114
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`2 ng/ml rGH-CSF in D5W was used as a control. Each solvent additive was
`examined in triplicate at each concentration tested, and solutions were
`sampled at times 0, 0.5, I, 2, and 3 hr and assayed for rGH-CSF. A rapid
`adsorption was observed up to I hr, after which time a slower rate
`approaching steady state was observed, similar to adsorption reported for
`insulins and other proteins. Furthermore, viscometry was applied to
`estimate that the thickness of the adsorbed layer to glass was about I µm .
`Tween 20 at a concentration of 0.5% showed the most potential for
`inhibiting surface adsorption to parenteral glass vials.
`
`14.4. Binding to Filter Surfaces
`
`Proteins are known to bind to filter surfaces. Brose and Waibel (1996)
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`N66, Pall), and cellulose acetate (CA, Sartorius). They filtered 5-mg/ml
`solutions of proteins at pressures < I psi and measured protein concentration
`in the filtrate as a function of filtrate mass. The mass of adsorbed protein was
`determined by measuring the difference between theoretical (5 mg/ml = 0.5
`wt¾) and actual protein weight percent. This mass was divided by the
`membrane surface area (500 cm2) to obtain the amount of protein adsorbed
`per unit surface area. They found that both proteins adsorb to all filters, but
`the extent of adsorption is markedly affected by protein concentration and the
`type of filter (see Table XVII). Nylon filters adsorbed the most protein. BSA
`adsorption was linearly related to its concentration, with adsorption to nylon
`being twice as high as its adsorption to PVDF and CA membranes. lgG
`adsorption was linear, but very low to PVDF and CA filters, whereas its
`adsorption to nylon was extensive and nonlinear (it leveled off at higher
`concentrations). Other authors (Brose and Waibel, 1996) have also reported
`on protein adsorption on filter surfaces, so the phenomenon will occur, but the
`question is how much and how can the adsorption be minimized? The choice
`of filter, the concentration and type of protein being filtered, and the filtration
`conditions (pressure, rate, size offilter, etc.) all will affect the extent of protein
`adsorption to filters.
`
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