MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

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

A review of the current Legislation & Guidelines in Biopharmaceuticals will be conducted. Microbial contamination risks and the strategies to prevent contamination will be covered. Microbial test Methods for Biotechnology Products, bioburden, endotoxin, mycoplasma and viruses will be described and analysed. A detailed look at Biopharmaceutical Technology (growth techniques, cell & tissue culture, fermentation, purification, harvesting, final drug products) will be conducted. Process methods and technology used to limit and remove contamination such as SIP, CIP, disposables, will be reviewed.

 

Aims

The unit aims to enable students to:

  • Acquire an advanced knowledge and in depth understanding of the contamination control issues associate with biopharmaceutical processing so that risks can be assessed and mitigated
  • To 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
  • To be able to 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

This module mainly delivered through distance learning. A printed manual consisting of 8 chapters is issued to the student on registration and receipt of payment. The module is designed to contain 100 hours of assessed learning.

Additional learning activities are directed which, together with the assessment require 50 hours of self directed learning and assessment.

 

Weekend Summer School - Workshop sessions

Case studies

Presentation

Syndicate sessions

 

Knowledge and understanding

Self-directed learning

Formative assessments at the end of each chapter

 

Practical skills

Reflective diary

Self-directed learning

 

Transferable skills and personal qualities

Work based learning

Self-directed learning

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:

The ability to critique information from a range of sources to formulate opinions and make decisions

The management of contamination control issues using  Quality Risk Assessments

Expertise in microbial test methods and how they should be applied

The ability to assess microbial control based on the knowledge and experience gained and adapt working practices as necessary

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

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 is provided by the tutor after marking submitted assignments.

30%

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

3 hours

N/A

70%

Formative assessments are included throughout the text.

N/A

N/A

N/A

 

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Matthew Shaw Unit coordinator

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