Core34: Characterisation of biological medicinal products

🧬 High-yield / 要点：Biological products are medical products made from proteins, sugars, nucleic acids, cells, tissues, or living systems. They are larger, more complex, and more immunogenic than small-molecule drugs.

What is a biological product? / 生物学的医薬品とは

• Biological products are medical products made from natural/biological sources.
• They may contain:
  • Sugars.
  • Proteins.
  • Nucleic acids.
  • Complex combinations.
  • Living entities such as cells or tissues.
• Like drugs, they can be used to:
  • Treat or cure disease.
  • Prevent disease.
  • Diagnose disease.

Examples / 例

• Botox：dermatologic and neurologic uses.
• Herceptin：specific type of breast cancer.
• Vaccines：e.g. influenza vaccine, shingles vaccine.
• Enbrel / etanercept：TNF-α inhibitor for rheumatoid arthritis and psoriasis.

Biologicals vs small molecules / 低分子薬との違い

Small molecule drugs	Biological products
Low molecular weight	High molecular weight
Usually chemical synthesis	Made with/from living cells or organisms
Fewer critical process steps	Many critical process steps
Well-characterized	Less easily characterized
Known structure	Structure may not be completely defined
Homogeneous drug substance	Heterogeneous mixtures; may include variants
Usually not immunogenic	Often immunogenic

Remember / 覚え方

• Biologics = big, complex, living-source products
• Manufacturing process strongly affects product
• More immunogenic and harder to fully characterize