Abstract: Methods of sterilizing biologics or biological components are disclosed wherein the biologic or biological component in solution or suspension form are formed using an annealing step during freeze drying so that a porous solid matrix which allows penetration of a sterilizing gas such as EtO to pass through. The annealing process decreases the particle size of lyophilized material as compared to other methods and provides a more uniform cake that is easy to reconstitute. In addition, the resulting lyophilized material made with the annealing step allows better penetration of the sterilizing gas for more effective and uniform sterilization of the material.

Abstract: Methods of sterilizing biologics or biological components are disclosed wherein the biologic or biological component in solution or suspension form are formed using an annealing step during freeze drying so that a porous solid matrix which allows penetration of a sterilizing gas such as EtO to pass through. The annealing process decreases the particle size of lyophilized material as compared to other methods and provides a more uniform cake that is easy to reconstitute. In addition, the resulting lyophilized material made with the annealing step allows better penetration of the sterilizing gas for more effective and uniform sterilization of the material.

Abstract: Methods of sterilizing microparticles using a porous solid matrix which allows penetration of a sterilizing gas such as EtO to pass through are disclosed. The methods also include preparing a suspension of the sterilized microparticles by reconstituting the porous matrix containing the microparticles.

Abstract: Methods of preparing particles using a sonication device are disclosed. The methods include directing a particle forming solution containing a particle forming liquid and a particle forming agent as a stream into contact with a sonicating tip of a sonication device under conditions sufficient to transform the stream containing the particle forming solution into a plurality of droplets having a substantially uniform size. The plurality of droplets are contacted with a hardening solution under conditions sufficient to solidify the droplets into particles having a substantially uniform particle size which are then recovered. Particles made in accordance with the methods can be solid or semi-solid and range in size from sub-micron to over 100 microns in diameter.

Abstract: Compositions containing microparticles loaded with one or protease enzymes and optionally auxiliary therapeutic agents and methods of treating conditions such as keloids therewith are disclosed. The biodegradable polymer and the protease enzyme therein form a controlled release matrix for extended release of the enzyme after administration to a mammal in need thereof.