PHAR S8008 - Biopharmaceutical Processing (Downstream)

Module Details

Module Code: PHAR S8008
Full Title: Biopharmaceutical Processing (Downstream)
Valid From:: Semester 1 - 2019/20 ( June 2019 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 7.5
Module Owner:: annamarie rogers
Departments: Unknown
Module Description: The aim of this module is to provide students with an in-depth knowledge of the downstream processing of biopharmaceuticals (both theoretical and practical topics) pertaining to the isolation and purification of biopharmaceuticals.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Evaluate primary cell separation techniques including flocculation, depth filtration, tangential flow filtration and centrifugation.
MLO2 Evaluate chromatographic separations for capture of biopharmaceutical proteins.
MLO3 Compare and contrast filtration systems with chromatographic processes for final polishing of biopharmaceuticals.
MLO4 Characterise finished biopharmaceutical products.
MLO5 Apply practical competence in selected chromatography and filtration techniques.
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 DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Primary Cell Separation
Intracellular biopharmaceutical recovery- cell disruption (mechanical and chemical), flocculation, centrifugation (disk stack centrifuge, decanter centrifuge), filtration ( normal flow filtration (NFF), tangential flow filtration (TFF), single path TFF, alternate flow TFF). Extracellular biopharmaceutical product recovery - centrifugation or filtration (NFF, TFF). Intracellular biopharmaceutical recovery- cell disruption, centrifugation, filtration.
Chromatographic capture of biopharmaceuticals
Selection of a capture process - Protein A affinity chromatography, Ion exchange chromatography
Filtration systems for viral inactivation & final polishing
Selection of filtration system. Comparative evaluation of NF versus TFF. Concentration and diafiltration of product. Intergity testing of filters. Reduction of impurity bioburden. Viral inactivation.
Characterization of finished biopharmaceutical products.
In-process and final product testing. Detection and determination of yield, purity, concentration and biological activity.
Practical laboratory sessions
Extraction and purification of a recombinant protein using chromatography (ion-exchange; affinity chromatography). Investigation of bioactivity following purification (immunoblot enzyme assay; electrophoresis.)
Module Assessment
Assessment Breakdown%
Course Work20.00%
Practical30.00%
Final Examination50.00%
Module Special Regulation
 

Assessments

Full-time

Course Work
Assessment Type Written Report % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing S2 Week 26 Learning Outcome 5
Duration in minutes 0
Assessment Description
Students will produce a report and numerically evaluate set tasks following a 1 day specialised workshop in the National Institute for Bioprocessing Research and Training (NIBRT) in UCD. During the workshop, students will compare biopharmaceutical downstream processes from laboratory to industrial scale eg chromatography, filtration. Students will be assessed on their understanding and analysis of the techniques practiced.
Assessment Type Class Test % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing S2 Week 25 Learning Outcome 1
Duration in minutes 0
Assessment Description
Evaluate understanding and application of knowledge gained in lectures
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 30
Marks Out Of 0 Pass Mark 0
Timing Every Week Learning Outcome 4,5
Duration in minutes 0
Assessment Description
Students will participate in weekly based laboratory practical sessions. Summative practical laboratory reports will be submitted. Marks for these reports will be based on report writing skills as well as practical ability.
Final Examination
Assessment Type Formal Exam % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
A 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.

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full-time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact 2 x 1 hour lectures Every Week 2.00 2
Practical Contact 1 x 3 hour lab session Every Week 3.00 3
Tutorial Contact No Description Every Week 1.00 1
Directed Reading Non Contact Notes/paper/Textbook reading Every Week 3.00 3
Independent Study Non Contact Self / group study Every Week 3.00 3
Total Weekly Learner Workload 12.00
Total Weekly Contact Hours 6.00
This module has no Part-time workload.
 
Module Resources
Recommended Book Resources
  • Walls and Loughran. (2011), Protein Chromatography “Methods and Protocols”, 2011, Humana Press, [ISBN: 9781607619123].
  • Michael Gromiha. (2010), Protein Bioinformatics (from sequence to function), Academic Press, [ISBN: 9788131222973].
  • Clark and Pazdernik. Biotechnology, Academic Cell, [ISBN: 9780123850638].
  • Walsh, G.. (2007), Pharmaceutical biotechnology: Concepts and applications, J. Wiley and Sons, [ISBN: 9780470012444].
  • Ghosh. (2006), Principles of Bioseparations Engineering, World Scientific Publishing, [ISBN: 9812568921].
  • Various. (2004), ISPE baseline guide for biotechnology, ISPE.
  • Petsko, G.A. and Ringe, D.. (2004), Protein structure and function, Blackwell Press.
  • Walsh, G.. (2003), Biopharmaceuticals: Biochemistry and biotechnology., J. Wiley and Sons.
  • Nash, R.A. and Wachter, A.H.. (2003), Pharmaceutical process validation, 2nd. Marcel Dekker.
  • Roe, S.. (2001), Protein purification techniques : A practical approach, Oxford University Press.
  • Reinhard Renneberg. Biotechnology for Beginners, Academic Press, [ISBN: 9783827418470].
Recommended Article/Paper Resources
  • Petra Gronemeyer, Reinhard Ditz and Jochen Strube. (2014), Trends in Upstream and Downstream Process Development for Antibody Manufacturing, Bioengineering, 1, [ISSN: 2306-5354].
  • WEI WANG, ARUN ALPHONSE IGNATIUS, SANTOSH V. THAKKAR. (2014), Impact of Residual Impurities and Contaminants on Protein, JOURNAL OF PHARMACEUTICAL SCIENCES.
  • Sanchayita Ghose,Yinying Tao, Lynn Conley and Douglas Cecchini. (2013), Purification of monoclonal antibodies, Landes Bioscience, 5, p.5.
  • A. S. Rathore & A. Shirke. (2011), RECENT DEVELOPMENTS IN MEMBRANE BASED, Preparative Biochemistry & Biotechnology, 41, [ISSN: 1082-6068].
  • Mariusz Kamionka. (2011), Engineering of Therapeutic Proteins Production in Escherichia coli, Current Pharmaceutical Biotechnology, 12.
  • Rachel C. Houp. (2009), Ultrafiltration and Diafiltration, Journal of Validation Technology.
  • Geng Xindu, Wang Lili. (2008), Liquid chromatography of recombinant proteins and protein drugs, Journal of Chromatography B, 866, p.20.
Other Resources