Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

Author:

Carpenter John F.,Randolph Theodore W.,Jiskoot Wim,Crommelin Daan J.A.,Russell Middaugh C.,Winter Gerhard,Fan Ying-Xin,Kirshner Susan,Verthelyi Daniela,Kozlowski Steven,Clouse Kathleen A.,Swann Patrick G.,Rosenberg Amy,Cherney Barry

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference16 articles.

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2. Effects of protein aggregates: An immunologic perspective;Rosenberg;AAPS J,2006

3. Urgent inhibitor issues: Targets for expanded research;Hooks;Haemophilia,2006

4. Mechanisms of action of immune tolerance induction against factor VIII in patients with cogenital haemophilia A and factor VIII inhibitors;Reipert;Br J Haemophilia,2007

5. Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation;Chi;Pharm Res,2002

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