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Track 7:Biopharmaceuticals and Biosimilars

Track 7:Biopharmaceuticals and Biosimilars

Biopharmaceuticals

Biopharmaceuticals (also called biologics) are drug products derived from living organisms, such as microorganisms, plants, or animals, using biotechnological methods. They are typically made from proteins, nucleic acids, or other biologically active substances, and they are often large, complex molecules compared to traditional small-molecule drugs.

Key Characteristics of Biopharmaceuticals:

1.      Production:

    • Biopharmaceuticals are produced through biotechnological processes, such as recombinant DNA technology, cell cultures, or fermentation. Examples include the use of bacteria, yeast, or mammalian cells to produce therapeutic proteins like insulin or monoclonal antibodies.

2.      Types of Biopharmaceuticals:

    • Monoclonal Antibodies (mAbs): Engineered antibodies used to treat diseases like cancer (e.g., Rituximab, Trastuzumab) and autoimmune diseases (e.g., Adalimumab).
    • Recombinant Proteins: Therapeutic proteins such as insulin, growth hormones, and erythropoietin (EPO), which are used for diseases like diabetes and anemia.
    • Vaccines: Biologically-derived products that stimulate the immune system to protect against infectious diseases (e.g., HPV vaccine, COVID-19 vaccines).
    • Gene Therapies: These include products that deliver or modify genetic material to treat genetic disorders (e.g., Zolgensma for spinal muscular atrophy).
    • Blood Products: Such as clotting factors for hemophilia or immunoglobulins for immune deficiencies.

3.      Administration:

    • Biopharmaceuticals are often administered via injection or infusion, as they are too large or unstable to be taken orally.

      Biopharmaceuticals

      Biopharmaceuticals (also called biologics) are drug products derived from living organisms, such as microorganisms, plants, or animals, using biotechnological methods. They are typically made from proteins, nucleic acids, or other biologically active substances, and they are often large, complex molecules compared to traditional small-molecule drugs.

      Key Characteristics of Biopharmaceuticals:

      1.      Production:

        • Biopharmaceuticals are produced through biotechnological processes, such as recombinant DNA technology, cell cultures, or fermentation. Examples include the use of bacteria, yeast, or mammalian cells to produce therapeutic proteins like insulin or monoclonal antibodies.

      2.      Types of Biopharmaceuticals:

        • Monoclonal Antibodies (mAbs): Engineered antibodies used to treat diseases like cancer (e.g., Rituximab, Trastuzumab) and autoimmune diseases (e.g., Adalimumab).
        • Recombinant Proteins: Therapeutic proteins such as insulin, growth hormones, and erythropoietin (EPO), which are used for diseases like diabetes and anemia.
        • Vaccines: Biologically-derived products that stimulate the immune system to protect against infectious diseases (e.g., HPV vaccine, COVID-19 vaccines).
        • Gene Therapies: These include products that deliver or modify genetic material to treat genetic disorders (e.g., Zolgensma for spinal muscular atrophy).
        • Blood Products: Such as clotting factors for hemophilia or immunoglobulins for immune deficiencies.

      3.      Administration:

        • Biopharmaceuticals are often administered via injection or infusion, as they are too large or unstable to be taken orally.