Celonic Group
Lorena Ramos Vicente is a seasoned professional in downstream process development, currently serving as a Senior Scientist at Celonic Group since November 2018, where responsibilities include the development of customer projects from harvest to drug substance filling, scale-down model establishment, and tech transfer to GMP production. Prior experience includes roles at Vectura Group plc. as a pMDI Scientist focusing on protocol writing and formulation development, Novartis Pharmaceuticals as a Technology Support Specialist involved in process transfer and improvement initiatives, and Lonza Biologics Porriño as a Downstream Process Scientist providing technical support to biotech manufacturing. Earlier career experience includes an internship at Novartis working on in-vitro dissolution investigations and an internship at Kommunalen Wasserwerken Leipzig GmbH. Lorena holds a Postgraduate Master's degree in Chemical Engineering from the University of Zaragoza.
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.