MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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Course unit details:
Application of Microbiology in Biopharmaceuticals (PMAT 7)

Unit code PHAR71360
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit conducts a review of the current Legislation & Guidelines in Biopharmaceuticals. It covers Microbial contamination risks and the strategies to prevent contamination, and describes and analyses Microbial test Methods for Biotechnology Products, bioburden, endotoxin, mycoplasma and viruses.. The unit conducts a detailed look at Biopharmaceutical Technology (growth techniques, cell & tissue culture, fermentation, purification, harvesting, final drug products), and reviews process methods and technology used to limit and remove contamination such as SIP, CIP, disposables.

 

Aims

The unit aims to enable students to:

  • Obtain an advanced knowledge and in-depth understanding of the contamination control issues associate with biopharmaceutical processing so that risks can be assessed and mitigated
  • Understand biopharmaceutical processing, how process stages affect the product, in particular, microbial contamination, so that a process can be designed to limit risks and reduce contamination
  • Interpret the legislation and guidance associated with biopharmaceuticals and apply them to manufacture and control.
  • Acquire an in depth understanding of the microbial test (including viral) applied to biopharmaceuticals and be able to apply them to different biopharmaceutical product types and processes

 

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 7 chapters covering key areas of applying microbiology concepts in biopharmaceuticals. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.

Knowledge and understanding

Students should be able to demonstrate an advanced knowledge and detailed understanding of:

  • Biopharmaceutical legislation and guidelines
  • Bacterial fermentation
  • Mammalian cell culture
  • Key manufacturing steps
  • Use of disposable
  • Clean in place (CIP) Steam in Place (SIP)
  • Contamination control of TSE bioburden, endotoxin, mycoplasma and viruses
  • Contamination risks and management
  • Viral control strategies
  • Microbial test methods
  • Microbial test regimes

Intellectual skills

Students should be able to:

Interpret, analyse, assess legislation and guidelines associated with biopharmaceuticals and make decisions on how they should be applied

Critically analyse, evaluate so that informed judgements can be made about:

  • Management and mitigation of microbial risk
  • Current process methods and technologies
  • Development of microbial testing regimes
  • The selection of microbial test methods
  • Viral control strategies

Practical skills

Students should be able to:

  • Complete exercises to demonstrate an understanding of the application of knowledge derived from the course material
  • Application of knowledge gained in in the work place for example risk assessment of processes

Transferable skills and personal qualities

Students should be able to:

  • Critique information from a range of sources to formulate opinions and make decisions
  • Manage contamination control issues using Quality Risk Assessments
  • Develop expertise in microbial test methods and how they should be applied
  • Assess microbial control based on the knowledge and experience gained and adapt working practices as necessary

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

The student is required to complete a written assignment for summative assessment.

3,000 words

Feedback returned by email within 15 working days.

100%

Formative assessments are included throughout the text.

N/A

N/A

N/A

 

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use: 
Part II: Basic Requirements for Active Substances used as Starting Materials. Section 18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation. 
Part I - Basic Requirements for Medicinal Products. Annex II, Manufacture of Biological active Substances and Medicinal Products for Human Use. 
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
•    ABC’s of Gene Cloning by D W S Wong (2nd edition) published 2006
•    Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu, Biotechnology Quality Assurance and Validation, Interpharm/CRC
•    Disposables Bioprocessing Systems Sarfaraz K. Niazi CRC Press; 1 edition (1 Feb 2012)
•    Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu, Biotechnology Quality Assurance and Validation, Interpharm/CRC 
•    Rosamund M. Baird, Norman A. Hodges and Stephen P. Denyer Handbook of Microbial Quality Control, Taylor and Frances
 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Paul Newby Unit coordinator

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