Principles and Practice of Bioanalysis

Course content

One part of the course will cover the separation techniques GC, HPLC and CE and their coupling with spectroscopic detection principles such as UV-VIS, fluorescence and MS. Focus will be on separation mechanisms and selective detection in order to obtain reliable quantitative bioanalytical data.
Another part of the course will cover sample preparation techniques including liquid-liquid extraction, solid phase extraction and protein precipitation. The advantages and limitations of each technique will be discussed in order to enable the student to make the best choice of analytical method taking into account the nature and concentration of the analyte, the matrix and the accuracy, precision and time of analysis.

The course will cover the complete bioanalytical process starting with sampling, sample conditioning, sample treatment/preparation, instrumental analysis, derivatisation/structure modification, detection/identification, data handling, data interpretation/evaluation, decision-making and troubleshooting.


The most relevant course topics will be:

  • Sampling of biological materials (e.g. representative samples, homogeneity, stability, traceability)
  • Types of samples needed for different investigations
  • Physicochemical composition of biological matrices (e.g., drug-protein binding, matrix interferences, enzymatic effects)
  • Matrix effects during instrumental analysis (e.g., clogging/blocking effects, ion-suppression/enhancement effects, robustness /ruggedness)
  • Physicochemical properties of analytes and matrices with respect to chemical analysis (e.g., acid-base properties, solubility, polarity)
  • Sample handling (e.g. initial sample treatment, storage, stability)
  • Sample clean-up and preparation (off-line, at-line, on-line, in-line approaches to improve selectivity and or sensitivity or to perform a phase transfer. In addition to the traditional sample preparation techniques, new developments with respect to selective sorbents, miniaturized approaches and high-throughput robotic devices will be included);
  • Analytical separation methodologies, both traditional (e.g., LC, GC, CE, SFC) and advanced (e.g., UPLC, HPLC, assay-based techniques) separation techniques will be discussed)
  • Instrumental identification and detection approaches, both traditional (e.g., absorbance, fluorescence, diode array, IR, MS) and advanced (e.g., MS/MS, MSn, NMR, biochemical) detection/identification techniques will be discussed
  • Bio-pharmaceutical analysis (e.g., amino acids, peptides/proteins, nucleotides)
  • Industrial aspects (e.g., automation, robotics, high-throughput devices)
  • Forensic application will be demonstrated
  • Validation issues (e.g., bio-statistics, data-acquisition/evaluation, chemometrics)
  • Robustness/ruggedness testing (e.g. techniques and approaches to guarantee the quality of the developed methodologies), troubleshooting, matrix.
Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme)- elective 

MSc Programme in Environmental Science (SCIENCE) - restricted elective

Learning outcome

At the end of the course, students are expected to be able to:

Knowledge

  • know the capability and limitations of the individual analytical techniques with respect to selectivity and sensitivity.
  • discuss and present the results of a chemical analysis.

 

Skill

  • know and be able to use a broad number of separation and detection principles as well as sample preparation techniques used for bioanalysis.
  • understand the principles behind and use the analytical chemical instrumentation needed for high sensitivity analysis of samples of biological origin.
  • judge and use the relevant original analytical chemical literature, handbooks and databases.

 

Competence

  • understand and perform bioanalytical chemical work.
  • develop new analytical chemical methods for analysis of samples of biological origin (e.g. urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
  • design sampling and storage protocols for in vivo studies of drug substances.

Lectures: 32 hours
Laboratory exercises: 24 hours

  • Steen Honore Hansen, Stig Pedersen-Bjergaard: Bioanalysis of Pharmaceuticals: Sample Preparation, Chromatography and Mass Spectrometry, ISBN: 978-1-118-71682-3, Wiley (2015)
  • Harris, D.C. Quantitative Chemical Analysis (2011). Publisher: W H Freeman 8 th ed.
  • FDA guideline: Validation of Bioanalytical methods.
  • The European Pharmacopoeia: Chromatography
  • Additional course materials such as manuals and scientific papers are availabe from the course homepage

Course teaching is based upon the assumption that the student has acquired basic skills in instrumental analytical chemistry corresponding to at least a 7.5 ECTS course at bachelor level. In addition general knowledge within the areas of organic chemistry, inorganic chemistry, physical chemistry, analytical chemistry, biochemistry, pharmacology, toxicology and drug development at bachelors level is expected.

ECTS
7,5 ECTS
Type of assessment
Written examination, 2 timer under invigilation
Examination type:
2 hour multiple-choice test.

Examination design:
The multiple choice-test is made up of a number of statements (typically 50) to which the student has to decide whether they are true or false.
Aid
Written aids allowed

There is access to the following at the exam on Peter Bangs Vej:

  • Office (Word, Excel, Onenote and Powerpoint)
  • IO2 – the digital pen
  • Panoramic Viewer
  • Paint
  • Calculator – Windows' own
  • R – Statistical programme
  • ITX MC – multiple choice programme
  • Adobe reader
  • ChemDraw
  • USB access – for usb stick with notes etc.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To pass the course the student must be able to:

Knowledge

  • know the capability and limitations of the individual analytical techniques with respect to selectivity and sensitivity.
  • discuss and present the results of a chemical analysis.

 

Skill

  • know and be able to use a broad number of separation and detection principles as well as sample preparation techniques used for bioanalysis.
  • understand the principles behind and use the analytical chemical instrumentation needed for high sensitivity analysis of samples of biological origin.
  • judge and use the relevant original analytical chemical literature, handbooks and databases.

 

Competence

  • understand and perform bioanalytical chemical work.
  • develop new analytical chemical methods for analysis of samples of biological origin (e.g. urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
  • design sampling and storage protocols for in vivo studies of drug substances.

 

Students are evaluated from the participation in the laboratory exercises as well as from the multiple choice examination and their "Independent Study Activity" where they critically present analytical chemical literature.

Single subject courses (day)

  • Category
  • Hours
  • Lectures
  • 32
  • Preparation
  • 150
  • Practical exercises
  • 24
  • English
  • 206