Injectable Sustained Release Formulations of Therapeutic Proteins
The study is designed to evaluate Q Chip’s Q-Sphera™ peptide and protein delivery platform to develop a new sustained release microsphere formulation composed of biocompatible polymers loaded with interferon alpha 2a manufactured from ARTES´ proprietary yeast Hansenula polymorpha expression system.
Q-SpheraTM is a highly enabling bio-encapsulation technology for the development of polymer based sustained release systems. No harsh solvents or manufacturing conditions are used in the production of drug (including peptides and proteins) loaded microspheres facilitating benign processing of labile molecules.
Hansenula based products, which are already marketed worldwide, are characterized by safety and cost efficiency superior to other microbial technologies. Interferon alpha 2a manufactured from Hansenula has proven to be better tolerated than the E. coli reference.
The collaboration aims to improve patient compliance and provide a more convenient dosing schedule compared with current marketed pegylated therapies through the development of a one month sustained release microsphere formulation. This first phase of the collaboration is expected to be completed by the end of 2010.
ARTES Biotechnology GmbH – www.artes-biotechnology.com
ARTES is a Germany-based biotechnology company specialized in recombinant protein production from yeast expression systems. ARTES offers generation of optimized production cell lines and processes from the proprietary yeast expression systems Hansenula polymorpha and Arxula adeninivorans. In addition to genetic engineering, the company provides fermentation and downstream process development, analytical assay development and production cell line characterization. ARTES operates worldwide from its 850 sqm S1 facilities in Langenfeld near Duesseldorf. The company focuses on contract R&D for white and red biotechnology products.
Q Chip Ltd – www.q-chip.com
Q Chip is a UK based biopharmaceutical company specialising in the development of sustained release peptide and protein therapeutics using its proprietary Q-SpheraTM bioencapsulation platform. In 2004 Q Chip developed the world’s first fully-functioning MicroPlant™ platform for the production of commercial volumes of uniform, precisely-loaded microcapsules using a wide range of biocompatible polymers. Q Chip encapsulates pharmaceutical drugs into injectable microspheres for treatment of chronic diseases and cancers. Q Chip is developing two generic drugs, Q-Leuprolide and Q-Octreotide, for cancer treatment.