Posters

Title and Abstract Download Application
Impact of Outsourcing on Result Quality in Screening: How to Keep Data Analysis Workflows Under Control

Presented at the SLAS2017

Outsourcing of screening can pose massive challenges to pharmaceutical research organizations. Experimental procedures, research processes and results that have painstakingly been standardized and perfected over years are now placed in the hands of contract research organizations (CROs) or other collaboration partners. This creates uncertainty regarding source, quality, and significance of results. It can lead to mismatches with internal experimental procedures and research processes when only parts of the screening are out-sourced. This makes it difficult to deeply...

Request HTS, Ion Channel Screening, Hit & Lead Identification, HCS, Compound Combinations, Biophysics, Surface Plasmon Resonance, Thermal Shift Assays
A New Analysis Pipeline to Improve Assessment of Cardiac Liability in High Throughput Electrophysiology Screens with Routine MoA Detection for Slow Onset Compounds

Presented at the SLAS2017

Automated patch clamp screens generate highly valuable information for drug research programs. In particular, in safety pharmacology early testing is nowadays seen as a cornerstone for managing risk of later failure and patients’ health. Thus, more predictive and affordable screens need to be introduced to gain both specificity and throughput e.g. for cardiovascular liability detection and resolution. At AstraZeneca, we have implemented the Nanion Syncropatch 384PE electrophysiology platform, delivering higher throughput measurements for hERG and other key cardiac...

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Fast and Accurate Assessment of Binding Kinetics in HTS Format with the Kinetic Probe Competition Assay and Genedata Screener

Presented at the SLAS2017

Since the introduction of the drug-target residence time model 10 years ago (1,2), binding kinetics have become an important enhancement to “classical” drug discovery metrics (such as potency) when it comes to making compound progression and candidate selection decisions. This paradigm shift has been backed by retrospective analysis of recently approved drugs showing that nearly one third act via non-equilibrium mechanisms (3), and by studies suggesting that the incorporation of in-vitro kinetic information in drug discovery programs could support better prediction...

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Enterprise software for efficient translational research in an increasingly complex regulatory environment

Presented at the 14th Annual Pharmaceutical IT Congress, London, UK

Achieving the vision of precision medicine is reliant to a large degree on translational research activities that require researchers to characterize and profile patients in order to understand their response to new therapies, stratify patients for trials or search for new disease biomarkers.
The process of translational and clinical research poses significant challenges for organizations, ranging from federation of large volumes of disparate genomic and phenotypic data, through generating meaningful conclusions from such...

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Novel Workflow Concepts to Manage Analysis of Terabyte-sized Biomedical Images Resulting from Current and Emerging Imaging Technologies

Presented at SBI2 High Content 2016 - 3rd Annual Conference, Boston, MA, USA

 

Adding to current image-based screening activities such as Digital Pathology (DP) and High-Content Screening (HCS), new biomedical imaging technologies such as Mass Spectrometry Imaging (MCI) and various Single Plane Illumination Microscopy techniques are becoming commonplace in the field of preclinical drug discovery and development. These emerging technologies excel during the late Research & Development phases, allowing scientists to quantify drug efficacy, understand cellular mechanisms and drug mode of action,...

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New Platform for the Integrated Analysis of Bioreactor Online and Offline Data

Presented at The Bioprocessing Summit, Boston, MA, USA

The increasing use of downscale bioreactors in cell line and bioprocess development has led to a significant increase in the number of experiments being performed in a parallel. Such scale-down cell culture models are applied in clone selection, process optimization and for bioreactor upscaling campaigns. As a result, the amount of data that has to be stored, aggregated, visualized, and statistically analyzed has grown dramatically, and this has become the main bottleneck in the interpretation of the data. Here, we report on the...

Request Biologics, Cell Line Development
Automated Peptide Mapping for Quantitative Comparison of Biotherapeutics

Presented at The Bioprocessing Summit, Boston, MA, USA

Peptide mapping is an essential analytical technique for characterizing the primary structure of protein-based therapeutics. In bioprocess development, for instance, peptide maps are employed for lot-to-lot identity testing. Likewise, peptide mapping is considered a vital step in comparing an innovator and a biosimilar. Recent developments in separation techniques, MS instrumentation, and sample preparation procedures have allowed scientists to implement peptide mapping in their routine biotherapeutics characterization pipelines. While...

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Automated Data Analysis Enabling Mass Spectrometry–based Assays for the Developability Assessment of Biotherapeutics

Presented at The Bioprocessing Summit, Boston, MA, USA

Biotherapeutics candidates are selected not only for their biological activity, but also for their developability profile, a set of properties which give an indication of the risks and costs of technical development and manufacturing. A developability assessment performed at the beginning of the development phase is key to success, reducing the risk of investing resources on biomolecules that are difficult to develop or that pose huge technical challenges later, during formulation or production. The assessment is based on experimental...

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Genedata Bioprocess for Cell Line Developability & Manufacturability Assessment

Presented at The Bioprocessing Summit, Boston, MA, USA

In the process of development of novel biologics as therapeutic agents, the early assessment of their quality and developability is crucial. Therefore, more and more analytics methods are being applied in biopharma development workflows. In parallel, data management systems are needed to help scientists keep track of the molecules and their quality attributes, as well as the molecules’ samples and their manufacturing process parameters and quality. The analytics parameters being tracked include not only biological data, such as...

Request Biologics, Cell Line Development
New Platform for High-throughput Cell Line Screening and Development

Presented at The Bioprocessing Summit, Boston, MA, USA

The key aim of cell line development is the provision of stably expressing, high-yield mammalian cell lines for biopharmaceutical production. Recent progress in automation technologies, as well as new Quality-by-Design (QbD) approaches, have resulted in a very significant increase in experimental throughput. This, in turn, has led to a dramatic increase in the number of samples and associated analytics data that need to be processed, analyzed, interpreted, and reported across the whole CMC/Pharmaceutical Development organization. Here, we...

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A Software Platform for Improved Automated Clone Selection Based on Targeted Sequencing

Presented at The Bioprocessing Summit, Boston, MA, USA

Using targeted sequencing to validate integration sites, insert integrity, determine monoclonality and select the right clones requires an advanced bioinformatics solution with proper reference genomes. Addressing these needs is the Genedata Selector™ platform which provides a fully automated sequence analysis solution to support targeted sequencing projects.

The flexible and customizable Genedata Selector workflow applies to different targeted sequencing approaches including (i) read alignment against genome and vector, (ii)...

Request Cell Line Development, Cell Line Engineering, NGS, Strain Development
Machine Learning and Data Mining Techniques for Phenotypic Screening

Presented at the SLAS High-Content Screening Conference, Dresden, Germany

Analysis of image-based high content screens typically starts with automated image analysis followed by processing and analysis of the extracted numerical data. This data analysis workflow often consists of three canonical steps: a) ensuring result integrity through appropriate QC procedures and result comparability through data normalization, b) definition of the final activity or potency of individual compounds based on a single or a few HCS readouts, and c) generation of hit lists by simple filtering rules.

While...

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Epigenome-wide discovery of DNA methylation biomarkers for liquid biopsy-based ovarian cancer screening

Presented at the Festival of Genomics, Boston, MA, USA

Breast and ovarian cancers pose huge and still largely unsolved challenges for the medical profession. Most women with screening-detected breast cancer do not receive a clear treatment benefit, indicating that these cancers are still not being detected early enough. The less common ovarian cancer is often not diagnosed until in an advanced stage, resulting in a five-year survival rate of less than 40%. New tests based on genomic biomarkers have the potential to offer, for the first time, much earlier detection and diagnosis of ovarian...

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Genedata Bioprocess for High-throughput Cell Line Screening and Development

Presented at Cell Culture Engineering, Palm Springs, CA, USA

The key aim of cell line development is the provision of stably expressing, high-yield mammalian cell lines for biopharmaceutical production.  Progress in automation technologies, as well as new Quality-by-Design (QbD)  approaches, has resulted in a significant increase in experimental throughput. This has led to a dramatic increase in the number of samples and associated analytics data that need to be processed, analyzed, interpreted, and reported across the whole CMC/Pharmaceutical Development organization. Genedata BioprocessTM ...

Request Biologics, Cell Line Development, Cell Line Engineering
Data-driven Antibody Engineering

Presented at PEGS, Boston, MA, USA

Biopharmaceuticals are the drugs of the future, but their generation, design, and engineering is complex and expensive. Gaining a better understanding of the factors behind the efficacy, expressibility, stability and immunogenicity of biopharmaceuticals is crucial to improve protein engineering and reduce development timelines and costs. Here we present a novel informatics platform for antibody screening, engineering, and production, that enables researchers to integrate and visualize sequence (CDR compositions, AA residue distribution, PTMs, etc.),...

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New Platform for Antibody Developability and Manufacturability Assessment

Presented at PEGS, Boston, MA, USA

In the process of discovery and development of novel biologics as therapeutic agents the early assessment of their quality and developability is crucial. Therefore, more and more analytics methods are being applied on an increasing number of drug candidates in earlier stages of the biopharma R&D workflows. In parallel, data management systems are needed to help researchers keep track of the molecules, their samples, and their characteristics. The analytics parameters being tracked include not only biological data such as bioactivity, but also physicochemical...

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New Platform for High-throughput Surface Plasmon Resonance (SPR) analysis for antibody screening and characterization

Presented at PEGS, Boston, MA, USA

The discovery of monoclonal antibody drugs is a complex and costly exercise. Reducing product cycle time and improving the lead quality early in the R&D process is essential for successful development of new biotherapeutic drugs. This requires earlier and more detailed evaluation of increasingly large panels of biomolecules, derived from any display, hybridoma, or B cell technology.

Surface Plasmon Resonance (SPR) and related technologies, e.g., Biolayer Interferometry (BLI), are routinely used to efficiently study macromolecular interactions such as...

Request Hit & Lead Identification, HTS, Label-free, Surface Plasmon Resonance, Biophysics
Genedata Bioprocess for the Integrated Analysis of Bioreactor Online and Offline Data

Presented at Bioprocess and Cell Line Development, Vienna, Austria

The increasing use of downscale bioreactors in cell line and bioprocess development has led to a significant increase in the number of experiments being performed in a parallel. Such scale-down cell culture models are applied in clone selection, process optimization, and for bioreactor upscaling campaigns. The amount of data that has to be stored, aggregated, visualized, and statistically analyzed has grown dramatically. Our newly developed platform enables the automatic capture of all online and offline data (e.g., pH, O2,...

Request Cell Line Development, Cell Line Engineering, Biologics
A New Biologics Registration Platform - Fully Integrated with Large Molecule Discovery Workflows

Presented at Bio-IT World, Boston, MA, USA

The discovery and development of large molecule therapeutics is fundamentally different from the small molecule, chemical R&D process. Biomolecule registration requires comprehensive documentation of all development and production parameters along the R&D process, including cell lines, vectors, or expression and purification protocols. Here, we present a new registration platform, developed together with major biopharmas, which enables registration and tracking of all biologic molecules and samples. It can handle complex pools and mixtures, as well...

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An Enterprise Software Platform to Leverage NGS and Genomics/Omics Data in Cell Line Development

Presented at the Cell Line Development Conference 2016, Vienna, Austria

The introduction of next generation sequencing and omics technologies has changed the way in which cell line can be designed, selected and optimized. With the new era of genome-based cell line design, selection and gene editing, we have seen that there is an immediate need for seamless data management, integration, analysis, and result sharing. Furthermore, complex experimental workflows may require different tools and are only partially supported by currently available solutions. To address this need, we have developed...

Request Cell Line Development, Cell Line Engineering, NGS, Omics, Statistical Analysis