Direct Visualization of Protein Adsorption to Primary Containers by Gold Nanoparticles

Cross-Linked Silicone Coating: A Novel Prefilled Syringe Technology That Reduces Subvisible Particles and Maintains Compatibility with Biologics

“…Silicone oil is also used to coat stoppers to facilitate handling and insertion into vials . Nonsmooth plunger motions arising from unsiliconized or improperly siliconized components may impact syringe functionality, autoinjector performance (when combined with a PFS), usability and compliance by the end user . However, recent studies have related silicone oil to protein aggregation and/or loss of soluble protein in some injectable formulations .…”

“…13 Nonsmooth plunger motions arising from unsiliconized or improperly siliconized components may impact syringe functionality, autoinjector performance (when combined with a PFS), usability and compliance by the end user. 1,14 However, recent studies have related silicone oil to protein aggregation and/or loss of soluble protein in some injectable formulations. 10,12,[15][16][17][18][19][20] Furthermore, silicone oil can slough off the syringe barrel and/or stopper during storage, which may be promoted by the various constituents of the formulation.…”

A container closure system that allows for greater recovery of radiolabeled peptide compared to the standard borosilicate glass system

“…Using a three step fractionation method (Blois et al, 2010) only the second 2mL of the eluant, which contained the highest 68 Ga concentration, was directed into a cyclic polyolefin copolymer CZ (Daikyo/West), or a standard United States Pharmacopeia Type I borosilicate glass CCS. The CZ and glass CCS chosen for this study meet the United States Pharmacopeia (USP), European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) requirements (Eu et al, 2011). Prior to the addition of the 68 Ga-chloride, the CCS was pre-filled with either a HEPES (4-(2-Hydroxyethyl) piperazine-1-ethanesulfonic acid, Sigma Aldrich), or sodium acetate (Sigma Aldrich) buffer formulation.…”

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

“…The amount of silicone oil on empty glass barrels (1×, 3×, and 6×) was quantitatively confirmed prior to filling using FTIR spectroscopy (data not shown). Silicone oil is considered to be evenly distributed on the cartridge glass on the basis of a consistent glide force value, as previously demonstrated in the literature, 17 measured using an Instron Force Gauge (Norwood, MA) as the plunger moved down the cartridge barrel (data not shown). In addition to glide force measurements, there are multiple in-process monitoring approaches that have demonstrated the uniformity of the silicone oil layer.…”

“…Studies have demonstrated that glide force testing is a means of assessing whether nonsiliconized (glass-exposed) areas are present on a syringe barrel. 17 Cartridges at all silicone oil application levels have consistent glide force values (measured using an Instron force gauge instrument, Norwood, MA) as the plunger moves down the cartridge barrel (data not shown). This suggests that the transfer of silicone oil into the product during lyophilization does not result in any nonsiliconized areas.…”