Title MICROBIOLOGICAL & BIOTECHNOLOGICAL ASPECTS OF

MEDICINE PRODUCTION
Code BY349
Level 6
Credit rating 20 Points
Pre-requisites BY241
Type of module Extensive, Semesters 1 and 2
Aims • To raise awareness regarding the importance of micro-organisms
as both potential producers and contaminants of medicinal
products
• To provide students with an understanding of the principles and
procedures involved in hygienic manufacture of pharmaceutical
products, the use of anti-microbial agents, product sterilisation and
preservation
• To introduce students to biotechnology-based pharmaceuticals,
both traditional and modern, their development, production and
clinical use
Learning On completion of this module the student should be able to:
outcomes/objectives
1. apply knowledge of the principles and procedures involved in
hygienic manufacture of pharmaceutical products, the use of anti-
microbial agents, product sterilisation and preservation
2. exercise judgement on the development, production and use of
biotechnology-based pharmaceuticals
3. consolidate and extend competence in practical aspects
relating to the above
Content Theme 1: Principles and processes of pharmaceutical
biotechnology

Lectures 1 Introduction and overview

• Definitions: products of pharmaceutical
biotechnology, biologics, biopharmaceuticals
• Processes involved in their production
Lecture 2-3 Molecular Biotechnology
• Recombinant DNA technology
• Vector systems
Lecture 3-6 Production and downstream processing of biotech
compounds
• Expression systems
• Batch culture and large scale fermentations
• Plant and animal cell culture systems
• Downstream processing & quality control
Lecture 7 Formulation and delivery of biotech products
Lecture 8 QAA and regulatory issues relating to biotech products
• EMEA guidelines on similar biological
medicinal products

Practical classes (4h)

1. Restriction digestion of phage lambda DNA

Theme 2: Products of pharmaceutical biotechnology and their

uses

Lecture 1 Introduction to products of pharmaceutical biotechnology

• Traditional pharmaceuticals of biological origin
(animal, plant and microbial)
• Products of molecular biotechnology
• Differences between macromolecules and
 small molecule drugs
Lectures 2-3 Traditional pharmaceuticals of microbial origin
• Commerical production of penicillin
• Microbial transformation of steroids
Lectures 4-8 Recombinant therapeutic proteins
• Therapeutic proteins and their uses (Growth
factors, interferons & interleukins, hormones,
coagulation factors and thrombolytic agents).
Bioassay and biological standards.
• Antibody biotechnology
• Pharmacokinetics and pharmacodynamics of
peptide and protein drugs
• Immunogenicity of therapeutic proteins
Lectures 9-10 Nucleic acid-based biologics
• Gene therapy vectors: targets, delivery
systems & safety aspects
• DNA-based diagnostics: techniques & practical
issues
Lecture 11 Cell-based biologics
• Cell therapy
• Tissue engineering

Theme 3: Sterilisation and sterility testing

Lecture 1 Introduction to product sterility

• Sterile vs non-sterile pharmaceutical products
• Pharmacopoeial limits in non-sterile products
• Terminal sterilisation vs aseptic manufacture
Lecture 2 Aseptic manufacture
• Categories of products manufactured
aseptically
• Design of pharmaceutical clean rooms
• Environmental monitoring
Lectures 3-4 Kinetics of antimicrobial action
• Parameters used in the design and monitoring of
sterilization processes
• D, Z and Fo values
Lectures 5-9 Physical methods of sterilisation
• Moist heat , Dry heat , Ionising radiation, Gaseous,
Filtration
• Mechanics of the sterilisation process
• Advantages/disadvantages of the process
• Materials for which the process is suitable/unsuitable
• Standard reference conditions
Lectures 10-11 Validation and monitoring of sterilisation
• Biological indicators
• Sterility testing
• Pharmacopoeial and regulatory requirements
Lecture 12 Pyrogen and endotoxin testing
• LAL tests

Practical classes (12h)

1. Bioburden determination
2. Steam sterilisation
3. Sterility testing tutorial
 Theme 4: Antimicrobial agents: Activity, efficacy testing and
product preservation

Lecture 1 Measurement of antimicrobial activity

• Factors influencing accuracy & reproducibility
Lecture 2 Antimicrobial efficacy
• Minimum inhibitory concentrations of antibiotics
• Disinfectant performance and use in relation to
contamination control in hospital and industrial
setting
Lecture 3 Antibiotic assays
• Methods
• Circumstances when undertaken
• The influence of sample characteristics on
assay selection
Lectures 4-7 Product preservation
• Measurement of preservative efficacy
• Contamination and spoilage of pharmaceutical
raw materials and manufactured medicines
• Factors influencing activity of preservatives
• Preservatives available, their characteristics
and applications

Practical classes (6h)

1. Biocide and antibiotic activity

Teaching and learning The material will be presented by formal lectures (approximately 38 hrs)
strategies and practical classes (22 hrs) and will be supported by guided study
(approximately 140 hrs including assessment).
Learning support Texts (current editions)

Pharmaceutical Microbiology. , SP, Hodges, NA, and Gorman, SP

Blackwell Science.
Handbook of Microbiological Quality Control. Baird, R, Hodges, NA and
Denyer, SP, Taylor & Francis.
Pharmaceutics: the Science of Dosage Form Design. Aulton, M E.,
Churchill Livingstone.
Principles and Practice of Disinfection, Preservation and Sterilisation,
Fraise A, Lambert P and Maillard J-Y, Blackwell Science.
Guide to Microbiological Control in Pharmaceutical and Medical
Devices. Denyer, SP and Baird, R , Taylor and Francis.
British and European Pharmacopoeias
Pharmaceutical biotechnology: fundamentals and applications. DJA
Crommelin R.D. Sindelar & B. Maibohm (eds), London : Routledge
Biopharmaceuticals: biochemistry and biotechnology. Walsh, G, Wiley.
Instant notes in Molecular Biology. Turner, P., McLennan, A., Bates, A
& White, M, Taylor & Francis
Assessment tasks Two hour end of module written examination (60%) (LO1, 2), and
continuous assessment of manipulative laboratory exercises (40%)
(LO3). The threshold for each component is 35%.
Brief description of This module builds upon the information contained in BY241, and
module content and/or concentrates on the features of microbiology which are of practical
aims (maximum 80 words) interest and concern in pharmacy, i.e. the means by which microbial
growth can be restricted or prevented and the exploitation of microbes
in medicine production. In addition it seeks to provide the student with
an insight into the current and potential applications of the so-called
'new biology' to the pharmaceutical industry.
Area examination board to Biology and Biomedical Sciences
which module relates
Module K.Jennert-Burston, L. Barnes, G. Hanlon, B. Jones & N. Hodges
team/authors/coordinator
Semester offered, where 1 and 2
appropriate
Site where delivered Moulsecoomb
Date of first approval 2008
Date of last revision
Date of approval of this 2008
version
Version number 1
Replacement for previous CH333
module
Field for which module is Pharmacy, Compulsory
acceptable and status in
that field
Course(s) for which MPharm. Compulsory.
module is acceptable and
status in that course
School home Pharmacy and Biomolecular Sciences
External examiner Keith Kitson