Extractables and leachables considerations for prefilled syringes

Biopharmaceutical formulations for pre-filled delivery devices

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

Determination of elemental impurities in leachate solutions from syringes using sector field ICP-mass spectrometry

(2013) K. Van Hoecke et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Silicone-Oil-Based Subvisible Particles: Their Detection, Interactions, and Regulation in Prefilled Container Closure Systems for Biopharmaceuticals

(2012) Flora Felsovalyi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2011) Advait Badkar et al.   AAPS PHARMSCITECH

Demonstrating the Stability of Albinterferon Alfa-2b in the Presence of Silicone Oil

(2011) Kristin B. Auge et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals

(2011) Jared S. Bee et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

(2011) Andreas Seidl et al.   PHARMACEUTICAL RESEARCH

On Developing a Process for Conducting Extractable–Leachable Assessment of Components Used for Storage of Biopharmaceuticals

(2009) Aditya A. Wakankar 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