Type A
|
Code |
Competences Specific | | A6 |
Know how to design and apply experimental laboratory protocols in the fields of biotechnology, especially chemical, biochemical, microbiological and molecular biology, assessing their risks and safety elements. |
Type B
|
Code |
Competences Transversal |
Type C
|
Code |
Competences Nuclear |
Type A
|
Code |
Learning outcomes |
| A6 |
Describe the main methodologies of applications and processes used in the biopharmaceutical industry.
|
Type B
|
Code |
Learning outcomes |
Type C
|
Code |
Learning outcomes |
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. |
Methodologies :: Tests |
|
Competences |
(*) Class hours
|
Hours outside the classroom
|
(**) Total hours |
Introductory activities |
|
1 |
0 |
1 |
Lecture |
|
24 |
28 |
52 |
Seminars |
|
6 |
9 |
15 |
Personal attention |
|
1 |
0 |
1 |
|
Extended-answer tests |
|
2 |
2 |
4 |
Oral tests |
|
1 |
1 |
2 |
|
(*) On e-learning, hours of virtual attendance of the teacher. (**) The information in the planning table is for guidance only and does not take into account the heterogeneity of the students. |
Methodologies
|
Description |
Introductory activities |
Presentació de la matèria. |
Lecture |
Exposició dels continguts de la matèria |
Seminars |
Treball en profunditat d'un temari (monogràfic). |
Personal attention |
Resolució individual de dubtes. |
Description |
Meetings in the office: 106, with previous appointment by email: miquel.mulero@urv.cat
|
Methodologies |
Competences
|
Description |
Weight |
|
|
|
|
Extended-answer tests |
|
Various tests of development. |
90% |
Oral tests |
|
Exam that will be carried out during the development of the seminar by the student. The content and format of it will be evaluated, as well as the knowledge and defense capacity linked to the seminar carried out by the student. |
10% |
Others |
|
|
|
|
Other comments and second exam session |
In the 2nd call it will be evaluated all the contents of the subject. The seminar grade will be saved for this call. During the evaluation tests, mobile phones, tablets and other devices that are not expressly authorized for the test, must be turned off and out of sight. The demonstration of fraudulent conduct of some evaluative activity of some subject in both material and virtual and electronic support leads to the student the suspension note of this evaluation activity. Regardless of this, in view of the seriousness of the facts, the center may propose the initiation of a disciplinary file, which will be initiated by resolution of the rector. |
Basic |
J.M Walker, Molecular Biology and Biotechnology, tercera, Royal Society of Chemistry, (1993)
O.Kayser, Pharmaceutical Biotechnology. Drug Discovery and Clinical Applications, segona, Willey (2003)
G. Walsh, Biopharmaceuticals: Biochemistry and Biotechnology, tercera , Willey (1998)
G.Grandi, Genomics, proteomics and vaccines, primera, Willey (2004)
S.C.Gad, Handbook of Pharmaceutical Biotechnology, primera, Willey (2007)
M.Gibaldi, Biotchnology and Biopharmaceuticals. Transforming proteins and genes into drugs, segona , Willey (2003)
Texas University, Virtual laboratory of Pharmaceutical Biotechnology, , 2005
|
|
Complementary |
|
|
Subjects that it is recommended to have taken before |
|
(*)The teaching guide is the document in which the URV publishes the information about all its courses. It is a public document and cannot be modified. Only in exceptional cases can it be revised by the competent agent or duly revised so that it is in line with current legislation. |
|