CONTACT | LOGIN | REGISTER | HOME
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
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 (see ForteBio Tech Note 17: Dip and Read Immunogenicity Assay Kit for full details on the 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.
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.
ForteBio’s HCP assays allow Octet users to cost-effectively accelerate their research efforts and maximize the utility of their Octet system. Since no two HCP detection assays are identical, the custom services team will work closely with each customer to tailor each assay to the customer’s specifications using customer-defined capture reagents and analytes. All custom products are developed by ForteBio’s world-class product development group to deliver the best quality-controlled products possible for the Octet platform.
Host cell protein detection requires an assay that consistently delivers a broad, linear dynamic range, sensitivity to meet FDA guidelines, and unmatched reproducibility from each and every experiment. The Octet platform delivers consistency in quantitation unlike any other real-time detection tool available. Octet instruments use Dip and Read™ biosensors with specific capture antibodies immobilized on their tip surfaces to detect and quantify specific proteins of interest, including host cell proteins. The unique detection method employed by the Octet system provides the sensitivity, accuracy, and robustness required by this critical biotherapeutic assay.
Custom HCP detection kits contain biosensors and all the reagents required to quantitate customer-designated host cell proteins.
Key Features
For more information on ForteBio's custom HCP assays:
Don't see the assay you need? Visit our Custom Services web page to find out how ForteBio can make a custom assay just for you.
^ TOP
Copyright © 2010, ForteBio, Inc. All rights reserved.
PRIVACY POLICY | TERMS OF USE
