The invention discloses a high-concentration
antibody preparation and application thereof, and belongs to the technical field of
antibody pharmaceutical preparations, the preparation takes an
antibody as an
active ingredient, adopts
glutamic acid and
histidine hydrochloric acid buffer solution, is matched with non-ionic saccharide and
sugar alcohol auxiliary materials, and uses a non-ionic buffer
system to maintain the pH value of the
system stable; and the stability risk caused by the ionic auxiliary material is reduced. The preparation can realize high-concentration preparation of more than 100mg / mL, obviously inhibits antibody aggregation, fragmentation and
oxidative degradation, improves purity, stability and injection convenience, and is suitable for
subcutaneous injection. The problems that a traditional high-concentration antibody preparation is prone to aggregation, high in
viscosity, poor in stability and the like are solved, the prescription is scientific and controllable, and the method is suitable for clinical transformation and large-scale production.