Recombinant human nerve growth factor for clinical trials: protein expression, purification, stability and characterisation of binding to infusion pumps

Nerve growth factor (NGF) has been suggested to be of therapeutic benefit t o patients with Alzheimer's disease. One of the early changes in this disea se is a loss of cholinergic function within the brain, and NGF is able to r escue cholinergic neurons both in vitro and in vivo. We describe the produc tion of recombinant human beta -NGF (rhNGF), using baculovirus infection of insect cells; its purification, formulation and subsequent stability for u se in clinical trials. Tests were also carried out to monitor release of pr otein from infusion pumps and catheters for intracerebroventricular adminis tration (icv). Initial problems with non-specific binding were overcome usi ng a blocking formula. (C) 2001 Elsevier Science B.V. All rights reserved.