The Impact of Syringe Age Prior to Filling on Migration of Subvisible Silicone-Oil Particles into Drug Product

Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody Representative of Real-World Drug Products Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems

(2019) Nathan H. Joh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations

(2015) Carly Fleagle Chisholm et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins

(2015) Elena Krayukhina et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Biopharmaceutical formulations for pre-filled delivery devices

(2013) Jan Jezek et al.   Expert Opinion on Drug Delivery

Mechanistic Understanding of Protein-Silicone Oil Interactions

(2012) Jinjiang Li et al.   PHARMACEUTICAL RESEARCH

Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches

(2011) Advait Badkar et al.   AAPS PHARMSCITECH

Evaluation of the Effect of Syringe Surfaces on Protein Formulations

(2011) Sumit Majumdar et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Micro-Flow Imaging: Flow Microscopy Applied to Sub-visible Particulate Analysis in Protein Formulations

(2010) Deepak K. Sharma et al.   AAPS Journal

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

(2010) Satish K. Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution

(2009) Renuka Thirumangalathu et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions

(2009) D.Brett Ludwig et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2008) John F. Carpenter et al.   JOURNAL OF PHARMACEUTICAL SCIENCES