Q Therapeutics, Inc (Q) announced that Goodwin Biotechnology, Inc (GBI), a subsidiary of Mumbai based Wallace Pharma, would manufacture a monoclonal antibody used by Q in purifying its cell therapy product, Q-Cells. GBI has already begun the process development.
This IgM antibody recognises a unique cell surface marker that is expressed on Q-Cells (neural glial cells). On successful completion of the production, Q Therapeutics would utilise the IgM antibody to manufacture the Q-Cells in accordance with the US FDA requirements at a cGMP production facility. Q Therapeutics would conduct phase I trials for the treatment of transverse myelitis, a rapidly paralysing subset of multiple sclerosis (MS), in 2009.
Q-Cells, the first product of Q, is a cell-based therapeutic intended to replace the insulating myelin and provide natural supporting factors to damaged neurons, thereby restoring or preserving normal function of those neurons. Q-Cells are applicable to a wide range of demyelinating diseases, including multiple sclerosis (MS), transverse myelitis, cerebral palsy, spinal cord injury and white matter stroke. They may also have application in other neurodegenerative diseases such as ALS (Lou Gehrig's disease) and Parkinson's disease in addition to serving as unique drug screening tools to identify other pharmaceutical products, said the company in a press statement.
"Selecting the right partner to manufacture this antibody was a critical decision we faced in preparing for our human clinical trials" said Deborah A. Eppstein, PhD, president and CEO, Q Therapeutics. GBI has already proven to be a terrific partner in meeting our technical, scheduling and business needs".
GBI specialises in process development and cGMP compliant mammalian cell culture manufacturing of bio-therapeutics for pre-clinical studies through phase III clinical trials.
"We are especially honoured to have been chosen by Q to assist them in development of this unique cell based therapy product, a therapeutic arena with tremendous potential," said Stephanie Finnegan, CEO, GBI.