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BIOT7011 - Pharma Analytics

Title:Pharma Analytics
Long Title:Pharma Analytics
Module Code:BIOT7011
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Biotechnology
Valid From: Semester 1 - 2017/18 ( September 2017 )
Module Delivered in 2 programme(s)
Module Coordinator: Brigid Lucey
Module Author: Rosemary Rea
Module Description: This module is designed to familarise students with the analytical testing requirements for raw materials, pharmaceuticals, biopharmaceutical protein products and water.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Outline the analytical tests required for drug substance, drug product, raw materials and water.
LO2 Describe the role of chromatography in purification, in-process and release testing of pharmaceuticals and biopharmaceuticals.
LO3 Discuss the principles and aim of process analytical technology.
LO4 Perform and report on experimental tasks related to pharma analytics.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

No requirements listed

Module Content & Assessment

Indicative Content
Analytical Testing Requirements for Protein Biopharmaceuticals
A description of the tests required for drug substance, drug product, raw materials and water i.e. identity, purity and impurities, potency, quantity and stability. Test methods (including but not limited to) - Bioassay, PAGE, HPLC, Mass Spec, QPCR, ELISA, IEF, MicroSeq
Principles of chromatography and instrumentation required. Role of chromatography in purification and analytical characterisation of biopharmaceuticals proteins.
Process Analytical Technology (PAT)
Principles of PAT - In line, on line, at line measurements. Methods for measuring critical quality attributes and critical process parameters e.g. NIRS, Raman, Biosensors.
Laboratory Program
Understand and/or perform experimental tasks related to pharma analytics.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions Short answer theory assessment 1,2,3 35.0 Week 8
Presentation Group presentations on topics relevant to lecture material commencing week 9 1,2,3 35.0 Sem End
Practical/Skills Evaluation Laboratory practicals and report writing 4 30.0 Every Second Week
No End of Module Formal Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.0 Every Week 2.00
Lab Laboratory Practicals 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Slef-Directed Study 4.0 Every Week 4.00
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • Syed Imtiaz Haider and Syed Erfan Asif 2011, Quality Control Training Manual, CRC Press [ISBN: 9871439849941]
Supplementary Book Resources
  • Katherine A. Bakeev 2010, Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, Wiley [ISBN: 9780470722077]
Supplementary Article/Paper Resources
  • A. S. Rathore, R. Bhambure and V. Ghare 2010, Process Analytical Technology (PAT) for Biopharmaceutical Prodcuts., Analytical Bioanalytical Chemistry, 398, 13715
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
CR_SPHBI_8 Bachelor of Science (Honours) in Pharmaceutical Biotechnology 5 Mandatory
CR_SBIBI_7 Bachelor of Science in Applied Biosciences and Biotechnology 5 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie