Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, has partnered with Q Therapeutics, Inc., a clinical-stage developer of novel cellular therapies for central nervous system (CNS) diseases to provide GMP antibodies for manufacture of clinical trial materials. To do so, Goodwin Biotechnology completed process development, scale up, and cGMP manufacturing of an IgM antibody and an IgM: ligand conjugate used in the isolation of Q-Cells, the first patented cellular therapeutic product candidate from Q Therapeutics under development for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.

“Q-Cells are glial-restricted progenitor cells (GRPs) – early descendants of neural stem cells that produce only ‘glia’ – which make up 50% of cells in the brain, and are essential for supporting, maintaining and even restoring neuron health. Based on the recently cleared investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA), we’re now on the cusp of performing groundbreaking human studies for the treatment of patients with ALS,” said Deborah Eppstein, president and chief executive officer, Q Therapeutics.

“This is an excellent example that utilized the breadth of our capabilities at Goodwin Biotechnology,” said Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. “The technical team at Goodwin prides themselves in all facets of this project and being able to minimize the potential aggregation, stability, formulation, bioconjugation, and purification issues associated with a hybridoma IgM monoclonal antibody reflects our solutions oriented approach that we apply to all projects. We are proud to have partnered with and provided consultation to Q Therapeutics over the last 6 years where we manufactured the IgM and conjugated the antibody with a ligand and leveraged the regulatory skill sets of our team to prepare the antibody portion of the CMC section for their IND submission.”     

Q Therapeutics selected ALS as the first clinical indication for Q-Cells based on a combination of the large unmet medical need and the significant scientific rationale supporting the multiple pathways by which healthy glial cells are believed to protect and preserve the function of motor neurons.