| Topic |
Sub-topic |
| 1. BIOTECHNOLOGY IN THE PHARMACEUTICAL INDUSTRY |
Introduction. History of the pharmaceutical industry. Main biopharmaceuticals Current status of biotechnology and applications in the pharmaceutical industry. Impact of biotechnology and genomics in the drug development process. Pharmacoeconomics |
| 2. DEVELOPMENT OF NEW DRUGS IN THE POST-GENETIC ERA |
Compounds. Choice of pathology and biological target. Validation of a target Compounds and development of new drugs. Chemical in silico. Screening. Optimization of the compound. Other therapeutic strategies. |
| 3. BIOPHARMACEUTICAL TECHNOLOGIES AND PROCESSES IN THE DEVELOPMENT OF DRUGS |
Datamining, molecular cloning and characterization. Gene isolation. Protein expression systems. Molecular optimization to increase protein expression. Rational design examples: Sandostatin, Norvir, Enbrel. Drug development process. Clinical trials. |
| 4. BIOFACTOR SOURCES AND ANALYSIS OF THE FINAL PRODUCT |
Biopharmaceutical production systems. E.coli as a source of therapeutic recombinant proteins. Expression of recombinant proteins in animal cell culture systems. Additional production systems: Yeasts, fungi, transgenic animals, mosses and insects. Contaminants based on proteins. Elimination of altered forms of the protein of interest. Detection of protein-based impurities. Capillary electrophoresis. HPLC. Mass spectrometry. Immunological approaches for the detection of contaminants. Endotoxins and other pyrogenic contaminants. |
| 5. PHARMACOCINETICS AND PHARMACODYNAMICS OF BIOFARMACLES |
Introduction. Allometric scaling. Pharmacokinetic and pharmacodynamic particulates of peptides and proteins. Absorption and bioavailability. Elimination and metabolism. Glycosylation and protein stability. Proteolysis Preferential administration routes. |
| 6. VACCINES I |
Vaccines as specific immunoactivator drugs based on the processing of antigens. Identification of the type of vaccines by their origin and composition. Synthetic, recombinant, anti-idiotype vaccines. The immunology of adjuvants. Applications of vaccines: infectious diseases, autoimmune diseases and cancer. Perspectives in the development of new vaccines. |
| 7. VACCINES II |
From the genomic sequence to the discovery of vaccines. Vaccines versus Meningococcus-B. Approaches in silico, transcriptomics and proteomics. Identification of the antigenoma in pathogens. Reverse Vaccinology. |
| 8. MONOCLONAL ANTIBODIES AND IMMUNOTOXINES |
Define immunoglobulins and antisera as passive specific immunoactivator drugs. Distinguish immunoglobulin from antiserum. Place monoclonal antibodies, humanized monoclonal antibodies and immunotoxins in this context. Characterize pharmacologically these products. Identify the products of this type currently commercialized. |
| 9. SYNTHETIC PEPTIDES AND INFORMATION MEDICINES |
Characterize pharmacologically these products. Study the somatostatin analogues and gonadorelin as examples of peptoids. Synthetic DNA and RNA. Hybridons and/or antisense oligonucleotides. The triplex strategy with oligonucleotides. Interference RNAs: Mechanisms of action and therapeutic potential. |
| 10. RECOMBINANT PROTEINS APPLIED TO HUMAN THERAPEUTICS |
Insulin formulations, an example of pharmacotechnology. The non-natural insulins. Discuss the problems with recombinant proteins: Identify other products of this type currently on the market. The recombinant cytokines in human therapeutics. The case of interferons and their therapeutic applications. The false recombinant receptors. |
| 11. STEM CELLS AND SOMATIC GENE THERAPY AS BIOTECHNOLOGICAL PRODUCTS |
Clinical relevance. Stem cells as drugs. Therapeutic applications Artificial skin Somatic gene therapy. Tumor, cardiovascular and anti-infective gene therapy. |
| 12. NEW ANTIMICROBIANS |
Introduction. Methods for obtaining beta-lactams (penicillines, cephalosporins, monolactams, betalactamases inhibitors). Aminoglycosides (streptomycin, neomycin, gentamicin, kanamycin). Tetracycles. Macrolides Lincomicin. Peptide antibiotics. Other antibiotics. Recombinant techniques applied to the production of antibiotics. Hybrid antibiotics. |
| 13. APPLICATIONS OF GENOMICS, TRANSCRIPTMICS AND PROTEEMICS IN PHARMACEUTICAL BIOTECHNOLOGY |
Identification and validation of new therapeutic targets. Gene detection methods for Drug-resistant Genome and Proteome diseases. DNA microarrays and protein matrices. SNP and pharmacogenomics. |
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