Formulations for highly purified viral particles

A pharmaceutical composition comprising a purified AAV particle, a pharmaceutically acceptable salt, a buffering agent, a cryoprotectant, and a non-ionic surfactant, wherein

• (a) the purified AAV particle is substantially free of an impurity,
• (b) the pharmaceutically acceptable salt concentration is about 1 mM to about 49 mM,
• (c) the buffering agent concentration is about 0 mM to about 50 mM,
• (d) the cryoprotectant is about 1% to about 10% (w/v), and
• (e) the non-ionic surfactant is about 0.0001% (w/v) to about 0.1% (w/v).

A pharmaceutical composition comprising a purified AAV particle, a buffering agent, a cryoprotectant, and a non-ionic surfactant, wherein

• (a) the purified AAV particle is substantially free of an impurity,
• (b) the buffering agent concentration is about 20 mM,
• (c) the cryoprotectant is about 5% (w/v) trehalose, and
• (d) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188.

A pharmaceutical composition comprising a purified AAV particle, a pharmaceutically acceptable salt, a buffering agent, a cryoprotectant, and a non-ionic surfactant, wherein

• (a) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 10 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• (b) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 25 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• (c) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 50 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• (d) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 100 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• (e) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 125 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• (f) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 150 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188;
• or
• (g) (i) the purified AAV particle is substantially free of an impurity,
• (ii) the pharmaceutically acceptable salt concentration is about 200 mM sodium chloride,
• (iii) the buffering agent concentration is about 20 mM,
• (iv) the cryoprotectant is about 5% (w/v) trehalose, and
• (v) the non-ionic surfactant is about 0.001% (w/v) poloxamer 188.

A method for making a pharmaceutical composition comprising a purified AAV particle, the method comprising:

• (a) contacting a supernatant comprising an AAV particle with a composition comprising a nuclease,
• wherein the nuclease optionally comprises Benzonase®, or Benzonase® and a chromatin-DNA nuclease, and
• wherein the chromatin-DNA nuclease optionally comprises a MNase;
• (b) purifying the AAV particle, such that the AAV particle is substantially free of an impurity;
• (c) combining the purified AAV particle with a buffering agent, a cryoprotectant, and a non-ionic surfactant, wherein
• (i) the buffering agent concentration is about 0 mM to about 50 mM,
• (ii) the cryoprotectant is about 1% to about 10% (w/v), and
• (iii) the non-ionic surfactant is about 0.0001% (w/v) to about 0.1% (w/v).