Understanding and mitigating conductivity transitions in weak cation exchange chromatography

Fogle, Jace; Hsiung, Jenny

doi:10.1016/j.chroma.2009.11.099

Cited by 3 publications

(4 citation statements)

References 19 publications

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“…This provided encouraging results as this capacity is considerably higher than the reported capacity (22 mg/mL) of other cation exchange membranes for hIgG used in the bind/elute mode . It is also comparable to the performance of some weak cation exchange resins (48 and 89 mg/mL) . The Natrix HD‐C membrane also showed a significant amount of mAb binding (>50 mg/mL) at pH = 5 within a wide range of conductivities (8–15 mS/cm), which suggested high salt tolerance capacity.…”

Section: Resultsmentioning

confidence: 56%

“…It was noted that pH transitions occurred during the process (purple curve in Figure a) resulting in a prolonged wash 2 step (12 DV) and a small pH dip (∼0.3 pH unit) in the elution step. This was not surprising since pH shifts are commonly observed even in resin based weak cation exchange processes . One possible reason for this phenomena is that sodium ions have a higher affinity for the exchanging groups than hydrogen ions .…”

Section: Resultsmentioning

confidence: 88%

“…18 It is also comparable to the performance of some weak cation exchange resins (48 and 89 mg/mL). 19 The Natrix HD-C membrane also showed a significant amount of mAb binding (>50 mg/mL) at pH 5 5 within a wide range of conductivities (8-15 mS/cm), which suggested high salt tolerance capacity. This phenomena could be due to several aspects of the Natrix HD-C membrane such as ligand type (carboxyl), high ligand density, small pore size (0.3 lm) and its membrane matrix chemistry/structure (hydrogel), which all contributed to binding affinity and capacity.…”

Section: Dbc For Natrix Hd-c Membranementioning

confidence: 89%

“…This was not surprising since pH shifts are commonly observed even in resin based weak cation exchange processes. [19][20][21] One possible reason for this phenomena is that sodium ions have a higher affinity for the exchanging groups than hydrogen ions. 21 It was found that limiting the use of the sodium ions in the wash/elution buffer but increasing the buffer strength to maintain the required conductivity were helpful to reduce the buffer consumption for the wash 2 step and to control the elution pH drop to <0.3 pH unit.…”

Section: Laboratory Scale Purification Of Mab On Natrix Hd-c Membranementioning

confidence: 99%

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Advective hydrogel membrane chromatography for monoclonal antibody purification in bioprocessing

Hou

Brower

Pollard

et al. 2015

Biotechnology Progress

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Protein A chromatography is widely employed for the capture and purification of monoclonal antibodies (mAbs). Because of the high cost of protein A resins, there is a significant economic driving force to seek new downstream processing strategies. Membrane chromatography has emerged as a promising alternative to conventional resin based column chromatography. However, to date, the application has been limited to mostly ion exchange flow through (FT) mode. Recently, significant advances in Natrix hydrogel membrane has resulted in increased dynamic binding capacities for proteins, which makes membrane chromatography much more attractive for bind/elute operations. The dominantly advective mass transport property of the hydrogel membrane has also enabled Natrix membrane to be run at faster volumetric flow rates with high dynamic binding capacities. In this work, the potential of using Natrix weak cation exchange membrane as a mAb capture step is assessed. A series of cycle studies was also performed in the pilot scale device (> 30 cycles) with good reproducibility in terms of yield and product purities, suggesting potential for improved manufacturing flexibility and productivity. In addition, anion exchange (AEX) hydrogel membranes were also evaluated with multiple mAb programs in FT mode. Significantly higher binding capacity for impurities (support mAb loads up to 10Kg/L) and 40X faster processing speed were observed compared with traditional AEX column chromatography. A proposed protein A free mAb purification process platform could meet the demand of a downstream purification process with high purity, yield, and throughput.

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Section: Resultsmentioning

confidence: 56%

Section: Resultsmentioning

confidence: 88%