Wyeth

Janssen Alzheimer Immunotherapy

Donna L Luisi

Nicholas W Warne

Angela Kantor

Pilarin Elizabeth Nichols

The present invention provides formulations for maintaining the stability of A&#x3b2; binding polypeptides, for example, A&#x3b2; antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.

Anti A beta antibody formulation

Methods for reducing the opalescent appearance of a protein preparation by modifying the ionic strength of the preparation, as well as compositions, e.g., pharmaceutical compositions, of concentrated protein with decreased opalescence are disclosed. Purification methods which monitor and/or reduce the salt concentrations at selected steps are also disclosed.

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North Andover, MA, United States of America

Donna L Luisi