GlycoThera
Dr. Tobias Reinl currently serves as the Head of Quality Unit at GlycoThera since January 2025. Prior to this role, Dr. Reinl held multiple positions at Alvotech from November 2020 to December 2024, including Head QA R&D and Director QA Analytics R&D. Dr. Reinl's experience at GlycoThera also includes serving as Head of Quality Unit from March 2011 to December 2022, focusing on quality assurance and quality management in compliance with international GMP standards for biopharmaceuticals, particularly regarding glycoproteins. Earlier in Dr. Reinl's career, a role as QA-Manager and a Head of R&D in Cell and Molecular Biology was held at GlycoThera, alongside a postdoctoral position at Helmholtz Zentrum für Infektionsforschung from March 2008 to February 2011.
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GlycoThera
GlycoThera offers contract development & analytical services for all stages of biotherapeutics life-cycle management - from bench-scale development to large-scale product release and market supply - of recombinant human biopharmaceuticals (biosimilars, follow-on biologics, biobetters and innovative products) such as monoclonal antibodies, cytokines and hormones. Our clients are big BioTech companies worldwide and also start-up companies and medium sized BioTech enterprises. GlycoThera is based in Hannover (Germany) and GMP-certified since 2007 (re-certified in 2008, 2011 and 2014) for the quality testing of medicinal products according to ICH and EU guidelines. Thus, GlycoThera is under routine inspection by regulatory authorities and regularly audited by its clients. GlycoThera has a 12-years background in quality dossier submission to regulatory authorities (EMA, PEI, national authorities) and has been involved in the development of a number of biosimilar biopharmaceuticals leading to successful market authorisations. GlycoThera has contractual agreements with several companies to perform their market product batch release testing and guide them in various projects in clinical phases I, II and III. Based on the strong expertise of GlycoThera's scientific and regulatory management (> 25 years expert know-how), the company offers highest standards of reports and support in the preparation of submission files.