Monoclonal Anti-D – is it Safe, will it Work and can it Replace Polyclonal Anti-D?
(15) In 1991 the guidelines authors hoped that an effective monoclonal anti-D would soon be available to supplement polyclonal anti-D and that there would be sufficient quantities to allow antenatal prophylaxis to be started. In 1997 it appears that: (a) Monoclonal preparations, of which supply would be theoretically limitless, could in principle replace polyclonal anti-D. (b) Only Phase I trials are at present complete on monoclonal preparations. It is not yet certain if these preparations will be safe and efficacious, reliable or affordable. There may be advantages from an intravenous preparation that can also be given intramuscularly. (c) It is also uncertain how long it will be before monoclonal products are available in sufficient quantity, and whether they will be acceptable to regulators. (d) The process of introducing monoclonal products and possibly phasing out polyclonal anti-D will need to be agreed nationally, and will require a comparative trial. Polyclonal products should
