Surfaces Affect Screening Reliability in Formulation Development of Biologics

Catching Speedy Gonzales: Driving forces for Protein Film Formation on Silicone Rubber Tubing During Pumping

“…The dimensions of the clusters, around 100 nm, indicate that these clusters are formed by multiple antibody entities. 39 These large, irregularly-shaped agglomerate structures of the protein film have already been observed on various materials like glass, 9,40 graphite 41 and mica 42 . It is argued that these protein clusters originate either from sedimentation and adherence of larger protein particles from the bulk 40 , or from nucleation promoting the adsorption of further molecules.…”

“…39 These large, irregularly-shaped agglomerate structures of the protein film have already been observed on various materials like glass, 9,40 graphite 41 and mica 42 . It is argued that these protein clusters originate either from sedimentation and adherence of larger protein particles from the bulk 40 , or from nucleation promoting the adsorption of further molecules. 41,42 Interestingly, the clusters were only present at pH 5.4, whereas we obtained a smooth film at pH 7.4.…”

Effects of Transportation of IV Bags Containing Protein Formulations Via Hospital Pneumatic Tube System: Particle Characterization by Multiple Methods

“…Also, because of the foaming that occurs during PTS transportation of IVIG, for these studies we compared particle levels in the last few milliliters of solution in the IVIG bagwhich contain the foam --to levels from the non-foam containing earlier samples. Our hypothesis was that the air-water interface in the foam would cause particle formation and there would be relatively high levels of particles remaining adsorbed to the interface of the air bubbles 71,72,83,84,87,[107][108][109][110][111][112] .…”