Q Chip, a biopharmaceutical drug delivery company, is developing a range of sustained-release biosimilars using its patented 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 established 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 2%. Particle size significantly 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.
“Our Q-Sphera technology has been perfected over the last 2 years to effectively protect and deliver biological molecules in a very controlled way,” said Ken Powell, Q Chip’s Executive Chairman. “Although realistic about the challenges, we are highly optimistic that these trials will be a success because of the significant advantages compared to conventional methods of encapsulation.”
Filed Under: Drug Discovery