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

Will be presented at the 18th Annual Drug Discovery Summit, Berlin, Germany

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...

Request HTS, Ion Channel Screening, Hit & Lead Identification, HCS, Compound Combinations, Biophysics, Surface Plasmon Resonance, Thermal Shift Assays
Fast and Accurate Assessment of Binding Kinetics in HTS Format with the Kinetic Probe Competition Assay and Genedata Screener

Will be presented at the 4th NovAlix conference, Strasbourgh, France

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...

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New Enterprise Platform for Biopharmaceutical Development & CMC

Presented at Bio-IT World 2017, Boston, MA, USA

The development process for large-molecule therapeutics is a complex task. Biopharmaceutical drugs are made of large, complicated, and fragile biomolecules that are produced in highly complex manufacturing processes. Novel therapeutic classes such as bi- and multi-specific antibodies, ADCs, and novel scaffolds pose additional challenges in expression, purification, analytics, and formulation development. Here, we present a new workflow platform for large-molecule development and CMC, which has been designed to make biopharma development...

Request Biologics, Cell Line Development, Cell Line Engineering, Mass Spectrometry, Statistical Analysis
A Software System for Next Generation Sequencing Based Detection of Adventitious Agents

Presented at the PDA Annual Meeting 2017, Anaheim, CA

The term adventitious agent generally describes bacteria, viruses, fungi, and other microorganisms that contaminate products produced using biotechnology. Current molecular methods for detecting adventitious agents require targeted probes for identification of small panels of known contaminants. Untargeted approaches like culture based assays require weeks to complete. NGS provides an untargeted and rapid method for identification of the nucleic acid content of all adventitious agents in a biological sample. A major challenge of using NGS...

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

Presented at ESACT 2017, Lausanne, Switzerland

With increased number of experiments performed in bioprocess development, the capturing, processing, aggregation, visualization, and statistical analysis of generated data has become a major bottleneck. Association of the data with the experimental context (e.g., fermentation protocols, media recipes, bioreactor control parameters) is also challenging in high throughput. New and highly performant data capture, rocessing, and analysis systems need to be integrated to enable processing of analytics data. We have developed a new platform for...

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Optimal Selection of Therapeutic Antibodies and Production Cell Lines by Assessment of Critical Quality Attributes and Developability Criteria

Presented at ESACT 2017, Lausanne, Switzerland

In the process of discovery and development of novel biologics as therapeutic agents a continuous 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...

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Evaluation of Large Panels of Bispecific Antibodies Using Surface Plasmon Resonance

Presented at the PEGS 2017, Boston, MA

Bispecific antibodies (BsAbs) have traditionally been developed by first optimizing antibody fragments then reformatting to the final bispecific format at the engineering stage. However, studies have shown that this method misses effective BsAbs. Moreover, costly engineering efforts are wasted optimizing BsAbs that once assembled turn out to be non-functional, unstable, or kinetically unsuitable. This is leading to a paradigm shift in BsAbs development: screening in the final therapeutic format as early as possible (“in-format screening”). This approach...

Request Surface Plasmon Resonance, Hit & Lead Identification, HTS, Label-free, Biophysics
Generation, Design and Evaluation of TCR-, TCR mimetic- and CAR-based Therapeutics for Cancer Immunotherapy

Presented at PEGS 2017, Boston, MA, USA

TCRs, antibody TCR-mimetics, CARs can provide significant advantages over traditional mAb approaches for the treatment of cancer.  However, as highly engineered entities, they pose new design, cloning, expression, purification, and analytics challenges. Our workflow platform, employed by top biopharma companies, enables the automation, engineering, production, and testing of large panels of these candidate therapeutic molecules. We demonstrate the platform’s high-throughput capability when handling novel molecule-specific designs and its built-in tools...

Request Biologics, Cell Line Development
High-throughput Screening, Design, Production, and Evaluation of Bispecific Antibodies

Presented at PEGS 2017, Boston, MA, USA

Work on bispecific antibodies has exploded and more sophisticated engineering approaches are now used. Concurrently, increasing numbers of bispecific platforms (e.g., tandem-scFv-Fc, DVD-Ig, diabodies) and parametric variants (e.g., linkers, V-domain orientation, Fc) must be tested. We present latest advances in our workflow platform for in-format screening (e.g., fully automated molecule design, DNA synthesis, and verification) and platform-specific expression processes (e.g., post production exchange reactions). Integrated into a comprehensive data...

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A Novel Integrated End-to-End Workflow System Enabling Increased Throughput in Bioprocess Development

Presented at Bioprocess International Europe 2017, Amsterdam, Netherlands

We have implemented a dedicated end-to-end platform to support the whole bioprocess development workflow. Co-developed in close collaboration with leading biopharmaceutical companies, the platform fully automates the cell line and scale-down upstream process assessment. In addition, the system manages upscaling, downstream process, analytical and formulation development, which enables the lineage tracking of all batches, starting from the transfection of a cell line all the way to the vials containing the final drug...

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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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Metagenomics Data Analysis and Management – Exploring Microbial Diversity

Presented at the Recent Advances in Microbial Control Conference, 2016

With the decreased cost of next generation sequencing (NGS) technologies, metagenomics is now a common tool in biological research. The study of microbiome genomics is especially challenging due to a lack of integrated computational solutions that support workflows from raw next-generation sequencing data to biological insight.

As a comprehensive and scalable software platform, Genedata Selector directly addresses the complex challenge of NGS data analysis and management. The system offers an end-to-end workflow that...

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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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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.


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