mAb Charge Variant Standard

Even though ion-exchange chromatography (IEX) with a gradient of increasing salt concentration is frequently employed for charge variation profiling of mAb-based therapies, it frequently necessitates the development of improved procedures for each unique sample. A well-designed pH gradient approach, on the other hand, has the promise of being adaptable to a wide range of samples. The mAb Charge Variant Standard was established by WatersTM to assist this application area. It can be applied to system appropriateness, instrument and laboratory proficiency testing, and benchmarking LC procedures. The reference material should be utilized with BioResolveTM SCX mAb, 3 m Columns (either with or without the VanGuardTM FIT [Fully Integrated Technology] Cartridge), and BioResolve CX pH Concentrates.

When using the BioResolve SCX columns, this standard is specifically made to assist in benchmarking charge variant chromatography. It includes a special combination of whole proteins important to Biopharma's clients, including tryptophan, conalbumin, and the NIST RM 8671. (NIST mAb). Each batch of BioResolve SCX mAb materials is also quality-controlled using this standard. The mAb Charge Variant Standard should be dissolved in 100 µL of HPLC-grade water after being sterile filtered through a 0.2 µm sterile nylon filter unit.

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We recommend reviewing the MassPREP Protein Standard Mix as well; Ribonuclease A, Cytochrome c, bovine serum albumin, myoglobin, enolase, and phosphorylase b are all components of the MassPREP Protein Standard Mix. Different proteins with different isoelectric points, molecular weights, and hydrophobicities are present in this mixture. These features offer the user a desirable intact protein mixture that may be put to use in a variety of ways. Similar to the QCRM product line, it is advised that this standard be utilized frequently for testing column and system performance.