Veidlapa Nr. M-3 (8)
Study Course Description
Biological Drugs
Course Code
LFK_051
Branch of Science
Basic medicine; Other basic medicines; Technology of Drug Forms
ECTS
2.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Baiba Mauriņa
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 21 Consula Street, lfk@rsu.lv, +371 67061547
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 |
-
|
-
|
|
Active participation in seminars |
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
50.00% from total grade
|
10 points
|
|
Test in the study environment |
||
|
2.
Examination |
50.00% from total grade
|
10 points
|
|
Test in the study environment |
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
A review of the development of pharmaceutical biotechnology. Principles and perspectives of the development of biopharmaceutical medicinal preparations. Trends in the development of the pharmaceutical biotechnology industry and biopharmaceuticals.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
From DNA to therapeutic protein. Genomic DNA and cDNA libraries. DNA sequencing and polymerase chain reaction. Principles of recombinant DNA technology. Methods of introducing the DNA-vector construct into cells. Selection of transformed cells.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Upstream and downstream processes in manufacturing of therapeutic proteins. Principles of cultivation of cell culture for the production of recombinant proteins. Methods of protein extraction and purification.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Analytical characterization of therapeutic proteins.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Therapeutic monoclonal antibodies – challenges in drug development
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biosimilars and their special characteristics
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Formulations and novel solutions for delivery of biologicals
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Stabilization of biopharmaceutical products in liquid and in solid formulations
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Stabilization of biopharmaceutical products in liquid and in solid formulations
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Exercises in groups. Discussion on technology development for manufacturing of therapeutic proteins
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Exercises in groups. Discussion on quality aspects of therapeutic proteins.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Formulations and novel solutions for delivery of biologicals
|
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