Opportunities and Limitations of Biopharmaceuticals

Biopharmaceuticals are attractive as drugs because they represent naturally derived products for treatment of disease. However, the complexities of the manufacturing process, and the drugs themselves, represent some major challenges in their development and formidable limitations to their widespread use. Even if biotechnology can now successfully produce large quantities of the pure protein, controlling its 3D structure during manufacturing, handling, and storage is critical to safety and efficacy. Delivering the protein to the patient in a safe, accurate, convenient, and reproducible manner is difficult. Even if these problems are overcome, the body often treats proteins differently than it treats small molecules, limiting their use.