovative manufacturing research program at UCL. Prior to Protherics, Richard held positions at GSK, Centocor and Celltech Biologics.

Dr. Alahari Arunakumari is currently working at Medarex, NJ as the Director of Process Development Department, focusing on the development and transfer of cell culture and purification processes to internal manufacturing as well as outside CMOs. She has earned her Ph.D in Microbiology from University of Madras, India and held different corporate positions at Biotech and Pharmaceutical companies in US for the past 15 years. She has extensive and collective experience in microbial fermentation, mammalian cell culture and purification of biologics at Enzon Inc., BMS and Medarex. Her recent publications include “Scale -up Considerations for Biotechnology-Derived Products” in Pharmaceutical Process Scale-Up, 2006.

Dr. Lihua Huang is research advisor and group leader of protein structural characterization in bioproduct pharmaceutical development, Lilly research laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA. Dr. Huang joined Lilly in 1996. Since joining Lilly, he has been involved in protein and carbohydrate structural characterization support for approximately one hundred peptide, protein, glycoprotein and antibody drug lead/candidate optimization, development or launch from Discovery to Manufacturing. His group is currently focusing on structural characterization approaches to assess in vivo and in vitro properties of the leads/candidates, H/D exchange and protein surface labeling MS methodologies to specify protein/protein interaction sites, top-down and bottom-up approaches to elucidate post-translational modifications and sites of chemical/proteolytic instability as well as de novo sequence for antibody.

Dr. Berthold Bödeker joined the pharmaceutical division of Bayer AG in Wuppertal in 1983, where he held several positions in research and development for the production of proteins from mammalian cell culture. In 1988 he joined Miles Inc. (now Bayer Corp) in Berkeley, USA, where he was responsible for the technical development and manufacturing of recombinant factor VIII, Kogenate® , the first world-wide licensed recombinant protein from continuous perfusion culture, and later for all mammalian cell culture projects. Since 1993 he is back at Bayer AG in Germany, heading pilot plants and cell biology development and production at Pharma Biotechnology in Wuppertal. Since about 2 years he is also responsible for the new business area contract development and production of pharmaceutical biotech proteins for external clients.

With a degree in Chemical Engineering and a PhD in Biological Chemistry, I started to work in BS molecular biology laboratory in 1992. Then, I was responsible for the Production Area of Bacterial Fermentation and as from 1995, I became R&D manager. Several molecules produced in E.coli and mammalian cells (G-CSF, human growth hormone, etc.) were developed and launched in the market. Subsequently, I directed developments in gene therapies of revascularization and heart regeneration- now entering phase I clinical trial- and the successful obtaining of cloned and transgenic cows for the production of human recombinant proteins in their milk.

Aline Seilly has been with Millipore for the past 18 years where she had the opportunity to work closely with the biopharmaceutical producers on their applications development and process optimization. Today, with a team of Process development Scientists, Application Development Engineers, Validation and Training Specialists, she manages knowledge, resources and capabilities to deliver state of the art process solutions in a diversity of technologies such as Chromatography media, tangential flow filtration, Mobius disposable solutions, clarification and aseptic processing, virus clearance, integrity testing solutions and system hardware. She holds an expertise in process integration and compression at every stages of the drug development in applications such as Mabs, Vaccines and Recombinant proteins.

Dr. Sylvio Bengio received his Doctorate in ‘Cellular & Molecular Biology’ at the University of Rouen, France and conducted research in Cellular Immunology at the ‘National Institute of Health & Medicine’ (INSERM), on ‘Fc Receptors & Regulation of the Complement Response’. Since joining industry, Dr Bengio has cumulated over 20 years experience in Downstream Processing and Protein Purification. Working for Pall Life Science’s Chromatography Research and Biosepra Production Centre of Cergy (Paris, France), he specialises in Chromatography Process Development, Application of Novel Technologies and Scientific Communications.

Eric Grund has worked in the field of biomolecule separation for about 30 years, most of that time spent in what is now the Life Sciences division of GE Healthcare. He presently leads the Fast Trak team providing education, documentation, process development and consulting services to the biopharmaceutical industry. During this career he has auhored handbooks on several chromatography techniques, monoclonal antibody purification and protein purification, and has been involved in the development of well-known products for affinity chromatography, gel filtration, ion exchange chromatography and hydrophobic interaction chromatography. Over the last ten years his focus has been on industrial large-scale applications.

Dr. Sabine Geisse is an internationally recognized expert in eukaryotic cell biology with 19 years experience gathered from her PhDs in Nutrition and Human Biology at the Justus-Liebig-University in Giessen and Philipps-University in Marburg and as a postdoc at the University of Essen in Germany. She joined Sandoz/Novartis in 1988 within Discovery Technologies and is a scientific expert for Biomolecules Production. In 2004, she received the Novartis Leading Scientist award. Sabine Geisse built up and implemented an expression platform for transient expression technologies in eukaryotic cell lines and developed, among others, a HEK.EBNA expression system for transient and stable expression on small and large scale. She is constantly on the pursuit of new expression systems and useful cell lines and her evaluation and advancement of techniques provides essential support to Novartis Research for the rapid generation of recombinant proteins as tools and/or early drug development candidates.

Roland Mainil graduated in Chemical Engineering from the Faculté Polytechnique de Mons, in Belgium. He joined GSK Biologicals in 1994, the world center for human vaccine of GSK. He worked in the scaling-up department, for several projects including the first human vaccine against Lyme disease ( Lymerix® ), the scaling-up of the fermentation and purification of several bacterial polysaccharide , the formulation of combined vaccine ( Infanrix® ), the development of several polysaccharide-protein conjugates, the downstream processing of influenza viruses. He is also involved in the start-up of new scaling-up units and in the design of new manufacturing process.

Prof. Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in Chemical Reaction Engineering, with particular emphasis on polymer reactions and reaction-separation processes based on continuous chromatography. More recently, his interest in chromatographic separations is evolved in the area of biomolecules with specific focus on therapeutic proteins and monoclonal antibodies. The general aim of his research is the development of new concepts for the down stream processing of these materials. Massimo Morbidelli is co-author of more than 300 papers, 11 international patents and four books. He serves as a member of the Editorial Board of the Cambridge University Press Series in Chemical Engineering, as well as of several international scientific journals. He is a member of the Scientific Advisory Board of the Max-Planck Institute for Dynamics and Complex Technical Systems, Magdeburg, Germany. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers.

Dr. Boussif is the head of proteins formulation unit at Sanofi-Aventis R&D for the development of biotech products. He has over 12 years experience in bioprocess development and formulation of both recombinant proteins and gene therapy products. He is author and co-author of several publications in peer-reviewed journals. Dr. Boussif obtained his Ph.D in Biophysico-chemistry sciences and his M.S. in Biochemistry and Organic chemistry at Strasbourg University, where he developed the widely used PEI-mediated gene transfer system known as JetPEI®. After his Ph.D he joined Transgene in Strasbourg where he developed several lipid and polymer based non-viral vectors (carriers) of DNA, peptides, and proteins for gene and drug delivery applications. In 2000 he joined Aventis-Gencell where he worked as Head of Preclinical manufacturing and formulation. He recently moved from Laboratoires SERONO S.A., where he was in charge of preformulation activities within Downstream Processing, to Sanofi-Aventis R&D where he is leading Biotherapeutics formulation unit within Pharmaceutical Sciences Department.

Bruce Williams is the Commercial Engineering Manager at Avecia, Tees Valley, UK. Since joining the company in 1998 he has developed its systems and capabilities in scale-up and engineering of robust manufacturing processes for recombinant protein products. Bruce represents Avecia on a consortium project, partly funded by the UK Department of Trade and Industry, which is developing software tools to support the bioprocessing industry. The consortium is led by Andrew Sinclair of Biopharm Services Ltd, with Cambridge Antibody Technology as the third partner. He is a chartered engineer with an MEng in Chemical and Process Engineering from the University of Newcastle upon Tyne, specialising in Biotechnology and Process Control.

Dr Stückrath began his career with Aventis in 2000 as a Trainee in an assistant plant manager programme. Until 2002 he was responsible for a fermentation plant in the insulin field of Aventis. After becoming a Six Sigma Black Belt Dr Stückrath was made responsible for the implementation of Six Sigma at a site of 800 employees. After becoming Six Sigma Master Black Belt he became part of the Management Committee of the Site Frankfurt Biotechnology in 2004, being responsible for all Industrial Excellence activities of the site. In 2005 his work was recognized with the Six Sigma IQ Excellence Award in the category “Best Defect Elimination in Manufacturing." Dr Stückrath studied Biology with a major in Microbiology in Frankfurt/Germany and Anchorage, Alaska USA. He holds a Ph. D. in biology.

Dr. Gottschalk joined Sartorius in 2004 as Vice President of Purification Technologies with a global responsibility for bioseparation products. Prior to that, he was working for Bayer Health Care in different positions and became head of the GMP protein purification facility in Wuppertal (Germany). He was responsible for the production of monoclonal antibodies and recombinant proteins from various expression systems. Dr. Gottschalk holds a Ph.D in Chemistry from the University of Münster. He has various publications in the area of Biotechnology and somatic Gene Therapy and is Head Lecturer at the University of Witten (Germany).

Dr Rhodes joined bioProcessUK as Technical Director in June 2005 from Serologicals Corp. where he had worked since 1996 in a number of roles in both the UK and US, most recently as Director, Scientific Operations, Global R&D. He played a pivotal role in the success of Bioscot (now Celliance Ltd.), which has been part of the Serologicals Corporation since 1989. He has also worked as Director of R&D at Archaeus Technology Group and was Head of Process R&D at Celltech (now Lonza Biologics) and in bioprocess development at Pfizer. He has a PhD in Biochemical Genetics from University College, London. He is interested in Life Sciences innovation, especially in effecting technology transfer of the latest discoveries from academia into industry. At bioProcessUK he is responsible for leading and implementing the development of the bioprocessing technical strategy in the UK.

Sharon worked within clinical trials at Guys Hospital in London prior to taking up a research position at Celltech. Sharon subsequently moved to Celltech's manufacturing business, and held various management positions within contract manufacturing. Following this, Sharon moved to Project Management, and managed preclinical and clinical development programmes at Celltech for both new chemical entities and new biological entities. Following the mergers of Celltech with Chiroscience and Medeva, Sharon became Head of Biologics Manufacturing Development, and was responsible for the delivery of biological products from the preclinical stage to market launch. From 2002 - 2004, Sharon was Director of Westerly Projects Ltd, a consultancy company offering development services to the biopharmaceutical industry globally. Sharon joined Antisoma in 2004 as Director of Project Management and Manufacturing, and has responsibility for CMC activities and project and portfolio management. In addition, Sharon has chaired the Manufacturing Advisory Committee for the BIA since 2003