Support of Anti-CD20 Monoclonal Antibodies
Sep 09 2013
Charles River has a range of services to support our clients’ biosimilar development programs, from GMP facilities for performing characterization and lot release testing through in vivo preclinical studies and support assays for both preclinical and clinical sample analysis. Combining the experience across the company, we have developed a comprehensive program that can be used to support the development of anti-CD20 monoclonal antibodies.
Biosimilars, like their reference biologic products, are complex protein structures that are difficult to characterize. Therefore, a development program consisting of analytical and bioanalytical assays, pharmacology and/or toxicology studies in animals and clinical trials is often needed to show that biosimilars are highly similar to their reference biologic product. Production processes are highly complex, expensive and can be difficult to control, so it is essential to work with a provider that can perform the full development program while providing the control essential to product uniformity. For this program we use Rituximab (Rituxan®) as an example. Rituximab is a chimeric murine-human monoclonal IgG1 kappa antibody directed against the CD20 antigen, which is found primarily on circulating cells of the B lineage. The advice contained in this document is based on the class of drug, scientific experience and published guidance documents.
Charles River is a global company with expansive scientific expertise that can be used to guide clients from discovery to approval. The primary benefits of choosing Charles River for your biosimilar package are our wide range of services, unrivaled experience conducting biosimilar programs, and the continuity we can provide for your entire program.
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