Pharmaceutical composition of F(ab′)2 antibody fragments and a process for the preparation thereof

A composition comprising F(ab′)2 antibody fragments substantially free from albumin and whole antibodies and substantially free of pyrogens, wherein the composition binds to a purified antigenic molecule or a mixture of antigenic molecules found in snake venom, and wherein the F(ab′)2 antibody fragments are obtained by a method which comprises:

• (a) generating a source of antibodies from an animal that has been immunized with a mixture of antigenic molecules found in snake venom;
• (b) contacting the source of antibodies with pepsin under conditions to prepare an antibody digest containing F(ab′)2 fragments, wherein the antibody digest is substantially free of unhydrolyzed antibodies;
• (c) treating the antibody digest with two steps of ammonium sulfate precipitation, (i) one step at about 16% to about 22% weight by volume of ammonium sulfate, and (ii) another step at about 32% to about 38% weight by volume of ammonium sulfate, to thereby obtain a suspension containing F(ab′)2 fragments substantially free of whole antibodies;
• (d) centrifuging the suspension to produce a composition comprising a paste of F(ab′)2 fragments and a supernatant;
• and
• (e) removing the supernatant from the composition of (d).