Technologies

With GlycoExpress, Glycotope has developed and is continuously expanding one of the most potent platforms for the development and high-yield production of glycosylated therapeutic proteins.

Background

Glycosylation is a form of post-translational modification, where complex carbohydrate (sugar) structures are attached to a protein by the host / production cell lines, which are currently at best of rodent origin (chinese hamster ovary or mouse hybridoma). Regarded irrelevant for a long time, glycosylation has undergone a shift to the centre of scientific and commercial attention due to the enormous influence the composition of these sugar structures yields on biologic and clinical properties of proteins and vaccines, including (but not limited to) activity, half-life time and immunogenicity (i. e. the potential for a therapeutic to be regarded as foreign by the immune system with subsequently even severe side effects).

A fully human system

Hamster and even more so murine glycosylation both differ from human glycosylation in several aspects. Controlled modification of the glycosylation by GlycoExpress hence allows a manifold improvement of existing (and new) biotherapeutics. As a consequence, lower dosing requirements will lead to an enormous economic benefit. A manifold improved activity in turn permits an improved treatment outcome or even the treatment of patients that so far did not respond to existing treatments. While most existing therapeutics are produced in rodent or hamster derived cell lines, GlycoExpress consists of a set of fully human cell lines. Hence the glycosylation (whose nature depends on the production cell line, not the DNA sequence of the protein) is also a fully human glycosylation with a drastically reduced likelihood of being regarded as foreign by the human immune system. Immunogenic side effects of biologic treatments, that lead to either inactivation of the protein or additional complications for the patient are largely eliminated.

Regulatory Aspects:

With Glycotope´s current clinical pipeline of 3 antibodies and 1 follicle-stimulating hormone, GlycoExpress has repeatedly been approved by regulatory authorities throughout Europe. Unlike other systems used for the alteration of the glycosylation of mainly antibodies, GlycoExpress is the only system suitable for all glycosylated proteins, which represent app. 80% of the proteome.

In addition, development in GlycoExpress permits a renewed patent protection.