The partnership targets Q Therapeutics’ biopharma candidate – named Q-Cells – which has received an Investigational New Drug Application from the FDA for the treatment of motor neuron disease (also known as Amyotrophic Lateral Sclerosis (ALS) and Lou Gehrig’s disease).
Goodwin Biotechnology has so far completed process development, scale-up, and cGMP manufacturing of Immunoglobulin M (IgM), the antibody used to isolate Q-Cells, as well as IgM’s ligand conjugate. IgM is a basic antibody produced by B cells; the largest in the human body.
“Q-Cells are glial-restricted progenitor cells (GRPs) – early descendants of neural stem cells that produce only ‘glia’ – which make up 50 per cent of cells in the brain, and are essential for supporting, maintaining and even restoring neuron health,” said Deborah Eppstein, CEO, Q Therapeutics.
Bioconjugation
Goodwin Biotechnology specialises in bioprocess development and GMP manufacturing of biopharmaceuticals using mammalian cell lines and bioconjugation – bonding mAbs and recombinant proteins to other molecules.
Muctarr Sesay, Chief Scientific Officer, Goodwin, said the technical team had overcome “potential aggregation, stability, formulation, bioconjugation, and purification issues associated with a hybridoma IgM monoclonal antibody.” Goodwin’s regulatory division also prepared the antibody portion of Q Therapeutics’ CMC (Chemical Manufacturing and Controls) section of its IND submission, he added.
Phase I-IIa trials of Q Cells are set to begin soon.
“This important milestone is a testament to the commitment and dedication of all of our scientific co-workers and supporters, that include the National Institute of Neurological Disorders and Stroke Translational Research Program (U01-NS06713) at the National Institutes of Health, the Maryland Stem Cell Research Fund, Bosarge Life Sciences, Nicholas Maragakis, MD, at Johns Hopkins University, MPI Research, Inc., the Biologics Consulting Group, and the Cell Therapy and Regenerative Medicine Facility (CTRM) at the University of Utah,” said Deborah Eppstein.