Charles River delivers client-focused solutions for the specific testing and manufacturing requirements of your biosimilar. A development program consisting of analytical and bioanalytical assays, pharmacology and/or toxicology studies in animals and clinical trials are required to show that biosimilars are highly similar to the reference biologic product. Biosimilar 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 for product uniformity.
Our experience working with biologics across the drug development continuum, together with our scientific and regulatory expertise, makes Charles River an ideal partner for your biosimilar development.