Inhibition of therapeutic protein aggregation by cyclodextrins

Advances in molecular genetics and recombinant protein (rDNA) technology lead to an

increasing availability of protein-based biomolecules1. In contrast to conventional low

molecular weight synthetic chemical drugs protein drugs provide a relatively high specifity

and activity at low concentrations2. Therefore, today protein drugs represent a fast-growing

class of therapeutic molecules1,3. Protein-based drugs offer a multitude of new therapeutic

options, mainly for the treatment of severe and chronic diseases such as autoimmune or

cancer diseases2. However, with the increasing number of ¿new biologic entities¿ passing

through development and manufacturing and finally reaching patients, also unprecedented

challenges for the design of stable, safe and convenient formulations are encountered4.

The first obvious formulation challenge to be faced concerns the delivery of protein drugs.

Oral delivery ¿ which is generally the preferred and most widely applied route of drug

administration ¿ is not feasible with protein drugs.