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. Author manuscript; available in PMC: 2010 Sep 1.

Published in final edited form as: J Pharm Sci. 2009 Sep;98(9):3218–3238. doi: 10.1002/jps.21768

Incubation of mAb with microparticles in overfilled vials without headspace (method A). Panels A, B and C show mAb monomer as a function of time. Panel D shows soluble aggregates from incubations of mAb with stainless steel. Common to all panels: un-agitated control (μ); agitated control (ν). Panel A: mAb agitated with glass vials (); mAb agitated with glass syringes (); mAb agitated with sulfate-washed glass vials (). Panel B: mAb agitated with cellulose (). Panel C: mAb agitated with stainless steel (■); mAb agitated with stainless steel after passivation treatment (□), mAb agitated with Fe₂O₃ (). Panel D: soluble aggregates after agitation with stainless steel (■); soluble aggregates after agitation with stainless steel after passivation treatment (□). Data points are means ± SD for separate triplicate samples. Error bars may be obscured by symbols. Some symbols may overlay. The color version of this figure can be accessed in the online article.

Inline graphic — Incubation of mAb with microparticles in overfilled vials without headspace (method A). Panels A, B and C show mAb monomer as a function of time. Panel D shows soluble aggregates from incubations of mAb with stainless steel. Common to all panels: un-agitated control (μ); agitated control (ν). Panel A: mAb agitated with glass vials (); mAb agitated with glass syringes (); mAb agitated with sulfate-washed glass vials (). Panel B: mAb agitated with cellulose (). Panel C: mAb agitated with stainless steel (■); mAb agitated with stainless steel after passivation treatment (□), mAb agitated with Fe₂O₃ (). Panel D: soluble aggregates after agitation with stainless steel (■); soluble aggregates after agitation with stainless steel after passivation treatment (□). Data points are means ± SD for separate triplicate samples. Error bars may be obscured by symbols. Some symbols may overlay. The color version of this figure can be accessed in the online article.