Highly complex biologics such as proteins, monoclonal antibodies, and cell and gene therapies increasingly fill biopharmaceutical pipelines across a range of therapeutic indications. These innovative biomedicines are introducing new challenges in monitoring and ensuring quality across the drug development workflow, from early stage research and discovery to clinical testing, regulatory review, manufacturing, and post-marketing surveillance.
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USP’s biologics blog delivers trends and insights impacting the development, manufacture and regulatory approval of biologics and biosimilars. Updated regularly, the blog covers a broad range of topics of interest to anyone working in the field of biopharmaceuticals.
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