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Protein Therapeutics: a summary and pharmacological classification

Explore the vast potential and pharmacological classification of protein therapeutics, covering benefits, challenges, regulatory aspects, and functional categories in the field. Learn about the advantages, significant proteins, and disease views associated with this cutting-edge medical approach. Uncover the diverse applications, including diagnostic tools, vaccines, and enzyme replacements. Stay informed on the latest advancements and developments in protein therapeutics for enhanced understanding and clinical implementation. |

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Protein Therapeutics: a summary and pharmacological classification

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  1. Protein Therapeutics: a summary and pharmacological classification Benjamin Leader, Quentin J. Baca and David E. Golan Yiben Wang 11/16/11

  2. Protein Therapeutics: -25,000-40,000 different genes in the human genome -Alternative splicing of genes -Post-translational modifications -Very high number of functionally distinct proteins Disease View: -Immense challenge: -One protein is mutated or abnormal -Present in high or low concentrations Therapeutic View: -Tremendous opportunity 130 different proteins or peptides – FDA approval

  3. Advantages of protein therapeutics: • Proteins – highly specific and complex set of functions • -Chemical compounds can’t mimick • Specificity • -Less chance of interference; reduce adverse effects • Natural production • -Well tolerated; no immune response • Diseases – gene is deleted or mutated • -Replacement treatment – no gene therapy (Unavailable) • Faster FDA approval time • -2003: 1980-2002  33 therapeutic proteins, 294 small-molecule drugs (>1year) • Unique form and function • -Companies – patent protection

  4. Functional classification of protein therapeutics: Group I -Protein therapeutics with enzymatic or regulatory activity Group II -Protein therapeutics with special targeting activity Group III -Protein vaccines Group IV -Protein diagnostics

  5. Group I: Protein therapeutics with enzymatic or regulatory activity Ia: Replacing a protein that is deficient or abnormal Ib: Augmenting an existing pathway Ic: Providing a novel function or activity

  6. Group II: Protein therapeutics with special targeting IIa: Interfering with a molecule or organism IIb: Delivering other compounds or proteins

  7. Group III: Protein vaccines IIIa: Protecting against a deleterious foreign agent IIIb: Treating an autoimmune disease IIIc: Treating cancer

  8. Group IV: Protein diagnostics

  9. Challenges for protein therapeutics: • Protein solubility, route of administration, distribution, and stability. • Immune response. • Physiologically active – post-translational modifications. • Costs • 5. Ethics

  10. Recombinant human proteins: -FDA – biotechnology medicines: -Monoclonal antibodies -Natural interferons -Vaccines -Hormones -Modified natural enzymes -Cell therapies More work needs to be done.

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