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07:45 Registration and Morning Coffee
08:30 Chairperson’s Remarks
Mike Molloy, Ph.D., Head, Analytical and Product Characterisation, GlaxoSmithKline
08:40 Fingerprinting Antibody Epitopes: Identifying Even Minor Variations for QC and IP
Michael Szardenings, Dr.rer.nat., Group Leader, Immunology, Ligand Development, Fraunhofer Institute for Cell Therapy and Immunology
Precise and comparative description of antibody binding sites is important for many reasons. Next generation sequencing in combination with a novel peptide phage display setup allows almost automated in silico analysis of a plethora of binding peptide variants. This routine procedure reveals not only the epitope, it renders in depth details of mimotope variations. These variations are individual signatures not only of different antibodies but also of batch to batch differences.
09:10 New Capillary Electrophoretic Systems for the Affinity Assessment of Protein Mixture Components
Gerhardus de Jong, Ph.D., Professor, Pharmaceutical Sciences, Utrecht University
We have developed capillary electrophoresis (CE) systems for the study of the affinity of proteins and protein variants to receptors and enzymes. In the first approach, different concentrations of the target protein or ligand are added to the background electrolyte and the affinity of the proteins is assessed by the change of electrophoretic mobility. In the second approach, affinity-specific detection is obtained by the on-line combination of CE and surface plasmon resonance.
09:40 Problem-Solving Breakout Discussions*
Epitope Mapping Approaches
moderator: Michael Szardenings, Dr.rer.nat, Group Leader, Immunology, Ligand Development, Fraunhofer institute for Cell Therapy and Immunology
Analytical Strategies for Developability Assessments
moderator: Mike Molloy, Ph.D., Head, Analytical and Product Characterization, GlaxoSmithKline
- What are the key analytics that can really differentiate a lead panel (Biophysical vs Physchem analytics)?
- How important is concentration, do we overlook developability issues by doing analytics at lower concentrations?
- How important is the material source (HEK vs CHO) and quality of lead panel material?
- What are the advantages and disadvantages of employing generic methods?
10:40 Coffee Break in Exhibit Hall with Poster Viewing
11:20 Novel Approaches for Rapid Degradation Hotspot Profiling of Biotherapeutic Candidates
Bjoern Hueber, Senior Analytical Expert, Novartis Pharma AG
Degradation reactions such as asparagine deamidation and aspartate isomerization can present major risks for the developability of innovative biotherapeutics. Although in silico sequence analysis can help to predict potential degradation sites, time- and labor- intense characterization is still required to identify critical degradation hotspots in biologics lead candidates. This talk presents case studies using novel screening assays combined with a new UPLC-IM-MS platform for rapid and higher throughput monitoring of deamidation or isomerization hotspots.
11:50 Developability Assessment of Complex Biologics
Laurent Lariviere, Ph.D., Principal Scientist, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Penzberg, Roche Diagnostics GmbH
Complex biologics such as multispecific antibodies or fusion proteins play an increasingly important role as emerging new pharmaceuticals. In contrast to classic monoclonal antibodies, complex biologics can pose additional developability challenges. The talk will focus on our strategies to design and optimize stable, well-behaved drug candidates.
12:20 New Applications for Array-Based SPR Imaging
Alex van der Kooi, Manager, Interaction Laboratory, IBIS Technologies
12:50 Luncheon Presentation: Explore Prometheus: Biologics Stability Screening Has Never Been Faster, Easier & More Fun
Dennis Breitsprecher, Ph.D., Head, Research and Development – Biochemistry, NanoTemper Technologies, GmbH
Beate Kern, Ph.D., Application Specialist, NanoTemper Technologies, GmbH
Prometheus series instruments allow for rapid and precise high-throughput stability screenings, while providing best-in-class high resolution thermal unfolding data for biologics, independent of buffer or protein concentration. It allows for an exact detection of aggregation onset temperatures and aggregation behavior to find the conditions in which the protein is most stable.
Explore the Prometheus at the live demo and see how instrument and straightforward software solutions bring a whole new experience to your lab!
13:20 Session Break
14:00 Dessert Break in the Exhibit Hall with Poster Viewing
14:30 Chairperson’s Remarks
To be confirmed
14:35 Building a Pipeline in Immuno-Oncology: Bispecific Antibodies from Engineering to Optimized In House Phase One Manufacturing
Stanislas Blein, Ph.D., Head, Antibody Engineering, Glenmark Pharmaceuticals
Glenmark Pharmaceuticals’ BEAT® platform is a robust and versatile bispecific antibody platform based on a unique heavy chain hetero-dimerization technology. We have produced several T-cell recruiting bispecific antibodies against different cancers, with GBR 1302 being our most advanced development candidate. This BEAT® antibody potently re-directs T-cells to HER2 positive cancer cells with an excellent safety-efficacy margin. GBR 1302 was successfully manufactured and will shortly enter clinical phase. Bioprocess and preclinical data will be presented.
15:05 New Strategy for an Old Target: How to Make Extremely Potent Anti-ErbB2 Agents
Rastislav Tamaskovic, Ph.D., Researcher, Department of Biochemistry, University of Zurich
We have recently developed a novel approach employing biparatopic anti-ErbB2 Designed Ankyrin Repeat Proteins (DARPins). By creating an intermolecular trap with DARPin agents, which simultaneously target two distinct ectodomain epitopes of ErbB2, the receptors adopt an inactive conformation with kinase domains incapable of productive interactions. This strategy represents a rational approach to engineer anti-ErbB2 agents inducing cell-specific apoptosis based on a structurally and mechanistically understood principle, without using a toxic payload causing potential off-tumor side effects.
15:35 The Importance of Biophysical Screening in Predicting the Perils of UF/DF
Marisa Barnard, Ph.D., Senior Scientist, Biopharm Molecular Discovery, GlaxoSmithKline
16:05 Extending Drug Half-Life to Achieve Monthly Dosing? The Potential of Veltis® Engineered Albumins for Optimized Dosing
Joanna Hay, Ph.D., Science Manager, Customer Solution, Albumedix Ltd.
Short circulatory half-life represents a major obstacle for many protein and peptide-based therapeutics. This can be significantly improved by conjugation or fusion to albumin, due to increased size and recycling via the neonatal Fc receptor (FcRn). The increased FcRn affinity of the Veltis® engineered albumins translates to more than doubling of the already long half-life of native albumin. We will describe rationally engineered albumins and their application to improve the pharmacokinetic properties of therapeutic candidates.
16:35 Refreshment Break in the Exhibit Hall with Poster Viewing
17:15 New Solution for Label-Free Biomolecular Interaction Screening
Chiraz Frydman, Ph.D., Product Manager, Horiba Scientific
Label-free biomolecular interaction analysis is increasingly moving towards screening approaches. The XelPleX platform makes it easier and faster than the conventional techniques. Let’s show you how your assay will benefit not only from the advantage of the multiplex but also of the binding affinity determination.
17:30 Improve Productivity of Cell Line Development Using the ClonePix™ 2 and CloneSelect™ Imagers
Sarah Rowe, European Application Scientist, Molecular Devices
Molecular Devices offers automated solutions for screening and selection of mammalian clones or microbial colonies. The CloneSelect™ Imager replaces time-consuming, subjective manual inspections of mammalian cells with consistency and objectivity. Re-designed to provide high resolution and fluorescence imaging, all of our CSI models have proven scalable automated use.
17:45 Attribute Tailored Bioprocess Development to Allow ‘Designed In’ Appropriate Product Quality
Karolina Les, Ph.D., Scientist I, Purification Process Sciences, Biopharmaceutical Development, MedImmune
MedImmune’s pipeline has diversified from predominantly antibodies to include many novel molecules of increased complexity. Development of novel biologics can be challenging and often carry higher risks. These can be addressed by early developability assessments and identification of potential critical quality attributes (pCQA). Case studies highlighting challenges encountered during early development of novel molecules are presented, showcasing how quality can be built into the molecules and bioprocesses in a systematic, science-based manner.
18:15 Preclinical Tools in Formulation Optimization to Improve Biological Performance of Antibodies
Sabine Eichling, Ph.D. Student, NBE Formulation Sciences, Abbvie Deutschland GmbH & Co. KG, University of Heidelberg
Formulation development for biologics has primarily focused on the refinement of physical and chemical stability during shelf-life. Effects of formulation composition following subcutaneous injection and reduced bioavailability were usually not considered. The addition of biological read out parameters enables further improvement in the antibody transport to the target tissue. We develop translatable models to understand the transport of antibodies following subcutaneous injection and predict the effect of the formulation on the bioavailability.
18:45 End of Optimisation & Developability
Day 1 | Day 2 | Speaker Biographies | Download Brochure