GlycoThera offers contract 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 - a GMP-certified Company
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.