Products

Protein A ELISA Kits

Repligen's Protein A ELISA Kits for detection of leached Protein A are chosen by biopharmaceutical companies for their easy-to-use procedure, quick run time, sensitivity and accurate results. Our kits are used in process development, process monitoring, and in final product testing to quantify natural, recombinant Protein A, and the MabSelect SuRe™* ligand contamination in samples eluted off of a Protein A chromatography column.

The combination of a specific capture system and an optimized sample diluent yields a highly sensitive assay able to accurately detect Protein A or SuRe™ in the presence of antibodies without the time and resources required for in-house assay development and optimization.

Immunological assays are the "gold standard" for quantifying Protein A, and it is well recognized in the quality organizations that for the most accurate results the best practice is to incorporate an internal standard [and spiking protein] that is most like the contaminant ligand. For this reason Repligen offers two distinct Protein A detection assays, each kit with its own unique standard:

  • one for the detection of natural and recombinant Protein A and
  • another for the detection of the GE Healthcare MabSelect Sure™ ligand.

NEW Protocols!

Dilute & Go - Speeds up and further simplifies our Protein A ELISA assay procedure by eliminating dialysis or buffer exchange for most sample matrices. This reduces sample preparation time, minimizes protein loss and makes the kits very easy to use!

Boil & Boost - Enables higher starting sample concentrations by incorporating a quick and easy 5 minute boil step to our Protein A ELISA assay procedure.  This allows end users to detect and quantitate low levels of leached Protein A without worry of diluting containment levels below the assay's LOQ.

Ease of Use:

  • Faster sample preparation
  • Minimize loss of protein
  • Optional adoption, no re-validation required
  • Ready-to-go "out of the box", no plate coating required
  • Plug and play for process development, process monitoring, and quality control
  • No individual reagent qualification
  • No methods development required

ELISA KIT – Detection of Leached Native and Recombinant Protein A

Repligen's Protein A ELISA kits have been used by technology leaders in our industry for over 10 years to ensure lot-to-lot consistency in monoclonal antibody and Ig fusion products. This kit is appropriate for processes that run columns that contain any Protein A resin (please see Protein A ELISA for detection of MabSelect Sure™ ligand).

Product Features Include:

  • Sensitivity of 0.1 ng/mL (0.8ppm)
  • Accuracy/Recovery ± 80-120%
  • Precision: Inter-assay 10%, Intra-assay 15%
  • Specificity for all variants of natural and recombinant Protein A
  • 2 hour assay completion time

Protein A ELISA Kit

ELISA KIT – Detection of Leached MabSelect SuRe™ ligand

Repligen's Protein A ELISA kits have been used by technology leaders in our industry for years to ensure lot-to-lot consistency in their monoclonal antibody and Ig fusion products.
For downstream processes that utilize GE Healthcare's base stable affinity media MabSelect SuRe™, Repligen offers the only kit on the market that includes the SuRe™ ligand standard for the most accurate spiking and recovery results.

Product Features Include:

  • Sensitivity of 0.1 ng/mL
  • Accuracy/Recovery ± 80-120%
  • Precision: Inter-assay 10%, Intra-assay 15%
  • Specificity for MabSelect SuRe™ ligand
  • 2 hour assay completion time

ELISA Kit - PZ

*MabSelect SuRe™ is a trademark of GE Healthcare companies.