Mass production of ready-to-use suspensions of fibrinogen-coated albumin spheres for the treatment of thrombocytopenic patients

A method of mass production of a composition comprising a suspension of albumin spheres by mixing ingredient solutions in batches, where the spheres are always in contact with an aqueous phase medium since their formation and have not been exposed directly to air, where said spheres remain completely in suspension and do not sediment after storage for at least six months, said method comprising the steps of:

• a) dissolving albumin molecules in an aqueous solution without the presence of a surfactant or detergent;
• b) adding a crosslinking agent to said aqueous solution to form a mixture which results in a concentration of said crosslinking agent that is insufficient for complete crosslinking of spheres by said crosslinking agent;
• c) adding a first portion of a desolvating agent to said mixture which results in a concentration of said desolvating agent insufficient to cause persistent turbidity of said mixture;
• and
• d) adding a second portion of said desolvating agent to said mixture after a waiting period which results in a combined concentration of said desolvating agent sufficient to cause formation of spheres stable against redissolving and without formation of aggregates.