A Comparison of Multimodal Chromatography Resin: Case Study
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Transcript of A Comparison of Multimodal Chromatography Resin: Case Study
Mixed Mode Chromatography and KBI’s mAB Purification Process Platform• Mixed Mode resins are ideal for KBI’s mAb platform process since by the nature of
our business there is a significant diversity in mammalian cell clones/cell culture harvest and mAbs
• Mixed mode resins can provide added robustness to a mAb platform to reduce both HMW and HCP impurities
• Given the complexity of mixed mode resin interactions, optimizing a mixed mode chromatography step can be time consuming and potentially material limiting
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DS ProcessPlatform
Cell line diversity
Media/feed type
diversity
HCP level variability
Cell density variability
HMW level variability
Objectives• Determine if there is at least one mixed mode cation
exchange/hydrophobic interaction polishing step resin that performs well for multiple mAbs• Ideal candidates for a mAb process platform
• Present a high throughput, low material requirement method for identifying optimal operating ranges for multiple mixed mode resins in a single set of experiments• Show how the method can be use to identify optimal
chromatography conditions
• Show the relationship between the high throughput screening data and chromatography performance for different mAbs
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Mixed-mode cation exchange/hydrophobic interaction resins
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NuviaTM cPrimeTM
Bio-Rad Laboratories
MX-Trp-650MTosoh
EshmunoTM HCXEMD Millipore
CaptoTM MMCGE Healthcare
TM
High Throughput Screening: Plate Experimental Design
05/03/2023
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Variable Conditions Evaluated
Load pH 4, 5, 6, 7, 8
Elution pH 4, 5, 6, 7, 8
Elution [NaCl] (M) 0.20, 0.65, 1.10, 1.55, 2.00
• Three mAbs evaluated under a series of conditions• One plate executed per load pH
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• The low yield process condition zone size varies significantly with respect to resin, mAbs and process conditions and are easily identifiable
• In general, Capto MMC has slightly larger low yield zones for the mAbs and test conditions within our typical operating pH range .
• In general, each resin has a characteristic surface response map profile
Findings regarding the relationship between HT filter plate and chromatography data• High throughput filter plate data can be used to quickly
limit the focus of a chromatography evaluation using minimal amounts of the target protein• pH and NaCl conditions not favorable for high yields
are easily identifiable• There is a correlation between yield variability for each
condition (load pH and elution pH) and monomer selectivity• more variability leads to better selectivity
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