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Biopharmaceutical
A pharmaceutical inherently biological in nature and manufactured using biotechnology
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drug
a pharmaceutical inherently chemical (not biological) in nature and manufactured using chemical methods
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Pharmaceutical
a medicinal product (both active agents and formulated products) including therapeutics prophylactics and in vivo diagnostics, two major subsets are drugs and biopharmaceuticals
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3 main examples of biopharmaceuticals
proteins (including antibodies), Nucleic acids, Living microorganisms (including cells, virus, bacteria, even tissues)
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What was the major breakthrough in 1970?
restriction enzymes that cut DNA at specific sites
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The joining of two DNA fragments by DNA ligase and produces a DNA molecule
Recombinant DNA technology
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Polymerase chain reaction (PCR)
way to multiply DNA quickly and efficiently
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What was the first FDA approved biopharmaceutical?
recombinant human insulin
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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
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what does ADME stand for?
absorption, distribution metabolism and excretion
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how many phases are there in a clinical trial?
4 phases
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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
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What is the difference between chemical drugs and biopharmaceuticals in identity?
drugs are well defined and biopharmaceuticals are relatively poorly defined
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What is the difference between chemical drugs and biopharmaceuticals in structure??
drugs are small and biopharms are big, complex,3D, folding
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What is the difference between chemical drugs and biopharmaceuticals in composition
drugs are simple and single while biopharmaceuticals purity varies and are complex
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What is the difference between chemical drugs and biopharmaceuticals in Pharmacokinetics, pharmacodynamics/administration?
- drugs = relatively simple
- Biopharmaceuticals = more barriers, immune response
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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
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What is the difference between chemical drugs and biopharmaceuticals in storage?
- Drug = shelf
- Biopharmaceuticals = freezer stabilization materials, etc.
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What is the difference between chemical drugs and biopharmaceuticals in intellectual property?
- Drugs = structure
- Biopharmaceuticals = Biological entities, information, assays etc
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What is the difference between chemical drugs and biopharmaceuticals in regulation?
- Drugs = relatively simple
- Biopharms = lengthy and complex
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what are the major challenges facing biopharmaceuticals?
- 1.stability
- 2. barriers
- 3. first pass metabolism
- 4.ethical issues
- 5.immunogenicity
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