Tuesday, 21 October
15:30 - 16:30 Early Registration, Poster and Exhibit Setup
Wednesday, 22 October
8:00 Registration & Morning Coffee/Poster & Exhibit Set-Up
9:00 Welcome by Session Chairperson
9:15 Hucal®-based Antibodies – Innovative Therapeutics And Essential Research Tools
Marlies Sproll, Ph.D., Chief Scientific Officer, MorphoSys AG, Martinsried/Germany
Antibody-based medicines have contributed significantly to improved therapeutic outcomes for severe and life-threatening diseases. In addition, antibodies are critical tools for scientific research and modern diagnostic medicine. MorphoSys has leveraged its proprietary technologies and its broad antibody expertise to establish a leading position in its core markets – the discovery of antibody therapeutics, and antibody-based research products. Recent progress will be described.
ANTIBODY DISCOVERY AND DEVELOPMENT
9:45 Secretion of Antibody Fragments and Target-Binding Proteins with E. coli
Thomas Maier, Ph.D., Managing Director, Wacker Biotech GmbH
Secretion from E. coli into the culture broth is a unique feature and cuts down on manufacturing costs in down-stream purification. Wacker has developed a technology for efficient high level secretion of recombinant proteins from E. coli K12. This secretion technology is successfully used for technical applications on a 4000 L scale with yields of up to 7 g/l protein product in the culture broth. This technology can also be applied for biologics manufacturing and a yield of 5 g/l of a therapeutic protein has already been achieved. The system is a platform technology for production of antibody fragments achieving yields of > 2 g/L. The presentation will focus on case studies that showed that the expression system is highly efficient for the production of antibody fragments and other binding proteins. It even proved to be an enabling technology in the case of a lipocalin protein.
10:15 Single-Batch Production of Recombinant Human Polyclonal Antibody
Alexandra Baer, Ph.D., Senior Scientist, Symphogen A/S
Symphogen has developed an expression platform, Sympress, for consistent production of target-specific recombinant human polyclonal antibodies. Simultaneously, a characterization strategy for analysis of the polyclonal products has been designed and developed, to gain regulatory acceptance of this new drug class. The first drug product manufactured by use of Sympress has now entered the clinic.
10:45 Morning Coffee, Poster and Exhibit Viewing
11:15 Designing Antibodies to Enable Quality from the Start
Taruna Arora, Ph.D., Principal Scientist, Amgen Inc.
Antibody engineering can be a powerful tool for designing quality in the product. Implementing design from the start helps lessen process related intricacies, stability to formulation conditions, and at the same time, ensures speed to clinic. Discussed here are applications of antibody design and selection for lead candidates to achieve goal of best activity combined with favorable manufacturability and quality profile.
ENGINEERING ANTIBODY IMPROVEMENTS
11:45 An Fc-Engineered Anti-CD19 Monoclonal Antibody with Potent in vitro and in vivo Activity against Lymphoma and Leukemia
Eugene Zhukovsky, Ph.D., Associate Director, Research, Xencor, Inc.
The broad clinical application of the anti-CD20 antibody rituximab has demonstrated the benefit of B cell depletion for the treatment of B cell neoplasms; however, the relapse rate and the growing number of patients resistant to this treatment indicate the urgent need for new non-cross-resistant therapies. CD19 is an excellent target for antibody-based therapies due to the pan-B cell expression profile of this antigen. In order to develop a highly cytotoxic anti-CD19 antibody (XmAb5574) we employed protein engineering and increased the affinity of the Fc domain for Fc(gamma)Rs on immune effector cells. XmAb5574 displayed dramatically increased cytotoxic activity relative to the native unmodified analog ex vivo (patient-derived tumor cells), in vivo (lymphoma mouse xenografts), and in a broad array of in vitro assays (ADCC, phagocytosis, apoptosis). This indicates that XmAb5574 is a promising experimental therapeutic and warrants further clinical evaluation.
12:15 Luncheon Technology Workshop Sponsored by 
SlonoMax™ - A New Quality Level in Tailoring Genetic Diversity
Jan Van den Brulle, PhD, Scientific Director, Sloning BioTechnology GmbH
Based on its patented Slonomics™ technology platform Sloning has developed SlonoMax™, a unique family of synthetic mutant libraries for strategic protein engineering. By using double-stranded DNA triplets for the synthesis process, the number and ratio of mutations can be fully controlled at any desired sequence position.
13:45 Comments by Session Chairperson
13:50 Domain Antibodies and Engineered Human Antibody Constant Domains (Nanoantibodies) Against HIV and Cancer
Dimiter Dimitrov, Ph.D., Senior Investigator, Center for Cancer Research Nanobiology Program, NCI-NIH
We have identified and characterized a highly soluble and stable human VH domain antibody that was used as a scaffold for construction of two large (size 2x1010) libraries of high diversity. Several high affinity domain antibodies against HIV and cancer-related proteins were identified and characterized with potential use as therapeutics. We have also engineered human antibody constant domains as scaffolds that are highly soluble, stable and express at high levels. Based on these new scaffolds, several libraries have been constructed and binders against various antigens are being selected. These new types of antibodies not only can bind specifically to an antigen but could also mediate effector functions characteristic for full size antibodies, i.e. they could function as “nanoantibodies” with sizes about 10-fold lower than the size of an IgG.
14:20 Preclinical Development of Antibody Combinations and Bispecific Antibodies for Anticancer Therapy
Zhenping Zhu, ImClone Systems Incorporated
Combinations of antitumor antibodies may provide greater efficacy than single antibody without adding significant toxicities. However, the research and development costs of antibodies pose a significant barrier to the use of antibody combinations. An emerging alternative is the use of dual-targeting bispecific antibodies (BsAb) that target simultaneously two tumor-associated antigens, thus providing a means of delivering two therapeutic moieties in one molecule. The rationales and biology of developing antibody combination and BsAb therapies will be discussed.
OVERCOMING CHALLENGES
14:50 Designing Manufacturability into Antibody Therapeutics
Jesus Zurdo, Ph.D., Head of Research & Development, Advanced Protein Technologies, Lonza Biologics plc
Protein stability and aggregation are major, and still largely unsolved, issues affecting the development, production and safety of biopharmaceuticals. The AggreSolve™ in silico platform includes a collection of predictive tools that have been developed to overcome protein stability and aggregation issues, providing solutions to improve the quality of polypeptide drugs. These tools have been effectively used in re-designing antibody molecules with enhanced stability in solution, whilst retaining their physiological activity.
15:20 An Engineered IgG1 Mediating Improved ADCC
Carl Webster, PhD, Head of Research Technology, MedImmune Ltd.
Ribosome display has been applied to human IgG1-Fc in order to select for variants having improved binding to human FcgRIIIa, the receptor expressed on human killer cells that mediates antibody dependent cellular cytotoxicity (ADCC). One particular variant selected showed a significant increase in the ability to trigger ADCC relative to wild-type antibody, and gave more equal levels of ADCC than wild-type IgG for each allotype of FcgRIIIa, V158 and F158. As well as improvements due to amino acid substitutions, analysis of the carbohydrate attached to asn297 revealed significant changes in the profile compared to wild-type, including reduction in the levels of fucosylation.
15:50 Sponsored Technology Solution #1 
Balancing Power and Simplicity in Real-Time, Label-Free Characterization/Selection of Antibodies – What’s the Added Value of Biosensors?
Alexander Kovacs, PhD, Global Product Manager, Attana AB
This presentation will discuss the applications of Attana's label-free and real-time analysis technology to address the current market needs for high quality and cost-efficient analysis of molecular interactions.
16:05 Sponsored Technology Solution #2
(Sponsorship Available)
16:25 Afternoon Refreshment Break, Poster and Exhibit Viewing
16:55 Problem Solving Roundtables
Break-out Sessions are one hour group discussions focused on a particular topic. This is a moderated discussion with brainstorming and interactive problem solving amongst scientists from diverse areas who share a common interest in the discussion topic.
18:00 Networking Reception in the Exhibit Hall