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Analysis of biopharmaceuticals - GDEFA13

Title:	Analysis of biopharmaceuticals
Guaranteed by:	Department of Analytical Chemistry (16-16140)
Faculty:	Faculty of Pharmacy in Hradec Králové
Actual:	from 2019
Semester:	both
Points:	0
E-Credits:	0
Examination process:	oral
Hours per week, examination:	0/0, Ex [HT]
Capacity:	winter:unknown / unknown (unknown) summer:unknown / unknown (unknown)
Min. number of students:	unlimited
4EU+:	no
Virtual mobility / capacity:	no
Key competences:
State of the course:	taught
Language:	English
Teaching methods:	full-time
Teaching methods:	full-time
Level:
Note:	course is intended for doctoral students only enabled for web enrollment you can enroll for the course in winter and in summer semester

Guarantor:	prof. PharmDr. Lucie Nováková, Ph.D.

Examination dates WS schedule SS schedule

Annotation -

Last update: prof. PharmDr. Lucie Nováková, Ph.D. (30.09.2021)

Students will get knowledge concerning the basic and advanced analytical methods of bio-analysis with a focus on quality control of biopharmaceuticals of a protein nature. Particular emphasis will be given to liquid chromatography and mass spectrometry methods, which are suitable for the analysis of therapeutic monoclonal antibodies and conjugates of monoclonal antibodies with low molecular weight, pharmacologically active substances.

Requirements to the exam -

Last update: prof. PharmDr. Lucie Nováková, Ph.D. (30.09.2021)

The following knowledge will be required to pass the exam:

Definition of bio-pharmaceuticals, specifics of bio-pharmaceuticals compared to standard synthetic pharmaceuticals, biological treatment properties, overview of bio-medicinal products in the past and present market
Types of biological drugs (monoclonal antibodies, monoclonal antibody conjugates, fusion proteins, bispecific antibodies)
Basic structure of biological drugs (primary, secondary, tertiary, quaternary), post-translational and arteficial modifications
General structure of monoclonal antibodies and their distribution by production organisms, structure of monoclonal antibody conjugates, structure of Fc-fusion proteins, structure of bispecific antibodies
Basic principles of biofuel production
Biosimilars - Generic Biologicals
Biological analyzes, critical attributes of quality
Analysis of amino acid representation - material preparation and appropriate analytical methods
Peptide mapping - material preparation and appropriate analytical methods
Analysis of post-translational and arteficial modifications - examples of important modifications, preparation of material, suitable analytical methods, analysis of glycans
Analysis of Intact Proteins - Specifics of Intact Protein Analysis and Appropriate Analytical Methods