Biopharmaceutical Analysis


This module encompasses a wide range of bioanalytical techniques and assays relevant to the analysis of biopharmaceuticals. The learner will gain practical experience in bioanalytical techniques performed on biopharmaceuticals from the initial upstream processing stages, harvest, downstream processing and the final QC testing of biopharmaceuticals.This module will also provide students with a detailed understanding of a range of specialised investigational techniques and their application areas and associated problems within the biopharmaceutical and related industries.The content delivered in this module is relevant to the skills in the biopharmaceutical sector and students on completion of this module will have a competency in the analysis of biopharmaceuticals.

Learning Outcomes

  1. Compare and contrast specialised techniques for potency, concentration and structural analysis of biopharmaceuticals 

  2. Assimilate the techniques for the analysis of protein purity such as SDS-PAGE, Isoelectric focusing, 2D electrophoresis and capillary electrophoresis.

  3. Evaluate and assess the applications and associated limitations of the bioanaytical techniques within the spectrum of biopharmaceutical manufacturing such as in raw material, intermediate product and end-product analysis.

  4. Perform HPLC, GC-MS, Ion Exchange HPLC,  XRF and AFM analysis in the laboratory and demonstrate how bioanalytical techniques both qualitative and quantitative methods, can be applied to the analysis and manipulation of different sample types.

  5. Assess the principles, applications and the instrumentation used for advanced aspects of modern analytical techniques such as high performance liquid chromatography (HPLC), gas chromatography, mass spectrometry, atomic force microscope and X-ray fluorescence analysis.

  6. Analyse, identify and interpret experimentally-derived data from the analysis of biological/pharmaceutical molecules. 

  7. Write scientific reports and interpret analytical data from the analysis of biological/pharmaceutical molecules.

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