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Critical antibody reagents are used in regulated drug development settings and include both polyclonal and monoclonal anti-drug antibodies (ADAs), anti-idiotypic antibodies and anti-host cell protein (anti-HCP) antibodies. These antibodies work as ADA positive controls in immunogenicity assays, capture and detection antibody pairs in PK assays, neutralizing antibody (Nab) positive controls in Nab assays or capture and detection antibodies in HCP assays. These reagents are generated with extensive documentation, additional levels of characterization and often in larger quantities to last for the duration of the product's life cycle.
At Labcorp, we offer over 60,000 square feet of vivarium space, assuring rapid starts in any desired host species and dedicated tissue culture and immunochemistry lab enabling end-to-end solutions. To complete the solution, we offer long-term storage, characterization and management of your entire reagent portfolio through our Reagent Portfolio Management Solution.
ADAs
By partnering with the leading provider of custom ADA reagents, you will benefit from our scientific expertise in devising an appropriate strategy for your specific biotherapeutic and implementing risk mitigation steps to successfully generate high-quality reagents suitable for their intended purpose.
Regardless of the nature of your biotherapeutic, we offer customized strategies for antibody generation and purification based on over four decades of experience with the following therapeutics:
- Monoclonal antibody therapeutics
- Recombinant protein therapeutics
- Peptide therapeutics
- Oligonucleotides therapeutics
- Pegylated protein therapeutics
- Vector-based therapeutics
Anti-Idiotype antibodies
Generating anti-idiotype antibody reagents requires unique experience and scientific expertise. Our team has been providing these reagents for the last 45 years with hundreds of successful projects.
Given the complexities of generating anti-idiotypic antibodies for a specific purpose, we have perfected several approaches including polyclonal and monoclonal antibody generation strategies. These generation strategies include hybridoma development, B-cell cloning and a polyclonal anti-idiotype purification method.
- Polyclonal anti-idiotype antibody reagent
- Monoclonal anti-Idiotype antibody reagent
- Hybridoma cell line
- B-cell cloning
Anti-HCP antibodies
The majority of biotherapeutics are produced through recombinant DNA technology using various host cell expression systems. Despite complex and improved purification procedures to obtain highly pure biotherapeutic drugs, there is a high probability that a few host cell proteins (HCPs) copurify with the drug molecule. These contaminating HCPs have the potential to affect product safety, efficacy and quality of the drug product.
With over 1,000 potential HCP contaminates that can copurify with the final product, it is critical that we generate antibodies against the majority of these HCPs and use these respective reagents to develop highly specific assays. This necessitates a specific strategy that addresses the key considerations, which include antigen selection, host species, immunization paradigm, immune response monitoring, antibody purification and final characterization.
We can help you every step of the way with our custom reagent generation services and method development for anti-HCP assays:
- Custom antibody reagent development
- Assay development/validation (non-GxP and/or GMP )
- Routine testing (GMP)
- Assay transfer
