Q Chip is developing a range of sustained release biosimilars using its Q-Sphera bioencapsulation platform.
Q-Sphera is an enabling technology for peptide and protein delivery and a lower cost formulation and production platform for biosimilars.
The first two drugs under development using the Q-Sphera delivery system are the biosimilars, Q-Leuprolide (primary indications in prostate cancer and endometriosis) and Q-Octreotide (primary indications in acromegaly, and palliative care).
Q-Leuprolide and Q-Octreotide are three- and one-month sustained release microsphere formulations respectively.
Q Chip's Q-Sphera technology offers several potential solutions to overcome the issues with biotherapy delivery, most notably via minimisation of protein and peptidal degradation and lower cost of production.
The Q-Sphera drug-loaded microspheres are produced using bioresorbable polymers, and at 80 microns in diameter are injectable using 27-29 needle gauge devices.
Encapsulation of biotherapies into bioresorbable microspheres enables sustained and improved drug delivery.
Q-Sphera is manufactured using Q Chip's bio-encapsulation platform, which eliminates many of the limitations of conventional pharmaceutical microencapsulation methods.
In particular, Q-Sphera microparticles are monodisperse with a CV (coefficient of variance) of less than two per cent.
Particle size influences drug-release characteristics and there is a direct correlation between consistent particle size and consistent drug release and therapeutic performance.
Q-Sphera microspheres also typically have a high drug load with a correspondingly high activity.
Q-Leuprolide and Q-Octreotide are in pre-clinical phase with bioequivalence studies planned for completion in 2011.
