Registration

Bench to Bedside with Pichia: Recombinant Antibody-Based Cancer Treatments
Kerry Chester, Professor, University College London, United Kingdom

Successful application of the Pichia pastoris expression system for production of recombinant clinical grade antibody-based therapeutics.

Recruiting T Cells for Cancer Therapy by BiTE Antibodies in Clinical Trials
Ralf Lutterbuese, Director BiTE Research, Micromet, United Kingdom

BiTE antibodies are single-chain bispecific antibodies directing cytotoxic T cells to target-expressing cancer cells, leading to highly efficient lysis of target cells. CD19-specific Blinatumomab has shown very high response rates in NHL and ALL patients in phase 1 and 2.

Coffee Break and Networking in the Exhibition Hall

Antibodies and Antibody RNase Fusion Proteins Targeting CD30+ Lymphoma
Thomas Schirrmann, Research Group Leader, Technische Universitaet Braunschweig, Germany

CD30 specific recombinant human antibodies and immunoRNases are produced in high levels using mammalian cell lines. Antibodies as well as immunoRNases mediate inhibitory effects on Hodgkin lymphoma cell lines but immunoRNases show higher efficacy.

A Tetravalent Bispecific Antibody (TandAb) for Treating Hodgkin´s Lymphoma – from Gene to Clinic
Melvyn Little, Chief Scientific Officer, Affimed Therapeutics AG, Germany

Immune effector cells are powerful killing agents. To harness them for treating tumors such as Hodgkin´s Lymphoma, we have developed a highly effective bispecific antibody format (TandAb). Product development from the gene to the clinic will be described.

Lunch and Networking in Exhibition Hall

Poster Viewing Session

Bicyclic Peptides with Antibody-Like Binding Affinity and Specificity
Christian Heinis, Assistant Professor, Ecole Polytechnique Federale de Lausanne, Switzerland

We had generated large combinatorial libraries of phage-encoded bicyclic peptides and isolated from them ligands to various disease targets. The bicyclic peptides combine key qualities of antibody therapeutics (high affinity and specificity) and advantages of small molecule drugs.

Targeting Protein-Protein Interactions with Interfering Peptides
Katja Arndt, Professor, University of Potsdam, Germany

Protein-protein interaction surfaces are attractive yet challenging targets for disease intervention. Combine rational design with in-vivo and in-vitro selection, we generate peptides specifically targeting intracellular protein interaction domains. Inhibitor activity can be controlled via photo-switchable linkers, and D-peptides show enhanced proteolytic stability.

Coffee Break and Networking in the Exhibition Hall

Molecular Characterization of Biopharmaceutical Processes Using Luminescent Technologies: Applications in Biologics Discovery, Bioreactor Monitoring, and QA/QC Testing
John Watson, Director, Promega Corporation, United States of America

Glycosylation of IgG Antibodies: a Critical Quality Attribute (CQA)
Roy Jefferis, Professor Emeritus, University Of Birmingham, United Kingdom

The biologic activities of natural IgG antibodies are determined by the glycoform profile; orchestrated by the immune system. Production cell lines deliver a fixed glycoform profile; therefore, resort is made to cell and protein engineering.

Folding and Aggregation of IgGs - Influence of Mutations and Expression Systems
Jonas Schaefer, Researcher, University of Zurich, Switzerland

Framework mutations have previously shown to greatly influence folding and stability of scFv expressed in bacteria. While analyzing the effects of different eukaryotic expression systems as well as various antibody formats, similarities and differences in antibody biosynthesis and characteristics were encountered and will be presented.

Drinks Reception

Biosimilars, What’s in the Name?
Paul Declerck, Professor, Katholieke Universiteit Leuven, Belgium

Being copies of complex biological molecules, biosimilars can be considered similar but not identical to their reference product. The scientific approach to their safe introduction differs significantly from that for generics. Implications for patients and healthcare professionals will be discussed and illustrated by specific examples.

Biosimilars, What’s in the Name?
Paul Declerck, Professor, Katholieke Universiteit Leuven, Belgium

Being copies of complex biological molecules, biosimilars can be considered similar but not identical to their reference product. The scientific approach to their safe introduction differs significantly from that for generics. Implications for patients and healthcare professionals will be discussed and illustrated by specific examples.

Biosimilars - Will They be Worth the Effort?
Peter Wittner, Senior Consultant, Interpharm Consultancy, United Kingdom

Biosimilars have attracted interest as a way of reducing the high costs of treatment with biological products. The costs of market entry in regulated Western markets are high and market penetration has been poor so far; can companies gain the rewards they hoped for?

Biosimilars, Bio-betters, Comparability and Adverse Reactions
Roy Jefferis, Professor Emeritus, University Of Birmingham, United Kingdom

The first essential for a biosimilar is that the sequence is identical to that of the innovator protein. However, bulk recombinant proteins are structurally heterogeneous and control over post-translational modifications presents a formidable challenge.

Coffee Break and Networking in the Exhibition Hall

Background and Key Drivers Leading to Clinical Immunogenicity
Matthew Baker, Chief Scientific Officer, Abzena, United Kingdom

• Data showing in silico and in vitro T cell epitope identification technologies employed at various stages of the development pipeline to help optimise pre-clinical decision making • Specific examples where these technologies have been used for the detection of immunogenicity • Solutions for the rational design and engineering of protein therapeutics to reduce the risk of immunogenicity

Lunch and Networking in Exhibition Hall

Poster Viewing Session

Biosimilars and the US-legislation: Analytical and Clinical Challenges
William Egan, Executive Director, PharmaNet Consulting, United States of America

Recent legislation in the US provides a path forward for the licensure of biosimilar proteins; this legislation also allows for the interchangeability of the biosimilar with its reference product. This talk will emphasize some of the analytical and clinical challenges in demonstrating the “highly similar” nature of the biosimilar candidate and reference product, particularly for more complex proteins, such as the monoclonal antibodies.

EU Regulatory Landscape for Approval of Biosimilars
Lincoln Tsang, Partner, Arnold & Porter LLP, United Kingdom

This presentation will address the regulatory framework and standards for approval biosimilar products by reference to established guidance documents and examples to illustrate the EU regulators’ attitude towards the dossier requirements. A comparative analysis will be made against the international standards for approval of biosimilars.

Coffee Break and Networking in the Exhibition Hall

Improving on Rituximab – Selecting CD20 mAb for the Future
Mark Cragg, Professor, University of Southampton, United Kingdom

The anti-CD20 mAb Rituximab, has transformed treatment of lymphoma. Despite this success a substantial proportion of B-cell lymphomas are refractory. Here, we present the case for focusing on so-called type II anti-CD20 mAb in the future.

Moving from Biosimilars to Biobetters with PEGylation
Stephen Brocchini, Professor, University of London, United Kingdom

The biosimilars markets for endogenous cytokines such as interferon alpha-2 and GCSF were eroded by the introduction of their PEGylated variants. PEGylation allows for decreased dosing frequency which can be important for improved patient compliance and efficacy. Continued improvements in PEGylation technologies to achieve better product homogeneity provide opportunities to develop biobetter versions of both PEGylated and non-PEGylated protein based medicines.

Close of Conference