Genedata Bioprocess

Selected Customer Presentations

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

Sanofi Genzyme
Presented at ESACT, May 2017, Lausanne, Switzerland

Sanofi Cell Line Development: Data-driven Approaches for Cell Line Generation and Clone Selection
Michael Hoffmann,  Ph.D., Scientist, Cell Line Development Skill Center, Sanofi Genzyme

The development of production cell lines and optimal upstream processes has enormously been accelerated, amongst others, by introducing automation and parallelization such as the usage of scale-down bioreactor models and by applying more and more clone and product analytics methods. This symposium provides insights by experts from the biopharmaceutical industry about their ways of keeping track and analyzing the vast amounts of analytics data and process parameters and how their concepts look like to make data-driven decisions in the area of cell line and upstream process development. The presenters will illustrate their concepts with example case studies and will discuss about future outlooks and challenges on the use of data-driven approaches.

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.

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.

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.

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.
 

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. 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. 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.