Dr. Claudia Götzberger-Schad, Bayer HealthCare AG, Wuppertal, Germany

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.

Dr. Dagmar Zunner, Molecular Devices (Germany) GmbH, Biberach at the Riss, Germany

Cloning and subsequently screening for biotherapeutic agents is a labour intensive and time consuming workflow. To increase the quality and efficiency of your screening and reduce labor and time requirements, Molecular Devices offers automated clone picking systems for mammalian, bacterial and yeast cells. These systems have been added to the product portfolio after the merger of Molecular Devices with its former sister company Genetix. Provided with imaging software, specific algorithms for screening are applied to ensure the picking of high quality clones. Furthermore, specific methods can be programmed and implemented to bring your manual workflow to a greater level of automation.

Dr. Axel Johann, Promega, Mannheim, Germany

Traditional ADCC bioassays suffer from donor primary NK effector cell variability that can complicate interpretation of Fcgamma RIIIa variant-specific ADCC efficiencies in such comparisons.  At Promega we have focused on developing high performance bioassays that ease transferability to QC lot release and stability bioassays.  Our ADCC bioassays are bioluminescence-based, simple, and homogeneous.  Cells in bioassay kits are ‘cell reagents’, in frozen, thaw-and-use format and ready for immediate use in the bioassay and thereby reducing assay variability to an minimum. ADCC Reporter Bioassays (V158 and F158 versions) are optimal surrogates for classic cytolytic ADCC bioassays.

Dr. Del Trezise, Essen BioScience, UK

Generating and validating antibody producing cell lines is a critical step in bio-therapeutic discovery and production. Here we describe the application of label free, non-invasive kinetic live cell imaging methodologies to the selection and quality control of cell lines. Using IncuCyte Zoom, an imaging microscope that resides in a standard cell incubator, measurements of cell proliferation rates and verification of mono-clonality can be made in real time during the cell dilution and expansion stages.

Oliver Graf, Novartis, TRD-Biologics Process R&D, Basel, Switzerland

Despite the large diversity in the biological properties of Biologicals (e.g. antibodies or antibody fragments) their physicochemical quality parameters can often be assessed by platform test methods. For typical parameters like the charge variant profile by ion-exchange chromatography, the size-variants by size exclusion chromatography (SEC) or capillary gel electrophoresis (CE-SDS) and even the profile of N-glycans it is common practice to apply generic platform methods. Such standardization of analytical testing of different Biologicals offers significant synergies. Repetitive hands-on operations like sample dilution steps and preparation of comparison solutions can be automated.