Biopharmaceuticals are becoming increasingly important as novel therapeutics for human disease. Many of these products are proteins or biopolymers in which there is no extensive toxicology or pharmacology information or experience as biotherapeutics. Added to these are more usual treatments using cell-base or stem cell therapies.
Specialised testing using molecular biology and immunoassay techniques is available as well as animal models to evaluate immunogenicity and immunotoxicology.
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