IDENTIFYING DATA 2018_19
Subject (*) VACCINES AND PHARMACEUTICAL DRUGS Code 19204206
Study programme
Bachelor's Degree in Biotechnology (2009)
 Cycle 1st
Descriptors Credits Type Year Period
3 Optional 1Q
Language
Català
Department Biochemistry and Biotechnology
Coordinator
MULERO ABELLÁN, MIGUEL
 E-mail miquel.mulero@urv.cat
Lecturers
MULERO ABELLÁN, MIGUEL
Web
General description and relevant information The course aims to provide biotechnology students with basic language and knowledge in pharmacology and immunology to understand how certain types of biotechnological products are transformed into medicines, with the vaccine being an emblematic example of the process. The language learned should allow to communicate with professionals in the pharmaceutical industry, that is to say, scientific researchers, pharmacists, clinical pharmacologists or specialists in pharmaceutical marketing. The knowledge and detailed analysis of the biotechnological products present in the market will provide the basis to evaluate the current situation and perspectives of biotechnological products as human therapeutic agents. In conclusion, the objectives of this subject is that the student reaches basic notions that prepare him for a possible incorporation to the pharmaceutical industry. As a result of the extinction of the study plan that is being studied, this subject is done through tutoring (except in the studies of the ETSE). For more information, you should consult the teacher's personalized attention schedule.

Competences
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
 B6 Clear and effective communication of information, ideas, problems and solutions in public or a specific technical field
Type C Code Competences Nuclear

Learning outcomes
Type A Code Learning outcomes
 A6 Describe the main methodologies of applications and processes used in the biopharmaceutical industry.
Type B Code Learning outcomes
 B6 Analyze and publicly develop the state of the art of an application/technique in the field of biopharmaceutical industry.
Type C Code Learning outcomes

Contents
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.

Planning
Methodologies  ::  Tests
  Competences (*) Class hours
 Hours outside the classroom
 (**) Total hours
Introductory activities
1 0 1
Lecture
A6
 24 28 52
Seminars
B6
 6 9 15
Personal attention
1 0 1
 
Extended-answer tests
A6
 2 2 4
Oral tests
B6
 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
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.

Personalized attention
Description
Meetings in the office: 106, with previous appointment by email: miquel.mulero@urv.cat

Assessment
Methodologies Competences Description Weight        
Extended-answer tests
A6
 Various tests of development. 90%
Oral tests
B6
 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.

Sources of information

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

Recommendations


Subjects that it is recommended to have taken before
IMMUNOLOGY/19204109
(*)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.