AVS 57th International Symposium & Exhibition
    Biomaterial Interfaces Thursday Sessions
       Session BI-ThP

Paper BI-ThP17
Surface Characterization of Baked-on Siliconized Vials for Biopharmaceuticals

Thursday, October 21, 2010, 6:00 pm, Room Southwest Exhibit Hall

Session: Biomaterial Interfaces Poster Session
Presenter: G. Torraca, Amgen, Inc.
Authors: G. Torraca, Amgen, Inc.
A. Vance, Amgen, Inc.
P. Masatani, Amgen, Inc.
L. Wong, Amgen, Inc.
B. Eu, Amgen, Inc.
M. Pallitto, Amgen, Inc.
M. Ricci, Amgen, Inc.
Z.-Q. Wen, Amgen, Inc.
Correspondent: Click to Email
Protein formulations have been found to interact with the glass container surface, resulting in protein adsorption, glass delamination, or glass dissolution. To mitigate surface interactions, alternative primary containers with chemically modified surfaces are actively investigated. One container coating technology that was studied utilized a method of coating the vial interior with a dilute emulsion of polydimethysiloxane (PDMS) and then baking the vials to form a durable layer. The baked-on layer is meant as an isolation layer that insulates the drug product from the glass surface to prevent glass degradation as well as product interactions. Baked-on siliconized vials from two primary container vendors were examined for changes in surface properties over a 6-mo stability timecourse. To better understand and compare representative samples, three analytical techniques were employed to study the interior surface of the vials. These were Polarized Light Microscopy, X-ray Photoelectron Spectroscopy (XPS) which is also referred to as Electron Spectroscopy for Chemical Analysis (ESCA) and Contact Angle Measurement. The baked-on PDMS layer of the vial container was determined to be incompatible with the formulations that were studied. The coating characteristics and the robustness of these coatings from each vendor are discussed.