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    Biopharmaceuticals Biopharmaceuticals Presentation Transcript

    • Development of Biopharmaceuticals
    • What are Biopharmaceuticals
      • Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology methods, with the products having biological sources, usually involving live organisms or their active components
      • Biopharmaceuticals are protein or nucleic acid based pharmaceuticals (substance used for therapeutic or in vivo diagnostic purpose), which are produced by mean other than direct extraction from a native biological source.
    • Pharmaceutical Technology
      • The methods and techniques that involve the use of living organisms (such as cells, bacteria, yeast and others) are tools to perform specific industrial or manufacturing process are called biotechnology
      • Pharmaceutical Technology will continue to provide new breakthroughs in medical research in the years to come, leading to treatment in field which have previously eluded us (including AIDS, cancer asthma, Parkinson’s disease, Alzheimer disease)
    • Pharmaceutical Biotechnology
      • Biotechnology offers better product-targeting for specific diseases and patient groups, through the use of innovative technologies, in particular, genetics. Examples include, amongst others, treatment for rare diseases and cancers.
      • Some products are not naturally created in sufficient quantities for therapeutics purpose.
      • Biotechnology makes large-scale production of existing substances possible, for example, insulin in the field of diabetes treatment
    • Biopharmaceuticals history
    • Protein Therapeutics
      • Proteins/peptides are gaining prominence
      • Proteins - ideal drugs as they carry out essentially all biologic processes and reactions
      • Recombinant DNA, hybridoma techniques, scale fermentation and purification processes brought new series of Proteins/peptides
    • Protein Pharmaceuticals
      • Insulin (diabetes)
      • Interferon  (relapsing MS)
      • Interferon  (granulomatous)
      • TPA (heart attack)
    • Protein Pharmaceuticals
      • Actimmune (If g)
      • Activase (TPA)
      • BeneFix (F IX)
      • Betaseron (If b)
      • Humulin
      • Novolin
      • Pegademase (AD)
      • Epogen
      • Regranex (PDGF)
      • Novoseven (F VIIa)
      • Intron-A
      • Neupogen
      • Pulmozyme
      • Infergen
    • Challenges with Proteins
      • Very large and unstable molecules
      • Structure is held together by weak non-covalent forces
      • Easily destroyed by relatively mild storage conditions
      • Easily destroyed/eliminated by the body
      • Hard to obtain in large quantities
    • Problem with Proteins (in vivo – in the body)
      • Elimination by B and T cells
      • Proteolysis by endo/exo peptidases
      • Small proteins (< 30 kD) filtered out by the kidneys very quickly
      • Unwanted allergic reactions may develop (even toxicity)
      • Loss due to insolubility/adsorption
    • How to Deal with These Problems Storage Delivery Formulation
    • How to Deal with These Problems Storage Delivery Formulation
    • Storage (additives)
      • Addition of stabilizing salts or ions (Zn + for insulin)
      • Addition of polyols (glycerol and/or polyethylene glycol) to solubilize
      • Addition of sugars or dextran to displace water or reduce microbe growth
      • Use of surfactants (CHAPS) to reduce adsorption and aggregation
    • Protein Formulation
      • Protein sequence modification (site directed mutagenisis)
      • PEGylation
      • Proteinylation
      • Peptide Micelles
      • Formulating with permeabilizers
    • Formulation with permeabilizers
      • Salicylates (aspirin)
      • Fatty acids
      • Metal chelators (EDTA)
      • Anything that is known to “punch holes” into the intestine or lumen
    • Drug Delivery
      • Non-conventional way of administering drugs (novel drug delivery)
      • Conventional way
              • Oral (Tablets, Capsules)
              • Parenteral (IV injections)
    • Role of a Pharmaceutical Engineer
      • Modeling of drug delivery systems
          • Prediction of kinetics/thermodynamics
      • Novel polymer research
          • Temperature sensitive polymers; pH sensitive polymers
      • Development of new drug delivery techniques
          • Novel techniques for new therapies
      • Development of purification processes
          • Solvent Removal; Removal of impurities etc.
      • Process development
          • Design & Development of robust processes; GMP Validation
      • Scale-up of processes