Patent ID: 8753839

Claim:
A batch crystallization method for the preparation of antibody crystals of a desired substantially uniform size range, the method comprising the steps of: a) providing an aqueous crystallization mixture having a pH of 4 to 6.5 comprising 0.5 mg/ml to 280 mg/ml of an anti-hTNFalpha antibody fragment, a polyalkylene polyol as a crystallization agent, and about 0.02 M to 0.5 M of a buffer under conditions that enable the formation of anti-hTNFalpha antibody fragment crystals, wherein the polyalkylene polyol is present in the crystallization mixture at a final concentration in the range of 5 to 30% (w/v) of the total volume; and b) agitating said crystallization mixture under controlled conditions, whereby said anti-hTNFalpha antibody fragment crystals having a needle-like morphology with a length of 2 to 500 μm and a length/diameter (l/d) ratio of 1 to 100 are formed, wherein said anti-hTNFalpha antibody fragment is MAK195F, which is a F(ab′) 2 fragment of antibody MAK195 produced by a hybridoma cell line having the deposit number ECACC 87050801.