BIO07015 2019 Bioanalytial Techniques L7 Practical.
This module aims to provide students with a broad knowledge of the practice of the various pharmacopoeia test methods and associated laboratory instrumentation routinely employed in a Biopharmaceutical Quality Control laboratory to assess the quality of raw materials, intermediate and finished-goods product.
On completion of this module the learner will/should be able to;
Interpret the European Pharamcopoeia and US Pharmacopoeia for QC Testing.
Outline and evaluate the common test methods routinely employed in the analysis of pharmaceutical and biopharmaceutical products.
Describe the typical analytical equipment employed for performance of the analytical test methods.
Perform a range of analysis lab. experiments and outline and evaluate the equipment requirements for performance of the various test methods.
Demonstrate understanding of how to interpret data from both qualitative and quantitative analytical techniques using GLP as would be required in a QC laboratory.
Analyse and draw conclusions from typical data obtained in an analytical laboratory and/or data presented in problem solving exercises.
Teaching and Learning Strategies
Module Assessment Strategies
A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.
The following is a summary indication of the main topics included in this module:
Introduction to GLP, GMP and ISO 17025.
Conduct a series of laboratory-based experiments in the following area of QC analysis:
- pH calibration and measurements.
- Conductivity measurements.
- Melting point.
- Osmolality measurements.
- Loss on drying.
- Residue on Ignition.
- Heavy Metals tests.
- Optical rotation.
- Particle size analysis.
- Relative density.
- HPLC – Principles and Applications.
- Protein Electrophoresis.
- Immunoassays and protein assays.
- Introduction to PCR equipment.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Continuous Assessment Short-form exams and lab. experiments write-ups.||Continuous Assessment||Assessment||100 %||OnGoing||1,2,3,4,5,6|
Part Time Mode Workload
|Lecture||Distance Learning Suite||Online lecture.||1||Weekly||1.00|
|Laboratory Practical||Science Laboratory||Lab.-based experimetns.||16||Once Per Semester||1.07|
Protein Biochemistry and proteomics: Publisher: Elsevier ISBN: 978-0-12-088545-9.
Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.