Genedata Biologics

Selected Customer Presentations

Here is a sampling of conference presentations featuring Genedata BiologicsTM and the system's implementation and use at leading biopharmaceutical companies worldwide.

Kymab
Presented at PEGS Europe, November 2016, Lisbon, Portugal

Advances in Kymab’s Fully Integrated, B-Cell Repertoire Analysis and Hit Selection Capabilities
David Melvin, Ph.D., Director of Informatics, Kymab Limited

Kymab have developed an advanced technology to visualise and deeply explore the Kymouse™ antibody repertoire. We can identify candidate-quality molecules with exceptionally broad diversity and with the quality of fully human antibodies. Our platform allows rapid, detailed and efficient exploration of the B-cell response to immunisation as well as informing and supporting decision making process throughout our discovery program. We will present our work with the Bill and Melinda Gates foundation.

Bayer HealthCare
Presented at PEGS Europe, November 2016, Lisbon, Portugal

Development of an Automated Parallel System for Production of High-Quality Lead Candidate Antibodies – Keeping Pace with Researchers' Appetites
Lars Linden, Ph.D., Head, Protein Biochemistry, Bayer HealthCare

In early research, project teams profile multiple antibody candidates in functional and often cell-based assays. Within a growing portfolio, this leads to an increasing resource need for the production of mg amounts of high-quality antibodies. To meet this demand, transient transfection and expression were automated, a novel high-throughput 2-step chromatography system was set up, and an integrated automation concept for sample handling was developed.

Pfizer
Presented at PEGS, April 2016, Boston, MA, USA

Database Systems for Consolidation and Analysis of Biotherapeutic Molecular Assessment Results
Joel Bard, Ph.D., Senior Principal Scientist, Global Biotherapeutic Technologies, Pfizer

Global Biotherapeutic Technologies at Pfizer uses a number of biophysical and biochemical assays to predict the developability of early stage biotherapeutics. Data from these assays is used to remove sequence liabilities before they can cause problems in production. To improve access to this data and allow analysis across multiple projects, we have recently implemented a database to store these results and provided web applications to simplify its deposition and analysis.

Pfizer
Presented at Bio-IT World, April 2016, Boston, MA, USA

From Spreadsheets to a Centralized End-to-End Biologics Repository and Analysis Platform
Peter Henstock, Ph.D., Senior Principal Scientist, Research Business Technologies, Pfizer

The challenge described was the alignment of workflows and centralization of data for 200+ Pfizer scientists in 15 groups located at 7 sites. After an aborted earlier attempt with a develop-as-you-go approach, we decided to implement an infrastructure as the backbone platform and central repository of the biological workflows, complemented by a set of custom and proprietary tools used to capture specific instrumental data, workflows, analyses, and nuances of each group’s unique contributions to the overall biological drug discovery process. This talk will show examples of the ecosystem of tools developed and discuss what we learned in the process.

Bayer HealthCare
Presented at PepTalk, January 2016, San Diego, CA, USA

New Workflow Platform for High-Throughput Cell Line Development
Christian Bender, Ph.D., Computational Biologist, Global Drug Discovery, Global Biologics, Bayer HealthCare

We present a new workflow system automating the Cell Line Development process for mammalian cells used to produce therapeutic antibodies and proteins. It tracks clones produced and screened in high-throughput mode, collects relevant characterization data and streamlines high-throughput workflows by interfacing with automation equipment and bioreactors. We show how Bayer’s Global Biologics groups use it and present applications of the generation of GMP-ready cell lines and their transfer into process development.

GSK
Presented at PepTalk, January 2016, San Diego, CA, USA

Comprehensive System to Manage GSK’s Antibody Discovery Processes
Trevor Wattam, Ph.D., Manager, Biopharm Discovery Group, Biopharm Discovery Group, GlaxoSmithKline

GSK’s large-molecule research programs are based on a unique platform of antibody discovery technologies. To support and integrate the different screening, engineering and production processes, we have implemented a comprehensive R&D workflow system called the GSK’s Antibody Discovery Database (ADD). We will present how the ADD makes GSK’s lead discovery process more efficient, with use cases from GSK’s yeast and phage display as well as hybridoma and humanization processes. We will also present concrete applications showing how the ADD supports the design and engineering of novel lead candidates with improved properties, including domain antibodies (dAbs), fusion proteins, bispecifics and ADCs.

Bayer HealthCare
Presented at Cell Culture & Bioprocessing Congress, November 2015, London, UK

Cell Line Selection And Early Bioprocess Development: An Integrated Apporach For Optimal Clone Identification
Anke Mayer-Bartschmid, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

Development of a data management platform supporting the automation of the Cell Line Development (CLD) process for mammalian cells used to produce therapeutic antibodies and proteins. The system tracks all stably transfected clones screened in high-throughput mode, collects all relevant characterization data, such as productivity and quality parameters, and streamlines high-throughput workflows by interfacing with automation equipment and bioreactors. Cell cultivation data using small-scale ambr bioreactors to assess cell lines and to guide media selection and upscaling campaigns. We will show how our workflow system processes and analyses ambr online and offline data to identify the optimal clones for biologics production. How product quality data, such as glycosylation patterns, is integrated into the process and used for making informed decisions to choose which cell line to move forward with. Our integrated process helps to identify superior GMP-ready cell lines.

Bayer HealthCare
Presented at PEGS Europe, November 2015, Lisbon, Portugal

Cell Line Development and Early Bioprocessing: An Integrated Data Management Solution to Select the Right Clone
Claudia Götzberger-Schad, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

We present an integrated data management platform supporting the clone selection in the Cell Line Development (CLD) process. The system tracks all clones screened in high-throughput mode, collects all relevant characterisation data, such as productivity and quality parameters, and streamlines high-throughput workflows by interfacing with automation equipment and bioreactors at different scales. A special focus of the presentation will be on fermentation in small-scale bioreactors to assess quality and to guide clone selection and upscaling campaigns.

Bayer HealthCare
Presented at Bioprocessing Summit, August 2015, Boston, MA, USA

Biologics Data Platform for Tailored Support of Cell Line Development
Christian Bender, Ph.D., Computational Biologist, Global Drug Discovery, Global Biologics, Bayer HealthCare

We have successfully implemented the Biologics Data Platform (BDP) for tailored support of our screening and protein production processes. In the context of our cell line development process, we present the integration of BDP with our automation workstation. We demonstrate the power of using a comprehensive data management platform to track data for cell line clones and fed-batch experiments together with molecule information such as primary sequences and experimental results.

AbbVie
Presented at Antibody Engineering & Therapeutics, December 2014, San Diego, CA, USA

An Informatics Platform for High-throughput Design, Screening and Optimization of Bispecific DVD-Ig Molecules
Diana Bowley, Senior Scientist II, AbbVie Bioresearch Center


DVD-Ig proteins are dual-specific antibodies with great therapeutic potential. To scale up and automate Abbvie's DVD-Ig discovery campaigns, we have developed an informatics platform which supports the design, cloning, expression, and purification of large panels of DVD-Ig candidate molecules. This informatics platform also assesses the selectivity, cross reactivity, epitope binding, and stability. The system will enable the parallel engineering of 1,000s of DVD-Ig molecules via combinatorial design of V-domains, linker positions and lengths, and Fc chains.

GSK
Presented at PEGS Europe, November 2014, Lisbon, Portugal

GSK’s Antibody Discovery Database (ADD), a Comprehensive System to Manage, Share and Exploit Antibody Discovery Processes and Format Information
Trevor Wattam, Ph.D., Manager, Biopharm Discovery Group, Biopharm Discovery Group, GlaxoSmithKline

GSK has a unique combination of antibody discovery technologies. We will present an overview of a comprehensive R&D data management system referred to as theGSK’s  Antibody Discovery Database (ADD), a comprehensive system  used to manage, share and exploit the large amount of relevant and complex information from all our Antibody discovery processes (yeast display, phage display, hybridoma/humanization) and GSKs biopharm formats, including domain antibodies (dAbs), mAbs and bi-specifics.

Bayer HealthCare
Presented at Cell Line Development & Engineering, September 2014, San Francisco, CA, USA

Implementation of a Predictive Screening Strategy for Cell Cloning by Automation and Parallelization
Anke Mayer-Bartschmid, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

For the implementation of Bayer's new cell line development system a new automation friendly cell line development workflow was created aiming an enhanced predictivity for scale-up while enabling automated screening of high numbers of different clones. A compact flexible automation platform as key component with integrated data management connected to a Biologics data platform as well as a small scale bioreactor system was established.

Takeda
Presented at Bio-IT World, May 2014, Boston, MA, USA

Building the Biomolecules Management Platform
Monica Wang, Ph.D., Lead System Engineer, Project and Program Manager, R&D Systems

Building a comprehensive Biomolecules Management Platform is a very challenging task. We are building an enterprise solution to track individual biomolecules in different drug development workflows and visualize their relationships. This platform will improve user efficiency, data quality, data exchange and collaboration for both research and preclinical development departments.

AbbVie
Presented at Bio-IT World, May 2014, Boston, MA, USA

Implementation and Deployment of a Workflow Management System for AbbVie’s Antibody Engineering Groups
Ankita Bhan, PMP, Scientist Informatics, Scientific Informatics and Automation, AbbVie

In order to address the existing and anticipated needs of Antibody engineering groups across the sites at Abbvie, we need to deploy technology based platforms covering the next gen biologics research. Here, we will focus on the successful management of an implementation and deployment project for Abbvie’s antibody lead discovery group leveraging the solution offered by Genedata Biologics.

Bayer HealthCare
Presented at Bio-IT World, May 2014, Boston, MA, USA

Development and Implementation of a Biologics Data Platform
Kai Herrmann, Ph.D., R&D IT Project Manager, BBS-ITS-R&D-HCR-BIO, Bayer Business Services

Biopharmaceuticals are increasingly important in the market for new medicines as they provide many advantages over small molecule-based drugs. The discovery and development of biologics molecules such as monoclonal antibodies and recombinant proteins is a complex and time-consuming exercise, and differs substantially from established small-molecule R&D processes. Hence, totally new IT and data management concepts are required. Here, we report our experience over the last 5 years of developing and implementing an innovative turn-key solution for biologics R&D data management.  The goal of the new platform was to increase the number and throughput of large-molecule R&D projects, to establish a shared collaboration platform for data exchange, and to improve the quality of results. We present specific challenges encountered, such as process complexity and diversity, process changes, constant adoption to new discovery technologies, direct instrument and robotics integration, and roll-out and system adoption in a large, globally operating biopharmaceutical organization.

Bayer HealthCare
Presented at ELRIG Forum, March 2014, Darmstadt, Germany

A Fully Automated Process for Clone Screening & Selection in Cell Line Development
Claudia Götzberger-Schad, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

Automation platforms are an integral part along the antibody generation and development process in the Global Biologics organization at Bayer. The presentation will touch on automation in antibody screening and small-scale IgG production and focus on our recent achievements to support the generation of antibody production cell lines. A fully automated platform was implemented for parallelization and streamlining of the cell line development process with the goal to reduce overall project timelines. Parallel handling of up to six clone selection campaigns is achieved through a tailored integration of robotics hardware and advanced software modules.
 

UCB
Presented at Molecular Medicine Tri Conference, February 2014, San Francisco, CA, USA

Biological Registration Systems at UCB and How they Integrate into the Discovery Workflow
David Lee, Ph.D., Principal Scientist, UCB Pharma

The benefits of informatics-driven data management systems are well known in the small molecule therapeutics arena.Extending these systems to supporting biotherapeutics presents a number of challenges. We present a novel data management system, BioQuest, integrating bespoke and best in class software systems designed to capture and integrate NBE data at UCB. We will focus on registration systems,in particular on the antibody and non-antibody protein registration system based on the Genedata BiologicsTM platform.

MorphoSys
Presented at SLAS, January 2014, San Diego, CA, USA

YBase – A New Integrated Workflow Platform for High-Throughput Antibody Discovery
Biopharmaceuticals and specifically monoclonal antibodies play an increasingly important role in the market for new medicines. The discovery and development of biopharmaceuticals is a complex and time-consuming exercise. MorphoSys is making this more efficient and robust by standardizing and automating the underlying processes in order to scale-up R&D operations. Here, we present the development and implementation of an innovative turn-key solution called YBase which supports biopharma R&D workflow and data management, developed in collaboration with Genedata.  We present the specific challenges encountered, including process complexity and new technology support. Examples cover processes from antibody library generation and screening to protein engineering, expression, purification, and analytics. YBase was built on the Genedata BiologicsTM platform, utilizing a structured and agile development approach. The resulting YBase platform is a powerful resource that enables a very significant increase in the throughput of R&D projects, setting new standards for therapeutic antibody generation in the biopharma industry.

AbbVie
Presented at PepTalk, January 2014
, San Diego, CA, USA

An Antibody Engineering Platform for High-Throughput Candidate Screening, Engineering & Optimization
Lorenzo Benatuil, Ph.D., Senior Scientist,  Biologics, AbbVie Bioresearch Center

High-throughput selection and screening of large antibody libraries need a robust data management and analysis platform able to track sequence evolution and aggregate assay data for hit and lead selection. We will present use cases to highlight the impact of incorporating appropriate bioinformatics tools and information management system on antibody generation by AbbVie’s in vitro display technologies.

Bayer HealthCare
Presented at PepTalk, January 2014
, San Diego, CA, USA

Data Management and Automation of Protein Production Workflows in Biologics R&D
Christoph Freiberg, Ph.D., Senior Scientist, Cell and Protein Sciences, Bayer HealthCare

Our comprehensive workflow platform supports highly parallelized antibody and tool protein production. It uniquely integrates in silico cloning, construct annotation and molecule registration functionalities, while supporting automated and high-throughput evaluation of expression systems of different scales. The molecule’s historical record is faithfully recorded, from early discovery campaigns to engineering and late-stage development. A single system stores molecule hierarchies and associated key expression, purification and analytics data. We thus glean essential information for improving product quality and optimizing production processes.

AbbVie
Presented at Antibody Engineering & Therapeutics, December 2013, San Diego, CA, USA

Bioinformatics and Data Management During Antibody Affinity Maturation by Yeast Display
Lorenzo Benatuil, Ph.D., Senior Scientist,  Biologics, AbbVie Bioresearch Center

Sequences and data management and analysis during the selection and screening of three ~10^9 antibody libraries during an antibody affinity maturation by yeast display. We will present a new workflow platform that enables a significant increase in throughput in the generation and testing of optimized antibody molecules. Concrete use cases illustrating examples from HT Antibody screening & engineering. Examples will cover yeast / phage / mRNA display, and other Ab discovery technologies.

Bayer HealthCare
Presented at ESACT, June 2013, Lille, France

Implementation of a Predictive Screening Strategy for Cell Cloning by Automation and Parallelization
Anke Mayer-Bartschmid, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

Despite many advances and novel techniques, cell line development is often rate-limiting in the overall progress of a specific project. To save on overall project timelines, it is Bayer’s approach to push up cell line development into late research phase to have a high performing cell line ready before entering into clinical development. This comes at the expense of having to perform cell line development for multiple clinical candidates for a given project at the same time, with project load ever increasing as often observed in industry. To overcome these limitations the workflow has been optimized including a compact flexible automation platform as key component with integrated data management connected to our Biologics data platform. EXPERIMENTAL APPROACH: A new automation friendly cell line development workflow was created aiming at enhanced predictivity for scale-up while enabling automate screening of high numbers of different clones. Key steps were tested manually. The newly deigned workflow is being transferred onto a specifically designed automation platform.RESULTS AND DISCUSSION: The newly designed workflow was manually tested and yielded clones of good productivity. An automation platform consisting of different liquid handlers, a cell imaging system, an incubator, a cryo vial decapper and a robo arm was established. First test runs were successfully started. The automation enables an efficient high throughput cell line development process. Appropriate data management is employed to cope with the associated increase in complexity of several candidates/projectes in parallel screening programs. A stringent workflow has been devised which is amenable to automation and still compatible with predictive clone selection and early assessment of product quality attributes.

Bayer HealthCare
Presented at PepTalk, January 2013, San Diego, CA, USA

Automating HTP Antibody Engineering and Small Scale Production
Christoph Freiberg, Ph.D., Senior Scientist, Cell and Protein Sciences, Bayer HealthCare

We have implemented an automated HT biologics screening and an automated transient mg-scale antibody production process for the discovery, optimization and production of monoclonal antibody leads. We describe a typical workflow from Fab screening via IgG reformatting to IgG research material production with focus on data management supported by Genedata’s Biologics software solution.

UCB
Presented at PEGS Europe, November 2012, Lisbon, Portugal

Integrating High-throughput Biotherapeutic and Protein Reagent Expression
David Lee, Ph.D., Principal Scientist, UCB Pharma

Recent advances in cell line development and automation technologies enable the parallel expression of large numbers of biomolecules. We present a novel data management and workflow support system based on Genedata BiologicsTM which captures production and characterization data for both biotherapeutics and tool proteins. The system is optimized for high-throughput processes, spanning molecular biology, expression, purification, and analytics workflows. We will present use cases with emphasis on antibody expression.

UCB
Presented at Pharmaceutical IT Congress, September 2012, London, UK

Biological Registration Systems at UCB & How they Integrate into the Discovery Workflow
David Lee, Ph.D., Principal Scientist, UCB Pharma

The number and type of biotherapeutics being developed is increasing year on year. The benefits of informatics driven data management systems are well known in the small molecule therapeutics arena. Extending these systems to supporting biotherapeutics presents a number of challenges. We present a novel data management system, BioQuest,integrating bespoke and best in class software systems designed to capture and integrate NBE data at UCB. We will focus on registration systems, in particular on the antibody and non-antibody protein registration system based on the Genedata BiologicsTM platform.

Bayer HealthCare
Presented at PEGS, May 2012, Boston, MA, USA

Implementation of a Fully Automated High-Throughput Antibody Engineering Process
Christoph Freiberg, Ph.D., Senior Scientist, Cell and Protein Sciences, Bayer HealthCare

We have implemented an automated HT-biologics screening process for the discovery and optimization of monoclonal antibody leads. We will describe discovery and optimization of monoclonal antibody leads. We will describe examples of our laboratory workflows from Fab screening to lgG reformatting with focus on data management support using Genedata’s Biologics software platform.

Bayer HealthCare
Presented at PEGS, May 2011, Boston, MA, USA

A Novel Integrated Data Management Platform for Biologics R&D
Christoph Freiberg, Ph.D., Senior Scientist, Cell and Protein Sciences, Bayer HealthCare

We have implemented an enterprise-level software solution together with our partner Genedata to comprehensively support biologics R&D activities.  We show how we have integrated all steps from HT biologics screening to cell line development into one workflow.