Avoid acid-induced aggregation in pH sensitive antibodies with MabSelect™ mild elution protein A resin. Lower aggregation means better yields and process economy in the capture step.
- Allows elution at pH ~5, reducing acid-induced aggregation and loss of target antibody.
- Specific Fc region interaction enables removal of product-related impurities from asymmetric bispecific antibodies (bsAbs) with protein A binding knocked out on one Fc region.
- Supports use in commercial-scale production, with a range of formats, good alkaline stability, high DBC, and regulatory support file.
Effective purification for antibodies sensitive to low pH
Typical elution pH values in the protein A capture step are in the 3.5-4 range. However, some antibody-derived molecules aggregate at this low pH—including bsAbs (containing an Fc region), IgG4, and Fc fusion proteins. Aggregation can compromise monomeric purity and yield and can place additional pressure on subsequent polishing steps. MabSelect™ mild elution resin is part of Cytiva’s toolbox of resins designed to solve a wide range of purification challenges and reduce the risk of unnecessary disqualification of molecules due to insufficient purification.
Specific interaction for the Fc region
MabSelect™ mild elution resin has a specific interaction with the Fc region of human IgGs. The resin can separate product-related impurities in the capture step for asymmetric bsAbs in which only one of the Fc chains includes the classical protein A-binding Fc-motif.
High DBC benefits process economy
High dynamic binding capacity (DBC) allows high mass throughput of processed antibody per resin volume unit. It also benefits productivity and process economy. At 6 min RT, the DBC for MabSelect™ mild elution resin is 60 g/L using trastuzumab. This is lower than the DBC of MabSelect PrismA™ resin (72 g/L), but for pH-sensitive molecules, higher elution pH may be more important than DBC.
Alkaline stability for robust resin cleaning-in-place (CIP)
MabSelect™ mild elution resin can maintain its DBC over many cycles, as well as withstand harsh cleaning conditions to reduce risk of bioburden incidents and carryover between batches. In a CIP lifetime study with repeated loading of mAb cell culture supernatant and cleaning with 0.25 M NaOH, the relative remaining DBC after 100 purification cycles was 82%. Even when cleaned with 0.5 M NaOH, the resin can be used for 100 cycles with more than 80% remaining DBC (shown in an accelerated alkaline stability study).
Formats
MabSelect™ mild elution resin is available in bulk in 25 mL, 200 mL, 1 L, 5 L, and 10 L containers. The resin can also be ordered in prepacked column formats, including HiTrap™ columns (1 mL and 5 mL), HiScreen™ columns, and on request in production-scale ReadyToProcess™ columns. These formats enable use from lab-scale to commercial-scale manufacturing.
Fig 1. Prepacked chromatography formats available from Cytiva to support various scales, from screening to GMP manufacturing.
Explore the mAb resin toolbox
Choosing the right capture resin starts with understanding your unique process. Factors like target molecule, impurity profile, process conditions, process volumes, number of batches, and cleaning protocols all influence resin performance. At Cytiva, we’re here to help you navigate these variables and find the right resins for your antibody and workflow, from capture to polishing. The protein A affinity capture step in antibody purification is followed by one or two polishing steps to remove impurities. Browse Capto™ chromatography polishing resins.
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