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Recombinant human nerve growth factor for clinical trials: protein expression, purification, stability and
S J Allen1, A G Robertson, S J Tyler
1Molecular Neurobiology Unit, University Research Centre for Neuroendocrinology (Care of the Elderly), University of Bristol, BS2 8HW, Bristol, UK. shelley.allen@bristol.ac.uk
Abstract:
Nerve growth factor (NGF) has been suggested to be of therapeutic benefit to patients with Alzheimer's disease. One of the early changes in this disease is a loss of cholinergic function within the brain, and NGF is able to rescue cholinergic neurons both in vitro and in vivo. We describe the production of recombinant human beta-NGF (rhNGF), using baculovirus infection of insect cells; its purification, formulation and subsequent stability for use in clinical trials. Tests were also carried out to monitor release of protein from infusion pumps and catheters for intracerebroventricular administration (icv). Initial problems with non-specific binding were overcome using a blocking formula.