RESEARCH AND DEVELOPMENT OF BIOLOGICAL AND SMALL MOLECULE DRUGS AND OMIC ASPECTS OF RATIONAL DRUG DESIGNModule RESEARCH AND DEVELOPMENT OF BIOLOGICAL AND SMALL MOLECULE DRUGS
Academic Year 2022/2023 - Teacher: Salvatore GUCCIONEExpected Learning Outcomes
Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition.
After finalizing this course, the student will be able to
- compare biological with small molecule-drugs and understand how they differ in terms of discovery and development; understand the singularities of peptide drugs as a “transition” case in between both extremes;
- describe the key features of pharmaceutical biotechnology and biopharmaceuticals;
- describe and classify the most important biopharmaceuticals according to their production methods, characteristics and indications;
- compare the biotechnological production of drugs using plants, microbes and animal cells;
- characterize the production of recombinant proteins, antibodies and blood-derived products;
- understand the basic theoretical principles of advanced therapies (gene and cell therapies) and their practical challenges;
- get familiarized with the most important current regulatory aspects of biological drugs,
- get in-deep knowledge of one model biological drug, via completion of the case-studies.
Course Structure
Frontal Lessons. Attendance of lessons is recommended.
Perequisites: Organic Chemistry and General Biochemistry.
According to "Regolamento Didattico di Ateneo (R.D.A.) i.e. University Didactic Regulations attendance of lessons is mandatory.
Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.
Learning assessment may also be carried out on line, should the conditions require it.
Information for students with disabilities and / or SLD: To guarantee equal opportunities and in compliance with the laws in force, interested students can ask for a personal interview in order to plan any compensatory and / or dispensatory measures, based on the teaching objectives and specifications needs. It is also possible to contact the CInAP contact person (Center for Active and Participatory Integration - Services for Disabilities and / or SLD) of the Department of Biomedical and Biotechonological Sciences.
Required Prerequisites
Detailed Course Content
Course will consist of lectures, content of which will include classification of biological drugs, their production and their therapeutic use. Experimental biological drugs of particular interest will also be discussed .
Text-book Pharmaceutical Biotechnology: Concepts and Applications by Gary Walsh downloadable from :
http://site.iugaza.edu.ps/tbashiti/files/2013/02/2.Pharmaceutical_Biotechnology_ConceptsApplications-Gary_Walsh.pdf
Chapter 1,4,5, 11(subpar. 1 and 2),13,14.
Other chapters in the text-book can be used at the student' s best convenience as "ad hoc" background or as useful readings to master the course.
Textbook Information
1) Pharmaceutical Biotechnology: Concepts and Applications by Gary Walsh, WILEY, ISBN: 978-0-470-01244-4 downloadable from http://site.iugaza.edu.ps/tbashiti/files/2013/02/2.Pharmaceutical_Biotechnology_ConceptsApplications-Gary_Walsh.pdf
2) Biological Drug Products: Development and Strategies, Wei Wang (Editor), Manmohan Singh (Editor), WILEY, ISBN: 978-1-118-14889-1 November 2013.
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Chapters 1,4,5, 11 (subpar. 1 and 2), 13,14. Other chapters of the textbook can be freely used by the student for "ad hoc" basic knowledge or as useful readings for any further study. | 1) Pharmaceutical Biotechnology: Concepts and Applications by Gary Walsh, WILEY, ISBN: 978-0-470-01244-4 scaricabile da http://site.iugaza.edu.ps/tbashiti/files/2013/02/2.Pharmaceutical_Biotechnology_ConceptsApplications-Gary_Walsh.pdf . 2)Biological D |
Learning Assessment
Learning Assessment Procedures
Learning assessment may also be carried out on line, should the conditions require it.
Information for students with disabilities and / or SLD:
To guarantee equal opportunities and in compliance with the laws in force, interested students can ask the staff for an interview in order to plan any compensatory and / or dispensatory measures, based on educational objectives and specific needs.
It is also possible to contact the referent teacher CInAP (Center for Active and Participated Integration - Services for Disabilities and / or SLD) of the Drug and Health Sciences Department, Prof. Maria Stella Carmela Valle".