Biopharmaceutical

Biopharmaceuticals include therapeutic preparations such as proteins, antibodies and DNA preparations. Unlike chemically synthesized drugs, most biopharmaceuticals are highly complex molecules produced through a multistep manufacturing process in living systems such as microorganisms, animals or plants. A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Analytical testing is also one of the critical steps toward achieving a successful biosimilar (follow-on biologics) approval. Analytical testing provides the information needed to produce a safe and effective biopharmaceutical product, and the efficacy or safety depends on a product’s critical quality attributes (CQA).