Veidlapa Nr. M-3 (8)
Study Course Description
Biological Drugs
Course Code
LFK_051
Branch of Science
Basic medicine
ECTS
2.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Renāte Ranka
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 21 Consula Street, farmkk@rsu.lv, +371 67061544
About Study Course
Objective
This course has been designed to introduce students to the basic biotechnology and various types of biopharmaceutical products, and to enable students to understand the design principles and quality assessment for biologic therapeutics.
Preliminary Knowledge
Biology, pharmacology.
Learning Outcomes
Knowledge
1.Knowledge about basics of biotechnology, different types of biotherapeutics and their therapeutic areas.
Skills
1.To evaluate the quality of biological medicines, to apply basic analysis methods.
Competences
1.To understand design principles for biologics and the biologics drug life-cycle.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Scientific literature review.
Completion of the study course evaluation questionnaire.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
10 points
|
|
Prepare a presentation on the selected topic. Completion of the study course assessment questionnaire. |
||
|
2.
Examination |
-
|
10 points
|
|
Interpretation of literature analysis data. |
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Introduction in biopharmaceutics.
|
|
Basis of biotechnology
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Quality assessment for biopharmaceutics
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Basis of biotechnology
|
|
Bioanalysis of biologics
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Gene analysis methods
|
|
Protein analysis methods
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Therapeutic proteins. Recombinant insulin.
|
|
Monoclonal antibodies
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Bioassays
|
|
Monoclonal antibodies
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Monoclonal antibodies
|
|
RNA therapeutics
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Residual DNA Testing
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
RNA therapeutics
|
|
Gene-based and cellular biologics
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Gene therapy
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biosimilars
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Presentation of the course work
|
Total ECTS (Creditpoints):
2.00
Contact hours:
24 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
Zinātnisko publikāciju datu bāzes./Databases of scientific publications.
Additional Reading
1.
FDA. Purple Book. Database of Licensed Biological Products