Dip and Read™ Assay Kits

The immune system may respond to drug administration in patients by producing anti-drug antibodies (ADA) that can alter the pharmacodynamics and/or the pharmacokinetics of the drug. This makes immunogenicity testing (detection of these antibodies) an essential part of drug development. The Dip and Read Immunogenicity Assay Kit enables the detection of ADA as a part of an immune response to a protein or antibody therapeutic.

Key Kit Benefits

• Detect both high- and low-affinity ADA
• Minimize matrix effects
• Work with a wide range of free drug concentrations

The Dip and Read Immunogenicity Assay Kit offers the needed sensitivity, required drug tolerance, and flexibility to detect ADA by providing multiple protocols requiring no plate-washing steps. These protocols work with two different assay configurations: enzyme-linked bridging assays and direct binding assays. These assay formats work across the many drug types in the market today such as antibodies, proteins, and peptides, and can be used with both human and animal samples.

Protein A binds the Fc region of immunoglobulins, particularly IgGs. For this reason, Protein A is often immobilized onto a solid support and used to purify IgG from crude protein mixtures such as serum or ascites. During the purification process, Protein A can leach from the purification column and co-elute with the IgG. Protein A can cause adverse reactions in patients, therefore detecting and minimizing residual Protein A in products purified using a Protein A, or similar purification column is a critical quality control step in antibody therapeutic development and production.

Key Kit Benefits

• Quantitate Protein A or MabSelect SuRe™
• Sensitive and accurate assay
• Easy-to-use Dip and Read protocol
• Minimal hands-on time

The Dip and Read Residual Protein A Detection Kit contains biosensors and all the reagents required to quantitate Protein A, or biosimilars such as MabSelect SuRe, in column fractions. The Dip and Read Residual Protein A Detection Kit provides the sensitivity and accuracy needed for this critical test along with minimal hands-on time and an easy to use protocol.