Next-gen biopharmaceuticals

Protein biopharmaceuticals are rapidly increasing in scale and prevalence in modern medicine. In addition to classic monoclonal antibodies, the diversity of product types is diversifying to include enzymes, cytokines, blood factors, and subunit vaccines. These molecules often do not fit into platform manufacturing processes that are common for monoclonal antibodies. Discovery of products is often done without manufacturing in mind, resulting in protein sequences that can be difficult to manufacture. We define products as molecules that exhibit pre-defined efficacy, safety, and stability, independent of protein sequence. Small changes early on in the development of new products can have drastic impact on the manufacturability and quality of drug product. We demonstrate these ideas on a wide range of high-impact molecules, including vaccines, therapeutics, and antidotes for biological weapons. 

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