Celonic Group
Tobias Ostler has extensive experience in the biologics industry, with a particular focus on regulatory compliance and quality control. Tobias is currently a Senior Director of CMC Regulatory Compliance Biologics at Celonic Group. Prior to that, they worked at SGS as an Associate Director of Regulatory Compliance CMC Biologics from 2018 to 2022. From 2012 to 2018, Tobias was the Head of Biologics at Dr. Regenold GmbH. Tobias also held positions at Thermo Fisher Scientific and IBR Inc., Institute for Biopharmaceutical Research, where they led teams and worked on the development and validation of assays for clinical immunogenicity testing and non-clinical safety.
Tobias Ostler obtained their Doctor of Philosophy (PhD), Dr.rer.nat. degree in the field of Immunology from the Max Planck Institute of Immunobiology and Epigenetics, where they studied from 1999 to 2003.
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Celonic Group
Celonic is a global CDMO (Contract Development & Manufacturing Organization) for innovative biopharmaceuticals and is part of the private and independent family-owned company J.RETTENMAIER & Söhne (JRS Group), with sites in Basel, Switzerland (Headquarters) and Heidelberg, Germany. Celonic provides comprehensive development and manufacturing services for biotherapeutics, including cell line development, USP and DSP development, GMP and non-GMP manufacturing of biopharmaceutical drug substances. Celonic services covered: 2 INDUSTRY LEADING CELL EXPRESSION PLATFORMS: CHOvolution™: - Powered by Celonic's proprietary SEFEX™ technology - Cell line based on CHO-K1 (non-genetically modified CHO) - Cell line adapted to serum-free EMA and FDA compliant media - Simplified licensing model (no royalties from sales) - High productivity (>7 g/l for mABs) GEX®: - Human cells for fully-human glycosylation - Optimized for complex and sophisticated biopharmaceutical products - Stable product quality over full run-time for R&D and/or GMP - High productivity (up to 22g/l bioreactor volume for mAbs ) PROCESS DEVELOPMENT: - State-of-art USP and DSP development - Cutting-edge, in-house, and high throughput bioanalytics - Robust and scalable BIOMANUFACTURING CAPACITIES: - Two facilities (Germany and Basel) - Up to 2,000 L capacity batches in GMP and R&D setup - In-house analytics - Swissmedic GMP certified - 20 years of optimizing perfusion technique with >100 GMP batches NEW BIOLOGICAL ENTITIES : Celonic offers comprehensive approaches to enable clients to achieve commercial success, with a proven track record of developing breakthrough biologics and delivering GMP batches of ex. mABs, Growth Hormones, Fusion Proteins, and Blood Factors. BIOSIMILARS : Celonic offers ready-to-go Biosimilars (cell lines and cell pools—comprehensive analytics methods, comparability data, and development process) shaped on co-development and co-investment of next wave Biosimilars.