Biopharmaceuticals overview

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matsuokn
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291580
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Biopharmaceuticals overview
Updated:
2014-12-14 18:56:02
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biopharmaceuticals overview
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  1. Biopharmaceutical
    A pharmaceutical inherently biological in nature and manufactured using biotechnology
  2. drug
    a pharmaceutical inherently chemical (not biological) in nature and manufactured using chemical methods
  3. Pharmaceutical
    a medicinal product (both active agents and formulated products) including therapeutics prophylactics and in vivo diagnostics, two major subsets are drugs and biopharmaceuticals
  4. 3 main examples of biopharmaceuticals
    proteins (including antibodies), Nucleic acids, Living microorganisms (including cells, virus, bacteria, even tissues)
  5. What was the major breakthrough in 1970?
    restriction enzymes that cut DNA at specific sites
  6. The joining of two DNA fragments by DNA ligase and produces a DNA molecule
    Recombinant DNA technology
  7. Polymerase chain reaction (PCR)
    way to multiply DNA quickly and efficiently
  8. What was the first FDA approved biopharmaceutical?
    recombinant human insulin
  9. what are the advantages in recombinant DNA?
    • 1. overcomes the problem of source availability
    • 2. Provides an alternative to direct extraction from inappropriate/dangerous source material
    • 3. cheap
    • 4. provide substantial quantity
    • 5. facilitates the generation of engineered therapeutic proteins displaying some clonal advantages over the native protein product
  10. what does ADME stand for?
    absorption, distribution metabolism and excretion
  11. how many phases are there in a clinical trial?
    4 phases
  12. What is the difference between chemical drugs and biopharmaceuticals in product/acitve agent sources?
    drugs are chemically synthesized or extracted from natural products and Biopharms are produced via biotechnology
  13. What is the difference between chemical drugs and biopharmaceuticals in identity?
    drugs are well defined and biopharmaceuticals are relatively poorly defined
  14. What is the difference between chemical drugs and biopharmaceuticals in structure??
    drugs are small and biopharms are big, complex,3D, folding
  15. What is the difference between chemical drugs and biopharmaceuticals in composition
    drugs are simple and single while biopharmaceuticals purity varies and are complex
  16. What is the difference between chemical drugs and biopharmaceuticals in Pharmacokinetics, pharmacodynamics/administration?
    • drugs = relatively simple
    • Biopharmaceuticals = more barriers, immune response
  17. What is the difference between chemical drugs and biopharmaceuticals in manufacturing?
    • Drugs = high consistency and purity
    • Biopharmaceuticals = Diverse, random, methods largely influence property, sterile condition, through test before use
  18. What is the difference between chemical drugs and biopharmaceuticals in storage?
    • Drug = shelf
    • Biopharmaceuticals = freezer stabilization materials, etc.
  19. What is the difference between chemical drugs and biopharmaceuticals in intellectual property?
    • Drugs = structure
    • Biopharmaceuticals = Biological entities, information, assays etc
  20. What is the difference between chemical drugs and biopharmaceuticals in regulation?
    • Drugs = relatively simple
    • Biopharms = lengthy and complex
  21. what are the major challenges facing biopharmaceuticals?
    • 1.stability
    • 2. barriers
    • 3. first pass metabolism
    • 4.ethical issues
    • 5.immunogenicity

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