As personalized therapies have become a reality rather than a distant promise, the tools needed to ensure the quality of these medicines grow increasingly important. Regulatory guidances for personalized medicines are frequently a “work in progress,” evolving over time as the body of knowledge grows for ensuring that these therapies are safe and beneficial.
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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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When patients are administered biological treatments created from their own bodies - autologous regenerative medicines - every second counts. Quality and purity can’t be compromised. To ensure microbial contaminants are removed during the manufacturing process, rapid microbial methods are needed for cell therapy, tissue-engineered, and gene therapy products.
By the year 2020, biopharmaceuticals are estimated to account for 50% of the most successful pharmaceutical products. (1)(2) Biologics, such as recombinant therapeutic proteins, vaccines, blood components, and regenerative medicines are growing faster than any other segment of medicines. The transition from chemically synthesized small molecule drugs to biologically-based, large molecule medicines produced through living expression systems has required the pharmaceutical industry to rethink its approach to quality control and develop novel strategies for ensuring the safety and quality of medicines.
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.