SFKKB9071U Immunological and Microbiological Methods in Quality Control of Medicines

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, Cand.Pharm. - elective
Content
The course offers a wide spectrum of microbiological and immunological methods of drug control based on the use of antibodies, cell cultures and intact research animals. The course will place special emphasis on analytical problems associated with the determination of substances at picogram levels in biological material and drugs.
The course covers the following topics:
  • Endotoxin determination (Limulus and rabbit pyrogen test according toPh. Eur.)
  • Immunoassay (Dissociation-Enhanced Lanthanide Fluorescence Immunoassay) to determine cytokines
  • A rapid method for determining gentamycin by bioluminescence
  • Bioluminescence as a rapid methodfor determining viable bacteria (alternative method described in Ph. Eur.)
  • Using human cell cultures (monocyte and granulocyte cell lines) to determine immunomodulatory effectand pyrogens
  • Monocyte activation test (MAT according to Ph. Eur.)
  • How cell lines can be used as bioassays Oxidative burst activity of granulocytes – a rapid method for determining microbial substances
  • Test for sterility
  • Quality control of biologics
Learning Outcome

Formål / Objective

To give students the opportunity to learn, evaluate and execute microbiological and immunological methods in research and quality control of medicines. The methods described in Ph.Eur. and other regulatory authorities are addressed.

Målbeskrivelse / Course outcome

General abilities: The students will acquire practical and theoretical abilities and skills in microbiological and immunological methods used for research and quality control of medicines. The methods are applicable in the pharmaceutical industry and in academia.

Specific abilities:By the end of the course, the students will have acquired the ability to:
  • design in vitro assays for evaluation of immumodulation, including choosing the proper model system and assay conditions
  • design an experiment on the basis of original literature to illustrate immunomodulation
  • analyse and evaluate the results of different in vitro techniques
  • identify analytical problems in cell based assays
  • calculate and interpret data (dose-response relationships)
  • use a graphics program (SigmaPlot) to show results graphically
  • evaluate scientific literature within the topics covered by the course, as well as to search scientific literature in databases (Medline and others)
  • conduct Quality Control as described by Regulatory Authorities
  • conduct experiments using in vitro techniques like cell lines, immunoassays and enzymatic assays
  • detect and measure endotoxin and other pyrogens in pharmaceutical formulations.
Specific practical skills:By the end of the course, the students will have acquired sufficient skills to be able to:
  • work with cell lines (monocytes and granulocytes) under aseptic conditions
  • measure cytokines in cell cultures using immunoassays (ELISA/DELFIA technique)
  • perform Limulus (LAL) test and validation of LAL test
  • perform Monocyte activation test (MAT) and validation of MAT
  • solve issues of interference in enzymatic and cellular assays
  • measure ATP in samples
  • measure reactive oxygen species in cell cultures
  • perform ultrafiltration
  • execute total viable count
Literature
Scientific articles and instructions for laboratory exercises
Course teaching is based on the assumption that students have knowledge and experimental competences in biochemistry, microbiology and pharmacology at Bachelor’s level.
• Class lessons: 2 hours
• Seminars: 12 hours
• Laboratory exercises: 60 hours
  • Category
  • Hours
  • Colloquia
  • 14
  • Practical exercises
  • 60
  • Preparation
  • 50
  • Project work
  • 82
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Oral examination under invigilation
Prøveform / Examination type:
Oral examination

Prøvedesign / Examination design
Oral examination: 15 minutes, plus 30 minutes of preparation time. The exam covers laboratory work ( (instructions for laboratory exercises and report) as well as the scientific articles presented at the seminars.

Særlige forhold / Special conditions:
To be eligible to take the exam, students must have participated in the seminars plus have submitted reports.
Aid
Only certain aids allowed
  • Permitted aids for exam preparation: All written and approved pocket calculator
  • Permitted aids at the actual exam: Own notes from exam preparation
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment

Beskrivelse af prøven og bedømmelse / Description of examination and assessment criteria

Karakterbeskrivelse / Description of grades

12 - Excellent performance
A well-structured response formulated clearly and precisely. The student demonstrates a high-level command of the material and has in-depth scientific insight when incorporating relevant scientific elements in response to the given questions.
The student demonstrates in general with few minor weaknesses:
  • Convincing command of the pharmaceutical microbiological-immunological literature in relation to the questions asked
  • Convincing ability to use the concepts, methods and correlations of pharmaceutical microbiology and immunology in relation to the questions asked
  • Based on experimental and scientific data, the ability to clearly and precisely calculate, analyse and evaluate parameters that make up pharmaceutical, microbiological and immunological issues
  • Ability to evaluate procedures and methods to ensure microbiologically safe drugs.
7 - Good performance
A coherent response formulated reasonably clearly and precisely. The student demonstrates a reasonable command of the material and has scientific insight when incorporating relevant scientific elements in response to the given questions.
The student demonstrates in general with some weaknesses:
  • Reasonable command of the pharmaceutical microbiological-immunological literature in relation to the questions asked
  • Reasonable ability to use the most important concepts, methods and correlations of pharmaceutical microbiology and immunology in relation to the questions asked
  • Based on experimental and scientific data, reasonable ability to somewhat clearly and precisely calculate, analyse and evaluate parameters that make up pharmaceutical, microbiological and immunological issues
  • Ability to give an account of the procedures and methods to ensure microbiologically safe drugs.
02 - Acceptable performance
A somewhat coherent response that is rather unclear and imprecise in formulation. The student demonstrates limited command of the material and is only to a certain extent able to incorporate relevant scientific elements in response to the given questions.
The student demonstrates in general with several significant weaknesses:
  • Acceptable command of the pharmaceutical microbiological-immunological literature in relation to the questions asked
  • Acceptable ability to use the most important concepts, methods and correlations of pharmaceutical microbiology and immunology in relation to the questions asked
  • Based on experimental and scientific data, acceptable ability to somewhat clearly and precisely calculate, analyse and evaluate parameters that make up pharmaceutical, microbiological and immunological issues
  • Acceptable ability to give an account of the procedures and methods to ensure microbiologically safe drugs.